Senior PV Physician
Work Model: Remote
Employment Type: Full-time
Department: PV Medical Group
Company: PrimeVigilance (Ergomed Group)
Company Overview
PrimeVigilance, part of the Ergomed Group, is a mid-size global pharmacovigilance service provider established in 2008. With teams across Europe, North America, and Asia, the company delivers high-quality solutions in:
Pharmacovigilance
Medical Information
Regulatory Affairs
Quality Assurance
PrimeVigilance emphasizes employee development, mental well-being, and work–life balance, supporting a culture that drives long-term success and exceptional client service.
Role Summary
The Senior PV Physician is responsible for the medical evaluation of safety data from both post-marketing and clinical trial settings. The role involves reviewing ICSRs and SAEs, evaluating safety signals, and supporting QPPV activities while ensuring compliance with regulatory and internal standards.
Key Responsibilities
1. Medical Review & Safety Assessment
Review and approve post-marketing ICSRs, including seriousness, expectedness, coding, and company causality assessment.
Review and approve Serious Adverse Event (SAE) reports from clinical trials.
Prepare company medical comments, follow-up questions, and Analysis of Similar Events (AoSE).
Complete all required supporting documentation, including trackers and logs.
2. Support to QPPV
Provide medical insights and support to the Qualified Person for Pharmacovigilance (QPPV) on safety issues.
Assist with evaluating emerging safety concerns and regulatory expectations.
3. Literature & Safety Signal Review
Assess scientific/medical articles for ICSRs, SAEs, or other safety-relevant findings.
Review safety-related database outputs and analyses.
4. Cross-Functional Collaboration
Collaborate effectively with global PV, regulatory, and medical teams.
Engage in team meetings, presentations, and cross-functional discussions as required.
Qualifications
Required
Medical qualification (MD/Physician).
Ability to work effectively across cultures and in collaborative, global teams.
Strong presentation and communication skills.
Advanced English proficiency (spoken and written).
Strong MS Office proficiency.
Why PrimeVigilance?
Growth & Development
Structured internal training and career development opportunities.
Strong focus on personal and professional growth.
Work Culture
Supportive, friendly, and collaborative work environment.
Opportunities to work with colleagues globally (English is the company language).
Commitment to diversity, equity, inclusion, and a people-first approach.
Core Values
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Join Our Mission
Become part of a team committed to improving patient safety worldwide. PrimeVigilance looks forward to receiving your application.
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