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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: Belgrade, Serbia
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. With a global presence across Europe, North America, and Asia, PrimeVigilance delivers expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. The company partners with pharmaceutical and biotech clients of all sizes and covers all therapy areas, including medical devices. PrimeVigilance fosters a people-first culture that emphasizes professional growth, well-being, and work-life balance.


Job Responsibilities:

  • Review and approve post-marketing ICSRs and SAEs from clinical trials, ensuring medical and causality assessments are complete.

  • Perform assessments including seriousness, coding, causality, listedness/expectedness, and follow-up queries.

  • Serve as or support the Qualified Person for Pharmacovigilance in the evaluation of safety issues.

  • Review and contribute to aggregate safety reports such as PSURs and DSURs.

  • Develop and assess literature screening strategies and evaluate safety-relevant articles.

  • Participate in the preparation and evaluation of Risk Management Plans.

  • Support responses to regulatory authority inquiries.

  • Contribute to signal detection and benefit-risk evaluations, including line listing reviews and signal detection reporting.

  • Provide expert consultation to clients regarding risk minimization and benefit-risk assessments.


Required Qualifications:

  • Medical degree (qualified physician)

  • Proven experience in pharmacovigilance activities

  • Expertise in reviewing aggregate reports such as PBRERs and DSURs

  • Experience in signal detection and evaluation processes

  • Strong communication and presentation skills

  • Fluent in English (spoken and written)

  • Proficient with MS Office tools

  • Exceptional organizational and prioritization capabilities

  • Strong cross-cultural and cross-functional collaboration skills


What We Offer:

  • Internal training and career development opportunities

  • Strong focus on personal and professional advancement

  • Supportive and inclusive global team environment

  • English as the working language across regions

  • A culture rooted in diversity, inclusion, and shared success


Core Values:

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships