Title: Senior Medical Director-Pharmacovigilance Region: Mid-Atlantic Specialty: PHARMACOVIGILANCE Function: DRUG SAFETY Degree: MA Salary: 0+ Description: Client is a leader in the discovery and development of innovative medicines utilizing next-generation antibody-based technologies. The team of 350+ employees advances a pipeline of product candidates for cancer treatment. The company's products and platforms have attracted partnerships with leading pharmaceutical and biotech firms worldwide. The company values its employees highly and promotes opportunities for professional growth. Its culture fosters innovation, open communication, and teamwork, allowing employees to see how they contribute to organizational success. Summary of Position: The Senior Medical Director for Pharmacovigilance monitors and manages the safety profile of investigational and marketed products. Responsibilities include reviewing and analyzing drug safety data, identifying safety signals, and establishing benefit-risk profiles. The role serves as the medical safety advisor throughout the product lifecycle, escalating safety concerns as per governance policies and keeping leadership informed. The position requires minimal supervision. Responsibilities and Job Duties: Conduct safety surveillance across the product lifecycle, reviewing clinical trial and post-marketing safety reports, including AEs, SAEs, and product complaints. Identify emerging safety issues. Analyze safety data from clinical and post-marketing sources, communicate signals, and collaborate with PS Specialists on analysis and follow-up activities. Work with Clinical Development and Operations teams to ensure safety data accuracy and quality in clinical trials. Lead or contribute to clinical trial safety monitoring, including laboratory data review. Evaluate safety data and author safety statements for study protocols, CSR, IB, investigator communications, aggregate reports, CCDS, and product labels. Ensure timely review of ICSRs, assess safety narratives, coding, and causality, and escalate concerns as needed. Contribute to Risk Management Plans and REMS. Perform aggregate safety data reviews to detect signals and develop risk mitigation strategies, escalating issues per policies. Apply knowledge of local and global regulatory guidelines. Mentor junior drug safety physicians as appropriate. #J-18808-Ljbffr