Description
Carry out pharmacovigilance and risk management activities for specific product or products:- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
- Prepare and review periodic safety reports (DSUR, PSUR, EU Annual Safety Reports) in accordance with regulatory requirements and PDMS standard operating procedures
- Coordinate safety activities between PDS and internal and external partners
Carry out signal detection activities and evaluation:
- Conduct/support signal detection and evaluation according to SOPs and guidelines
- Carry out medical review of spontaneous case reports and Serious Adverse Event reports from clinical trials, according to SOPs and guidelines
- Prepare Drug Safety reports, as necessary, for potential signals
- Respond to queries relevant to the safety of products from the affiliates and other internal functions
Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:
- Provide review of clinical protocols and study reports to ensure alignment with CDP and safety adequately addressed, and contributes to the safety section of the Investigators Brochure (IB)
- Contribute to regulatory authority submissions (NDAs, MAAs, Variations) by reviewing safety data and preparing relevant sections of the submission
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