Instagram
youtube
Facebook

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 achieved global organic growth year after year, with staff based across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-lasting relationships and becoming a global leader in its field. The company covers all therapy areas, including medical devices.

PrimeVigilance is dedicated to investing in its employees by providing excellent training and development opportunities. The company values employee well-being, mental health, and work-life balance, which are critical to ensuring 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, including coding, seriousness, causality, listedness/expectedness, and follow-up questions

  • Act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance in evaluating safety issues

  • Review and provide input on Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and literature screening search strategy

  • Review articles to identify ICSRs/SAEs or other safety findings related to medicinal products

  • Cooperate in preparing and providing input on Risk Management Plans

  • Assist in preparing responses to regulatory authority requests

  • Participate in signal detection activities, including writing reports and consulting clients on benefit/risk assessment and risk minimization

  • Evaluate and categorize potential safety signals and propose actions

  • Support the preparation and review of benefit-risk reports


Required Qualifications:

  • Medically qualified physician

  • Previous experience in pharmacovigilance

  • Expertise in signal detection activities is essential

  • Ability to review various aggregate report types, including PBRERs and DSURs

  • Strong interpersonal skills

  • Ability to plan, organize, prioritize, and execute multiple tasks

  • Effective cross-cultural and cross-functional collaboration skills

  • Strong communication and presentation skills

  • Advanced proficiency in English (spoken and written)

  • Advanced MS Office literacy


What We Offer:

  • Training and career development opportunities internally

  • Strong emphasis on personal and professional growth

  • Friendly, supportive working environment

  • Opportunity to collaborate with colleagues across the globe, with English as the company language


Core Values:

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships