Pharmacovigilance (Drug Safety) — P6

PHARMA.PHARMACOA353.P6

P6P6 — Principal Professionalhigh0.80approvedglobalv1

Scientific and operational pharmacovigilance covering the full ICSR lifecycle (collection, triage, coding, regulatory submission), signal detection, aggregate safety reporting, benefit-risk evaluation, and PV system oversight. Distinct from Regulatory Affairs (product registration/labeling submissions) and Clinical Operations (trial conduct); focus here is on post-marketing and clinical safety surveillance under GVP/ICH-GCP.

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Level

P6 · P6 — Principal Professional · 12–18 yrs

Function · Focus

Pharmacovigilance (Drug Safety) · Pharmacovigilance (Drug Safety)

Market pay (median)

$153k ($120k–$195k)

Pay basis

function-anchored · wide bars

Focus — Pharmacovigilance (Drug Safety)

Responsibilities by level

What this person actually does at each level on the professional track — escalating scope, not one generic blob. Your level is highlighted.

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

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

Acts as case processing lead or aggregate reporting specialist, coordinating case workflow and quality across a defined product or therapeutic area with milestone review
Contributes to aggregate safety reports (PSURs/PBRERs, DSURs, RMPs), drafting assigned sections and reconciling case data
Performs early signal detection activities, reviewing aggregated data and disproportionality outputs (PRR, ROR) to flag emerging patterns
Plans own day-to-day case and reporting work, networking with safety physicians and senior PV scientists to resolve medical assessment questions
Coordinates audit and inspection support activities, preparing case-level documentation and responding to evaluator queries

Leads signal detection and preliminary benefit-risk evaluation for assigned products, selecting disproportionality methods (MGPS, BCPNN) and integrating real-world evidence
Authors and develops complete aggregate safety reports (PSURs, DSURs, RMPs) and defends content to internal review boards and authorities
Conducts safety surveillance in compliance with global GVP and ICH-GCP, performing in-depth scientific analysis of complex safety datasets
Coordinates across PV operations, regulatory, and risk management groups, and may lead a case-processing or aggregate-reporting team
Influences product-level safety decisions and method selection, mentoring P2/P3 scientists on scientific assessment

Drives PV strategy across multiple products or a therapeutic area, acting independently on signal-to-benefit-risk decisions that contribute to company safety objectives
Owns benefit-risk reassessment when new risks emerge, integrating real-world evidence, epidemiology, and disproportionality analysis to guide risk-minimisation strategy
Develops and manages risk management plans and post-marketing safety studies in collaboration with safety physicians and risk management leadership
Serves as PV scientific spokesperson in interactions with EMA/national competent authorities and at safety governance forums
Builds influential cross-functional networks and supervises scientists on complex or high-visibility safety assignments

P6this profile

Ensures the marketing authorization holder's PV system is robust, compliant, and continuously improving across all products and therapeutic areas (QPPV-level accountability)
Serves as the regulatory single point of contact for EMA and national competent authorities, available 24/7, retaining ultimate non-transferable accountability for the PV system
Supervises the entire quality system applied to pharmacovigilance, ensuring SOPs, staff training, data quality, and ICSR submission timelines meet regulatory expectations
Maintains comprehensive overview of products' safety and benefit-risk profiles and leads reassessment and escalation when significant new risks emerge
Provides organization-wide medical and scientific leadership in drug safety and risk management strategy, mentoring senior PV scientists and influencing industry practice

Level guidelines

The universal leveling rubric applied to this function — how scope, complexity, collaboration, and experience step up across levels.

