Goal templates — Pharmacovigilance (Drug Safety) — P2

Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) · P2 — Developing 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 (P2)

Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures

Specific: Deliver: "Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
Relevant: Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
Time-bound: ⟨date⟩

JFM responsibility (P2)

Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases

Specific: Deliver: "Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
Relevant: Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
Time-bound: ⟨date⟩

JFM responsibility (P2)

Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)

Specific: Deliver: "Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
Relevant: Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
Time-bound: ⟨date⟩

JFM responsibility (P2)

Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs

Specific: Deliver: "Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
Relevant: Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
Time-bound: ⟨date⟩

JFM responsibility (P2)

Mentors junior associates on case intake, triage, and coding conventions

Specific: Deliver: "Mentors junior associates on case intake, triage, and coding conventions"
Measurable: Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable: Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
Relevant: Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
Time-bound: ⟨date⟩

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1. Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures  [source: JFM responsibility (P2)]
   Specific:    Deliver: "Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
   Time-bound:  ⟨date⟩

2. Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases  [source: JFM responsibility (P2)]
   Specific:    Deliver: "Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
   Time-bound:  ⟨date⟩

3. Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)  [source: JFM responsibility (P2)]
   Specific:    Deliver: "Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
   Time-bound:  ⟨date⟩

4. Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs  [source: JFM responsibility (P2)]
   Specific:    Deliver: "Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing Professional.
   Time-bound:  ⟨date⟩

5. Mentors junior associates on case intake, triage, and coding conventions  [source: JFM responsibility (P2)]
   Specific:    Deliver: "Mentors junior associates on case intake, triage, and coding conventions"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward."
   Relevant:    Advances the Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety) mandate for a P2 — Developing 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 (P2)

Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures"
Evidence at this level's scope bar: "Defined deliverables / small features" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P2)

Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases"
Evidence at this level's autonomy bar: "General supervision; reviewed at milestones" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P2)

Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)"
Evidence at this level's complexity bar: "Some non-routine problems; applies established patterns" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P2)

Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs"
Evidence at this level's impact bar: "Own and immediate-team deliverables" — ⟨target⟩ by ⟨date⟩

JFM responsibility (P2)

Mentors junior associates on case intake, triage, and coding conventions

From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Mentors junior associates on case intake, triage, and coding conventions"
Evidence at this level's decision rights bar: "Routine technical choices within guidance" — ⟨target⟩ by ⟨date⟩

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Objective 1: Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures  [source: JFM responsibility (P2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures"
  KR2. Evidence at this level's scope bar: "Defined deliverables / small features" — ⟨target⟩ by ⟨date⟩

Objective 2: Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases  [source: JFM responsibility (P2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases"
  KR2. Evidence at this level's autonomy bar: "General supervision; reviewed at milestones" — ⟨target⟩ by ⟨date⟩

Objective 3: Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)  [source: JFM responsibility (P2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)"
  KR2. Evidence at this level's complexity bar: "Some non-routine problems; applies established patterns" — ⟨target⟩ by ⟨date⟩

Objective 4: Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs  [source: JFM responsibility (P2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs"
  KR2. Evidence at this level's impact bar: "Own and immediate-team deliverables" — ⟨target⟩ by ⟨date⟩

Objective 5: Mentors junior associates on case intake, triage, and coding conventions  [source: JFM responsibility (P2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Mentors junior associates on case intake, triage, and coding conventions"
  KR2. Evidence at this level's decision rights bar: "Routine technical choices within guidance" — ⟨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.

Area	Standard	Target	Due
Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures	Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."	⟨target⟩	⟨date⟩
Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases	Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."	⟨target⟩	⟨date⟩
Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)	Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."	⟨target⟩	⟨date⟩
Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs	Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."	⟨target⟩	⟨date⟩
Mentors junior associates on case intake, triage, and coding conventions	Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."	⟨target⟩	⟨date⟩

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1. Area: Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures  [source: JFM responsibility (P2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."
   Target:   ⟨target⟩   Due: ⟨date⟩

2. Area: Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases  [source: JFM responsibility (P2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."
   Target:   ⟨target⟩   Due: ⟨date⟩

3. Area: Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)  [source: JFM responsibility (P2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."
   Target:   ⟨target⟩   Due: ⟨date⟩

4. Area: Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs  [source: JFM responsibility (P2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."
   Target:   ⟨target⟩   Due: ⟨date⟩

5. Area: Mentors junior associates on case intake, triage, and coding conventions  [source: JFM responsibility (P2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts."
   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

"Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures"→ ⟨target⟩ by ⟨date⟩
"Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases"→ ⟨target⟩ by ⟨date⟩
"Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)"→ ⟨target⟩ by ⟨date⟩
"Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs"→ ⟨target⟩ by ⟨date⟩
"Mentors junior associates on case intake, triage, and coding conventions"→ ⟨target⟩ by ⟨date⟩

Role calibration

Meets the scope bar: "Defined deliverables / small features"→ ⟨target⟩ by ⟨date⟩
Meets the autonomy bar: "General supervision; reviewed at milestones"→ ⟨target⟩ by ⟨date⟩
Meets the complexity bar: "Some non-routine problems; applies established patterns"→ ⟨target⟩ by ⟨date⟩
Meets the impact bar: "Own and immediate-team deliverables"→ ⟨target⟩ by ⟨date⟩
Meets the decision rights bar: "Routine technical choices within guidance"→ ⟨target⟩ by ⟨date⟩
Meets the leadership bar: "May guide interns"→ ⟨target⟩ by ⟨date⟩

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Internal process
  - "Processes complex ICSRs end-to-end, applying MedDRA and WHODrug coding and resolving routine case discrepancies independently within defined procedures"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P2)]
  - "Authors case narrative reports describing the adverse event, medical history, and assessment for serious and non-serious cases"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P2)]
  - "Submits serious cases to FDA, EMA, and MHRA via E2B(R3) electronic gateways within mandated reporting clocks (e.g., 15 days for serious cases)"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P2)]
  - "Supports inspection and audit readiness by maintaining accurate case records and reconciliation logs"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P2)]
  - "Mentors junior associates on case intake, triage, and coding conventions"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (P2)]

Role calibration
  - Meets the scope bar: "Defined deliverables / small features"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Scope)]
  - Meets the autonomy bar: "General supervision; reviewed at milestones"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Autonomy)]
  - Meets the complexity bar: "Some non-routine problems; applies established patterns"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Complexity)]
  - Meets the impact bar: "Own and immediate-team deliverables"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Impact)]
  - Meets the decision rights bar: "Routine technical choices within guidance"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Decision rights)]
  - Meets the leadership bar: "May guide interns"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Leadership)]