Job Title: Senior PV Physician I
Location: Remote
Employment Type: Full-time
Department: PV Medical Group
About the Company:
PrimeVigilance, a part of the Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. With consistent global growth, our teams span across Europe, North America, and Asia, delivering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We support pharmaceutical and biotechnology partners of all sizes and cover all therapy areas, including medical devices. PrimeVigilance fosters a culture rooted in well-being, personal development, and a balanced work-life approach.
Job Responsibilities:
Review and approve post-marketing ICSRs and SAEs for medical and causality assessments, including seriousness, listedness, coding, company causality, comments, follow-up queries, and Analysis of Similar Events (AoSE).
Act as or support the Qualified Person for Pharmacovigilance (QPPV) on medical safety issues.
Review and approve literature screening strategies and assess safety-relevant articles.
Provide input and review Risk Management Plans (RMPs).
Lead or support the preparation of regulatory responses.
Review and contribute to periodic safety reports including PSURs, DSURs, PBRERs, PADERS, and ASRs.
Act as Company Lead for specific PV areas, such as developing the Company Core Data Sheet (CCDS).
Participate in signal detection activities: meetings, report review, and client consultations on benefit-risk assessments and risk minimization strategies.
Mentor and train junior PV Physicians.
Required Qualifications:
Medical degree (qualified physician)
Proven pharmacovigilance experience
Proficient in aggregate report types (e.g., PBRERs, DSURs)
Strong expertise in signal detection activities
High-level interpersonal and communication skills
Skilled in task prioritization and cross-functional collaboration
Presentation proficiency
Fluent in English (spoken and written)
Advanced proficiency in MS Office
What We Offer:
Internal training and structured career development opportunities
Emphasis on both personal and professional growth
A welcoming and supportive global work environment
Opportunity to collaborate with colleagues worldwide in an English-speaking ecosystem
Core Values:
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Gujarat :
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Canada |Quebec :
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Japan | Saitama |Tokyo :
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