Qualification: M. Pharm / B. Pharm / BAMS / BHMS / BDS (Health care qualified)
Location: Mumbai
Experience:
- 2 to 3 years of experience in drafting and reviewing of PADER, PSUR, PBRER and RMP.
Job Responsibilities:
- Preparation and quality review of various types of Aggregate Reports (AR)-PSUR, PBRER, Annual Safety Report, PADER, RMP, etc.
- Strategizing for submission of ARs.
- Kick-off meeting arrangement with clients, and relevant stakeholders (ICSR team, etc.)
- Generate line listings and summary tabulations, referring to the processed ICSR for ARs and XML from a global safety database.
- Issue Identification and resolution.
- Support in other departmental activities.
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📌 Safety Medical Writer (India)
🏢 Fidelity Health Services
📍 India