Global PV Safety Physician & Strategy Leader (Remote)

BioSpace

Radnor (Delaware County)

Remote

USD 188,000 - 312,000

Full time

33 hours ago
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Job summary

Immunocore is seeking a Senior Director, Global Pharmacovigilance (Safety Physician) to lead medical safety strategy for development and marketed products. The role oversees signal detection, regulatory submissions, and risk management, guiding a team of PV physicians and safety professionals across the product lifecycle.

This senior medical leader will interact with global Health Authorities, shape PV plans, and ensure high-quality safety reporting and lifecycle safety management for complex

Qualifications

  • MD/DO degree with at least five years of pharmacovigilance experience, and at least two years of clinical experience or relevant experience to understand clinical drug development.
  • Board certification in a relevant specialty.

Responsibilities

  • Develop and implement global pharmacovigilance strategies for assigned products, aligned with clinical, regulatory, and commercial objectives.
  • Lead ongoing benefit–risk assessments using data from clinical trials, post marketing surveillance, real world data sources, and epidemiologic/active safety studies.
  • Oversee systematic signal detection and evaluation from Individual Case Safety Reports, aggregate/periodic reports, literature, and other data sources.
  • Direct the design, conduct, and interpretation of active safety surveillance and pharmacoepidemiology studies to characterise and quantify product risks.
  • Lead multidisciplinary Safety Management/Safety Review Teams to drive signal evaluation, surveillance strategies, and risk mitigation recommendations.
  • Be accountable for the medical and scientific quality of aggregate safety reports, Pharmacovigilance Plans/RMPs, Investigator’s Brochures, and safety sections of regulatory submissions.

Skills

Pharmacovigilance leadership
Signal detection
Regulatory submissions
Team leadership

Education

MD/DO degree

Tools

MedDRA
PV databases

Job description

Immunocore is seeking a Senior Director, Global Pharmacovigilance (Safety Physician) to lead medical safety strategy for development and marketed products. The role oversees signal detection, regulatory submissions, and risk management, guiding a team of PV physicians and safety professionals across the product lifecycle.

This senior medical leader will interact with global Health Authorities, shape PV plans, and ensure high-quality safety reporting and lifecycle safety management for complex

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