Director of Pharmacovigilance Operations and Partnerships
7 days ago
About Daiichi Sankyo, Inc.
">Daiichi Sankyo Group is a leading pharmaceutical company dedicated to creating innovative therapies to improve global healthcare standards. With over 125 years of scientific expertise and a presence in over 20 countries, our team of 18,000 employees worldwide strives for excellence in oncology research and development.
Job Description:
">We are seeking an experienced Director of Pharmacovigilance Operations and Partnerships to lead the development and management of local and global strategic partnerships and contracts. This role requires a deep understanding of pharmacovigilance regulations and practices, as well as excellent leadership and communication skills.
Responsibilities:
">- PV Agreements and Contracts: Lead PVA/SDEA management, oversee PV relevant contracts, and collaborate with legal and PV functions to develop contract templates.
- Strategic Partner Management: Establish and maintain relationships with key stakeholders, provide PV oversight of call centers and ICSR processing activities, and manage vendor assessments.
- PV Regulatory Intelligence: Oversee PV regulatory intelligence activities, monitor and track regulatory trends, and facilitate CSPV requests for regulatory intel.
Qualifications:
">- A minimum of 5 years of professional management experience in pharmacovigilance required
- 10+ years of drug safety/pharmacovigilance experience, including both investigational and marketed products required
- Knowledge of adverse event and drug coding conventions (MedDRA, WHO-DD)
- Familiarity with FDA and global PV regulations, clinical and safety databases
- Master's degree in a related field preferred
Salary Estimate:$120,000 - $180,000 per year
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