Level	Knowledge & Application	Complexity & Problem Solving	Collaboration & Interaction	Typical Degree & Years
P1	Applies basic pharmacovigilance and MedDRA coding conventions to routine case intake and data entry; relies on detailed work instructions and SOPs.	Handles routine case triage and entry problems with standard answers; escalates ambiguous medical terms and complex cases.	Works within a stable internal case-processing team; interacts with senior associates for guidance and clarification.	0-1 years; new graduate or intern, often with a life-sciences or nursing/pharmacy background.
P2	Applies established case-processing, MedDRA/WHODrug coding, and E2B submission procedures to complex ICSRs in familiar contexts.	Exercises judgment resolving routine case discrepancies and narrative content within defined procedures; refers novel issues upward.	Builds productive project relationships across PV operations; mentors junior associates on intake and coding.	2+ years in case processing with a BA/BS, or an MS/PhD with limited experience.
P3	Evaluates identifiable safety factors across diverse cases and products; applies signal-detection fundamentals and GVP knowledge with growing independence.	Assesses diverse case and reporting problems, reconciles aggregate data, and interprets disproportionality outputs with moderate independence.	Networks with safety physicians and senior PV scientists; may coordinate case-processing or aggregate-reporting activities.	5+ years (BA), 3+ years (MA), or PhD without prior experience.
P4	Applies in-depth scientific analysis of complex safety variables, selecting disproportionality methods and integrating real-world evidence across products.	Analyzes complex, multi-source safety datasets to drive signal evaluation and aggregate-report conclusions with functional impact.	Coordinates across PV, regulatory, and risk management groups; may lead teams and influence product-level safety decisions.	8+ years in pharmacovigilance, often with graduate education.
P5	Brings expert benefit-risk and risk-management mastery to strategic, often ambiguous safety issues spanning multiple products or a therapeutic area.	Resolves intangible safety questions independently, balancing epidemiology, RWE, and statistics to shape risk-minimisation strategy.	Builds influential internal and external networks; acts as scientific spokesperson with regulatory authorities and safety forums.	12+ years with extensive PV and benefit-risk expertise.
P6	Provides field-defining, organization-wide authority over the PV system, quality, and benefit-risk governance under EMA/MHRA QPPV expectations.	Leads visionary, system-level problem-solving on critical safety escalations, with full latitude and ultimate accountability for the PV system.	Serves as the recognized 24/7 single point of contact for competent authorities; influences industry and mentors senior scientists.	15+ years; principal PV expert, often a physician or PhD with regulatory and leadership standing.

Skills

Focus-specific skills the role applies — the relevance layer beyond the occupational base.

Adverse event case processing: Collection, triage, and management of individual case safety reports (ICSRs) through the full case lifecycle.
MedDRA coding: Use of the Medical Dictionary for Regulatory Activities to standardise and code adverse event medical terminology across global regulatory agencies.
WHODrug coding: Coding of medicinal products using the WHODrug dictionary.
Regulatory reporting: Submitting safety cases to authorities such as FDA, EMA, and MHRA within mandated timelines (e.g., 15 days for serious cases).
Electronic submission standards (E2B): Exchange and submission of cases using the ICH E2B standard, including E2B(R3) data elements and regional gateways such as FAERS.
Signal detection: Identifying patterns and emerging safety risks across aggregated data, including disproportionality analysis.
Disproportionality statistics: Statistical methods used in signal detection including PRR, ROR, MGPS, and BCPNN.
Narrative report writing: Authoring case narratives describing adverse events and their assessment.
Aggregate report authoring: Writing periodic safety documents such as PSURs/PBRERs, DSURs, and RMPs.
Benefit-risk evaluation: Maintaining and reassessing the overall safety profile and benefit-risk balance of products.
ICH-GCP and GVP knowledge: Fluency in ICH Good Clinical Practice and Good Pharmacovigilance Practices guidelines.
Drug development knowledge: Understanding of the drug development process and life-sciences scientific foundation.
Real-world evidence: Use of real-world data to identify and validate safety signals beyond traditional ICSR volume spikes.
Risk management: Developing and managing risk management plans and post-marketing safety studies.
Oracle Argus: Uses this tool/technology effectively during the delivery of day-to-day tasks.
ArisGlobal: Uses this tool/technology effectively during the delivery of day-to-day tasks.
StataCorp Stata: Uses this tool/technology effectively during the delivery of day-to-day tasks.
MetricStream: Uses this tool/technology effectively during the delivery of day-to-day tasks.

Provenance

The evidence base behind this profile — every layer is sourced; quality is scored by an adversarial review panel (1–5; passes at ≥4 on the minimum dimension).

Level differentiation4.0Focus specificity5.0Concreteness4.5Factual accuracy4.5Real-world coverage4.5

8 sources

Level — P6 — Principal Professional

Top individual contributor; recognized authority with strategic impact, equivalent to a low executive level

Scope: Organization-wide architecture and the hardest problems
Autonomy: Defines direction; minimal oversight
Complexity: Strategic, open-ended problems shaping the technical future
Impact: Organization-wide
Decision rights: Sets technical strategy for a major area
Leadership: Recognized authority; multiplies many teams
Typical experience: 12–18 yrs

Adjacent roles

Nearest roles by structural coordinates (level + taxonomy). Distance 0 → 1; each carries its 3-state match band. How coordinates work → · Compare side-by-side →

PHARMA.PHARMACOA353.P5

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PHARMA.PHARMACOA353.P3

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PHARMA.PHARMACOA353.P2

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