Safety Operations Director
3 weeks ago
About Us
We are a leading biopharmaceutical company committed to developing innovative treatments for patients with retinal disorders. Our proprietary drug delivery platform, Encapsulated Cell Technology (ECT), has shown promise in treating Macular Telangiectasia Type 2 (MacTel) and other chronic retinal diseases.
Job Summary
We seek an experienced Director of Pharmacovigilance Operations to lead our PV department and implement strategies ensuring compliance with adverse event collection and reporting requirements. This role will oversee case processing activities performed externally by vendors and provide operational management and oversight.
Main Responsibilities
- Develop and coordinate PV department procedures to ensure compliance with regulatory requirements.
- Manage all vendor-related activities, including scope of work, safety management plans, contracts, training, and oversight.
- Support and oversee vendor activity related to individual case safety reports (ICSR), aggregate reports, compliance metrics, and expedited reporting.
Requirements
- Bachelor's degree in pharmacy, nursing, medicine, or a related field; advanced degree preferred.
- Minimum 4 years of experience in pharmacovigilance, drug safety, or a related role within the pharmaceutical/biotech industry.
- Minimum 2 years managing PV vendors.
- In-depth knowledge of global pharmacovigilance regulations (FDA, EMA, ICH, GVP).
Estimated Salary Range: $130,000 - $160,000 per annum.
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