Executive Director, Drug Safety Surveillance
About the Company
Pioneering biopharmaceutical company specializing in RNA-targeted drug discovery
Industry
Biotechnology
Type
Public Company
Founded
1989
Employees
501-1000
Categories
Specialties
Business Classifications
About the Role
The Company is seeking an Executive Director for Drug Safety Surveillance. The successful candidate will be responsible for providing safety science and pharmacovigilance support across the entire portfolio, with a focus on signal detection activities for both pre- and post-marketed products. This includes the review and evaluation of aggregate safety data, coordination of safety review meetings, and the production of various safety-related documents. The role also involves strategic planning and oversight of vendors, collaboration with Drug Safety Physicians on proactive risk management, and ensuring the timely delivery of safety regulatory documents. The Executive Director will be a key player in the company's mission to revolutionize drug discovery and transform the lives of patients with unmet medical needs. Applicants must have a Master's degree in life sciences with a minimum of 12 years' experience in pharmacovigilance, or a Doctorate with at least 8 years' experience in a pharmaceutical or biotechnology setting. A solid understanding of US and ex-US pharmacovigilance regulatory requirements is essential, as is experience in pre- and post-approval pharmacovigilance activities. The role requires strong clinical knowledge, analytical skills, and proficiency in communication. The ideal candidate will be able to work independently, manage work priorities, and build collaborative team relationships. Responsibilities also include mentoring safety surveillance scientists, monitoring industry best practices, and participating in cross-functional projects to ensure adequate safety support.
Hiring Manager Title
Vice President and Head of Drug Safety/Pharmacovigilance
Travel Percent
Less than 10%
Functions
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