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Senior Pharmacovigilance Physician I

2+ years
Not Disclosed
10 April 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Pharmacovigilance Physician I
Location: Remote
Employment Type: Full-time
Department: PV Medical Group


About the Company:

PrimeVigilance, part of the Ergomed Group, is a specialized mid-size pharmacovigilance service provider, established in 2008. The company has grown organically year after year, with teams based in Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance has become a global leader, providing expert support to pharmaceutical and biotechnology partners. The company is committed to investing in its staff by offering excellent training and development platforms. PrimeVigilance prioritizes employee well-being, work-life balance, and mental health, creating a nurturing environment that delivers high-quality client service.


Job Responsibilities:

  • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment in clinical trials

  • Act as a Qualified Person for Pharmacovigilance (QPPV) or assist the QPPV in evaluating safety issues when not medically qualified

  • Review and contribute to Periodic Safety Update Reports (PBRER), Development Safety Update Reports (DSUR), and literature screening strategies

  • Review scientific articles for ICSRs/SAEs or other safety findings related to the relevant Medicinal Product

  • Contribute to the development of Risk Management Plans

  • Support responses to regulatory authority requests

  • Participate in signal detection activities and provide consultation on benefit/risk assessments and risk minimization

  • Evaluate and categorize possible signals and propose actions

  • Review and support the preparation of benefit-risk reports


Required Qualifications:

  • Medically qualified physician

  • Previous experience in pharmacovigilance

  • Expertise in reviewing various aggregate reports such as PBRERs and DSURs

  • Strong experience in signal detection activities

  • Excellent interpersonal and communication skills

  • Ability to manage multiple tasks effectively, prioritize, and organize work

  • Strong cross-cultural and cross-functional collaboration skills

  • Advanced proficiency in English (both spoken and written)

  • Advanced literacy in MS Office


What We Offer:

  • Internal training and career development opportunities

  • Emphasis on personal and professional growth

  • A friendly and supportive work environment

  • Opportunity to work with global colleagues, with English as the company language

  • A company culture built on core values:

    • Quality

    • Integrity & Trust

    • Drive & Passion

    • Agility & Responsiveness

    • Belonging

    • Collaborative Partnerships