Full-Time PV Physician II
Ergomed is hiring a remote Full-Time PV Physician II. The career level for this job opening is Experienced and is accepting Pune, India based applicants remotely. Read complete job description before applying.
Ergomed
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Job Details
Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports.
Review includes:
- Coding
- Seriousness assessment
- Company causality and comment
- Listedness/expectedness
- Follow-up questions
Act as a Qualified Person for Pharmacovigilance or support the Qualified Person.
Review and provide input in:
- Periodic Safety Update Reports
- Development Safety Update Reports
- Literature screening search strategy
Review articles to determine if they contain ICSRs/SAEs.
Cooperate in preparation of and provide input in Risk Management Plans.
Support the preparation of responses to regulatory authority requests.
Signalling:
- Reviewing line listings
- Participating in signal detection activities
- Writing signal detection reports (if applicable)
- Consultation to clients on benefit/risk assessment and risk minimization
Evaluate and categorize possible signals.
Support preparation and review of benefit-risk reports.
Essential Skills & Experience:
- Medically qualified physician
- Previous experience in pharmacovigilance
- Review different aggregate report types (PBRERs, DSURs)
- Expertise in signal detection
- Excellent interpersonal skills
- Planning, organizing, prioritizing, and executing multiple tasks
- Effective cross-cultural and cross-functional teamwork
- Advanced communication and presentation skills
- Advanced English (spoken and written)
- Advanced MS Office literacy