Pharmacovigilance Operations Manager
6 days ago
Deciphera Pharmaceuticals is seeking a highly skilled Senior Manager, Pharmacovigilance Operations to join our team. This key leadership role will provide direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Deciphera Pharmaceuticals Clinical Trials and post marketing (where applicable).
Key Responsibilities- Pharmacovigilance Operations: Provide oversight and management of pharmacovigilance activities, including adverse event case management, safety reporting, and risk management.
- Vendor Management: Manage vendor relationships, including coordination of day-to-day operational activities, review of incoming adverse events, and oversight of vendor case processing and submission activities.
- Training and Development: Facilitate training for vendor personnel, including training on GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures.
- Safety Database Management: Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from Deciphera Pharmaceuticals clinical trials.
- Signal Detection and Management: Perform safety monitoring and signal detection activities, including signal identification, evaluation, interpretation of safety signals, and prioritization of signals for full evaluation and communication of safety risks.
- Regulatory Compliance: Ensure compliance with regulatory requirements, including reporting of adverse events to regulatory agencies, and maintenance of current knowledge of regulatory safety reporting guidelines.
- Education: Bachelor's/Advanced degree in life science, nursing, pharmacy, or other healthcare-related profession.
- Experience: 6+ years of direct pharmacovigilance work experience in the pharmaceutical industry, with experience with Argus Safety database and ICSR submission.
- Skills: Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements, knowledge of MedDRA and WHO Drug dictionaries, and experience with overseeing and managing vendors.
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