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Director, Pharmacovigilance and Drug Safety Operations Leader
hace 1 mes
We are seeking a highly experienced Director, Pharmacovigilance and Drug Safety to join our team. This critical leadership role will be responsible for establishing, maintaining, and overseeing procedures and systems to ensure adherence to local and international regulatory requirements for the collection, processing, and reporting of safety information throughout the product life cycle.
Key Responsibilities:- Lead the Pharmacovigilance Operations & Compliance team in ensuring compliance with worldwide regulations, safety reporting to RAs, Investigator/ECs, and Business Partners.
- Develop and maintain SOPs, Wis, and controlled governing procedural guidance documents in collaboration with other functions, including CROs and vendors as applicable.
- Collaborate with safety physicians and other members of DSPV, clinical data management, biostatistics, safety vendors, and others as appropriate in developing the strategy for safety data review and for preparing safety data outputs.
- Contribute to the preparation and review of responses to health authority queries, as well as the assembly and production of aggregate safety reports.
- Lead the GSDB implementation & maintenance activities, including validation, data migration, and associated change management actions.
- Master's degree in a relevant field (Life sciences), nursing degree, or pharmacy degree required.
- A minimum of 8-10 years of experience in pharmacovigilance with a focus on operations, across development and post-marketed phases.
- 3 years of experience working with and providing oversight to PV vendors and/or hosting partners.
- 3 years of experience leading people or teams.
- Prior experience in GSDB implementation, validation, and data migration is required.
- A competitive base salary range of $210,000 to $239,400 USD.
- A comprehensive Total Rewards program, including base salary, target bonus, and stock options, as well as a full range of benefits.
- Opportunities for professional growth and development, including a Tuition Assistance program for advanced degrees.
Xenon Pharmaceuticals is an equal opportunity employer and welcomes applications from diverse candidates. We thank all applicants for their interest; however, only those chosen for interview will be contacted.
