Pharmacovigilance (Drug Safety) — P1

Goal templates — Pharmacovigilance (Drug Safety) — P1

Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) · P1 — Entry-Level Professional

These are canon-derived frames, not advice: every line is either verbatim JobFrame canon text or a fixed template wrapping it. ⟨target⟩ / ⟨baseline⟩ / ⟨date⟩ are placeholders for the manager to fill in. Nothing here is generated by AI — rows are omitted, never invented, when the canon lacks the underlying field.

SMART goals

One row per canon core output / responsibility this level owns.

JFM responsibility (P1)

Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines

Specific
Deliver: "Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
Relevant
Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
Time-bound
⟨date⟩

JFM responsibility (P1)

Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures

Specific
Deliver: "Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
Relevant
Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
Time-bound
⟨date⟩

JFM responsibility (P1)

Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates

Specific
Deliver: "Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
Relevant
Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
Time-bound
⟨date⟩

JFM responsibility (P1)

Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions

Specific
Deliver: "Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
Relevant
Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
Time-bound
⟨date⟩

JFM responsibility (P1)

Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff

Specific
Deliver: "Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
Relevant
Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
Time-bound
⟨date⟩
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1. Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines  [source: JFM responsibility (P1)]
   Specific:    Deliver: "Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
   Time-bound:  ⟨date⟩

2. Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures  [source: JFM responsibility (P1)]
   Specific:    Deliver: "Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
   Time-bound:  ⟨date⟩

3. Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates  [source: JFM responsibility (P1)]
   Specific:    Deliver: "Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
   Time-bound:  ⟨date⟩

4. Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions  [source: JFM responsibility (P1)]
   Specific:    Deliver: "Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
   Time-bound:  ⟨date⟩

5. Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff  [source: JFM responsibility (P1)]
   Specific:    Deliver: "Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P1 — Entry-Level Professional.
   Time-bound:  ⟨date⟩

OKRs

Objectives from this level's core outputs; key results only where a real dimension or capability backs them.

JFM responsibility (P1)

Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines"
  • Evidence at this level's scope bar: "Own tasks within a defined component" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P1)

Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures"
  • Evidence at this level's autonomy bar: "Close supervision; work reviewed frequently" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P1)

Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates"
  • Evidence at this level's complexity bar: "Routine problems with known solutions" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P1)

Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions"
  • Evidence at this level's impact bar: "Own deliverables" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P1)

Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff"
  • Evidence at this level's decision rights bar: "Few independent decisions; escalates the rest" — ⟨target⟩ by ⟨date⟩
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Objective 1: Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines  [source: JFM responsibility (P1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines"
  KR2. Evidence at this level's scope bar: "Own tasks within a defined component" — ⟨target⟩ by ⟨date⟩

Objective 2: Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures  [source: JFM responsibility (P1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures"
  KR2. Evidence at this level's autonomy bar: "Close supervision; work reviewed frequently" — ⟨target⟩ by ⟨date⟩

Objective 3: Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates  [source: JFM responsibility (P1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates"
  KR2. Evidence at this level's complexity bar: "Routine problems with known solutions" — ⟨target⟩ by ⟨date⟩

Objective 4: Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions  [source: JFM responsibility (P1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions"
  KR2. Evidence at this level's impact bar: "Own deliverables" — ⟨target⟩ by ⟨date⟩

Objective 5: Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff  [source: JFM responsibility (P1)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff"
  KR2. Evidence at this level's decision rights bar: "Few independent decisions; escalates the rest" — ⟨target⟩ by ⟨date⟩

MBO areas

Key result areas from this level's responsibilities, each with a standard grounded in the canon leveling rubric where one exists.

AreaStandardTargetDue
Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelinesConsistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."⟨target⟩⟨date⟩
Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing proceduresConsistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."⟨target⟩⟨date⟩
Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associatesConsistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."⟨target⟩⟨date⟩
Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructionsConsistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."⟨target⟩⟨date⟩
Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staffConsistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."⟨target⟩⟨date⟩
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1. Area: Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines  [source: JFM responsibility (P1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."
   Target:   ⟨target⟩   Due: ⟨date⟩

2. Area: Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures  [source: JFM responsibility (P1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."
   Target:   ⟨target⟩   Due: ⟨date⟩

3. Area: Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates  [source: JFM responsibility (P1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."
   Target:   ⟨target⟩   Due: ⟨date⟩

4. Area: Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions  [source: JFM responsibility (P1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."
   Target:   ⟨target⟩   Due: ⟨date⟩

5. Area: Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff  [source: JFM responsibility (P1) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs."
   Target:   ⟨target⟩   Due: ⟨date⟩

Scorecard

Only perspectives with real canon backing are shown — no Financial or Customer perspective, since nothing in the canon grounds business-financial or customer measures for a role alone.

Internal process

  • "Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines"⟨target⟩ by ⟨date⟩
  • "Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures"⟨target⟩ by ⟨date⟩
  • "Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates"⟨target⟩ by ⟨date⟩
  • "Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions"⟨target⟩ by ⟨date⟩
  • "Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff"⟨target⟩ by ⟨date⟩

Role calibration

  • Meets the scope bar: "Own tasks within a defined component"⟨target⟩ by ⟨date⟩
  • Meets the autonomy bar: "Close supervision; work reviewed frequently"⟨target⟩ by ⟨date⟩
  • Meets the complexity bar: "Routine problems with known solutions"⟨target⟩ by ⟨date⟩
  • Meets the impact bar: "Own deliverables"⟨target⟩ by ⟨date⟩
  • Meets the decision rights bar: "Few independent decisions; escalates the rest"⟨target⟩ by ⟨date⟩
  • Meets the leadership bar: "None — building the craft"⟨target⟩ by ⟨date⟩
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Internal process
  - "Collects and triages incoming adverse event reports under close supervision, ensuring every safety report is documented and logged within mandated timelines"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P1)]
  - "Performs data entry of individual case safety reports into drug safety databases such as Oracle Argus or ArisGlobal following standard case-processing procedures"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P1)]
  - "Applies MedDRA coding to standardise adverse event medical terminology, escalating ambiguous terms to senior associates"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P1)]
  - "Captures drug identifiers correctly and verifies event reports contain sufficient detail for evaluators, following detailed work instructions"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P1)]
  - "Supports submission of completed cases to regulatory authorities (EMA, MHRA, FDA) under review of mid-level staff"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P1)]

Role calibration
  - Meets the scope bar: "Own tasks within a defined component"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Scope)]
  - Meets the autonomy bar: "Close supervision; work reviewed frequently"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Autonomy)]
  - Meets the complexity bar: "Routine problems with known solutions"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Complexity)]
  - Meets the impact bar: "Own deliverables"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Impact)]
  - Meets the decision rights bar: "Few independent decisions; escalates the rest"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Decision rights)]
  - Meets the leadership bar: "None — building the craft"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Leadership)]