Head of Safety
A clinical stage gene therapy company is looking for a Head of Safety to join its team in this newly created role. This organization focuses on treating Parkinson's and various other Neurodegenerative Diseases. In this role you will report into CMO and take full ownership of the PV function. As this company's products continue to advance in development you will also have the ability to build out a team in your own image!
The Head of Safety will be responsible for:
- Lead product safety surveillance strategy and activities for multiple investigational products during all phases of the product life-cycle
- Represent GDSP on the product program and clinical team(s)
- Represent GDSP at Data Monitoring Committee meetings
- Maintain knowledge of therapeutic area diseases and investigational products' safety and efficacy profile
- Ensure that routine signaling activities assessment and investigation are completed and documented per SOPs
- Respond to safety-related queries from regulatory authorities, IRBs/ECs
- Lead product benefit-risk assessment discussions at Safety Governance Committee
- Includes needed actions to update Reference Safety Information or risk minimization actions
- Lead Safety and Pharmacovigilance representation for clinical development across multiple investigational product(s) including:
- Clinical development plans, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis and reporting of study data
- Safety content of IB, Reference Safety Information, ICF
- Regulatory filings (ISS, Benefit-Risk, RMP/REMS)
- Responsible for medical-safety sections of aggregate safety reports (DSUR, PSUR)
- Conduct medical review of individual case safety reports (ICSRs)
- Includes appropriate follow-up requests and accuracy and timeliness of expedited reports
- Oversee CRO activities related to safety and pharmacovigilance
- Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations
Ideal Candidates will have:
- MD, or foreign equivalent.
- Minimum 8 years pharmacovigilance experience
- Neurology experience is nice to have, but not a must have.