Full-Time Senior PV Physician I
Ergomed is hiring a remote Full-Time Senior PV Physician I. The career level for this job opening is Senior Manager and is accepting Pune, India based applicants remotely. Read complete job description before applying.
Ergomed
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Review and Approve ICSRs and SAEs: Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports from clinical trials for medical/causality assessment. Review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
Qualified Person Support: Act as a Qualified Person for Pharmacovigilance or support the Qualified Person in medical understanding and evaluation of safety issues.
Periodic Safety Reports: Review and input in Periodic Safety Update Reports, Development Safety Update Reports, and literature screening search strategy.
Literature Review: Review articles to identify ICSRs/SAEs related to the medicinal product or other safety findings.
Risk Management Plans: Cooperate in the preparation of Risk Management Plans and provide input.
Regulatory Authority Requests: Support preparation of responses to regulatory authority requests.
Signal Detection: Review line listings, participate in signal detection activities (meetings, reports), and consult clients on benefit/risk assessment and risk minimization.
Signal Evaluation: Evaluate and categorize possible signals, propose a course of action.
Benefit-Risk Reports: Support preparation and review of benefit-risk reports.
Medical Qualification: PV Physician must be medically qualified as a physician.
Pharmacovigilance Experience: Previous experience in pharmacovigilance is required.
Report Review Expertise: Ability to review different aggregate report types (PBRERs, DSURs).
Signal Detection Expertise: Expertise in signal detection activities is essential.
Interpersonal Skills: Excellent interpersonal skills.
Time Management: Ability to plan, organize, prioritize, and execute multiple tasks.
Cross-Cultural Teamwork: Ability to work effectively cross-culturally and cross-functionally, valuing teamwork.
Communication and Presentation Skills: Strong communication and presentation skills.
English Proficiency: Advanced English (spoken and written).
Computer Skills: Advanced literacy in MS Office.