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Drug Safety Physician
6 days ago
Drug Safety Physician role.
Attached is the JD for your reference.
Experience required: 0 - 2 years
Qualification requirements: MBBS or MD
Vacancies: 5 Work
Location: Chandigarh Office
Job responsibilities:
- Providing medical advice to PV Scientists to assist them with processing of ICSRs
- Review of published literature articles/abstracts
- Performing additional drug safety related activities, as assigned
- Medical review of ICSRs for marketed and investigational human and veterinary products, ensuring accurate capture of safety data within patient narratives and critical data fields which impact medical evaluation (i.e. seriousness, causality, expectedness assessment, MedDRA coding)
- Interacting with internal or external contacts to resolve issues related to the assigned work
- Contributing (authoring and/or medical review) to aggregate reports like Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Addendum to Clinical Overview (ACO), Internal Periodic Safety Review (IPSR), Risk Management Plans (RMPs)] or other scheduled or unscheduled reports, as required
- Drafting Analysis of Similar Events (AOSE) summary for Serious Unexpected Suspected Adverse Reactions (SUSARs)
- Be well versed with safety profile of assigned drugs, labelling documents, client procedures and international drug safety regulations
- Maintaining current knowledge of applicable global regulatory guidelines
- Performing Signal Management activities that includes Signal Detection, Validation, Prioritization, Analysis & Assessment Company
- Job Types: Full-time, Permanent
**Salary**: ₹100,000.00 - ₹1,200,000.00 per month
Schedule:
- Day shift
- Monday to Friday
- Weekend availability
**Education**:
- Bachelor's (preferred)
**Experience**:
- Physician: 1 year (preferred)
Work Location: In person
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