We are PrimeVigilance, a pharmacovigilance service provider, seeking a PV Physician to review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports.
Requirements
- PV Physician
- Review and approve post-marketing ICSR and SAE reports
- Act as a Qualified Person for Pharmacovigilance
- Review and provide input in Periodic Safety Update Reports
- Review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
- Participate in signal detection activities
- Evaluate and categorize possible signals and propose a course of action
- Support preparation and review of benefit-risk reports
- Medical qualification as a physician
- Previous experience in pharmacovigilance
- Ability to review different aggregate report types
- Expertise in signal detection activities
- Excellent interpersonal skills
- Ability to plan, organise, prioritise and execute multiple tasks
- Ability to work effectively cross-culturally and cross-functionally
- Communication skills
- Presentation skills
- English - advanced (spoken, written)
- Japanese - advanced (spoken, written)
- Advanced literacy (MS Office)
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world
