Medical Director
1 day ago
Cpl Healthcare is seeking a highly skilled Medical Director, Global Drug Safety and Pharmacovigilance to join our team.
Duties and Responsibilities
The ideal candidate will be responsible for implementing and coordinating safety surveillance procedures for products. This includes:
- Developing and leading safety activities and benefit-risk strategies throughout the life-cycle for assigned products in post-marketing, clinical development or both.
- Oversight, preparation, contribution, and/or review of aggregate safety review documents (e.g., DSUR, PBRER), PSMF and selected clinical documents including regulatory filings and risk management plans.
- Lead evaluation and management of signals emerging from any data source.
- Develop strategy for signal evaluation.
- Prepare and Review Signal Evaluation Reports (SERs) and ad hoc regulatory responses.
- Presentation of safety signals to development team and Global Safety Committee.
- Responsible for the medical review of all sources of safety information including ICSRs, product complaints, and requested medical information queries for assigned products.
- Contribute to safety labelling activities for products and ensure safety labelling adequately reflects emerging post marketing safety profile.
- Provide medical support to the EU QPPV or other regional or local Qualified Person for PV relative to issues relating to assigned products.
- Provide support to clinical development teams regarding emerging benefit-risk profile, appropriate safety monitoring during clinical trials and safety strategy for drugs in development.
- Lead medical safety oversight of and execution of risk management strategies and RMP elements for assigned projects.
- Act as safety lead on assigned projects with Business Partners, Vendors, Clinical Development Teams and Post Marketing Project Teams and in interactions with Medical Monitors and other personnel.
- Participate in company initiatives as a drug safety representative.
- May oversee activities delegated to other personnel.
- Mentor junior drug safety personnel, including drug safety scientists.
- Participate as required in internal audits and Health Authority inspections.
- Maintain current knowledge and understanding of regulations, ICH guidelines and industry practices in relation to pharmacovigilance.
- Attend product team meetings as needed, safety team meetings, company safety governance meetings, and regulatory interactions.
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