Vice President, Head of Drug Safety
About the Company
Innovative biopharmaceutical company
Industry
Pharmaceuticals
Type
Privately Held
About the Role
The Company is in search of a VP, Head of Drug Safety to provide both strategic and operational leadership for all clinical safety and post-market pharmacovigilance activities. The successful candidate will be responsible for ensuring the safety of products throughout their lifecycle, in compliance with global regulatory requirements and organizational objectives. Key responsibilities include leading the drug safety team, overseeing the collection, analysis, and reporting of adverse events and safety data, and collaborating with cross-functional teams to maintain product safety. The role also involves staying abreast of the latest pharmacovigilance regulations, working with CROs to ensure compliance, and driving the production and submission of periodic regulatory documents. Applicants must have a minimum of 15 years' experience in PV and drug safety, with at least 5 years in a leadership role, and possess a strong knowledge of global clinical trial and PV regulations. The role requires an understanding of all components of PV throughout a product's lifecycle, a thorough knowledge of the clinical development process, and the ability to work collaboratively in a cross-functional team environment. Experience in managing a high-performing team, excellent communication and interpersonal skills, and the ability to prioritize and deliver high-quality work within deadlines are essential. The VP, Head of Drug Safety will also be involved in the development of standard operating procedures related to drug safety and will support global regulatory submissions for new products, formulations, or indications.
Travel Percent
Less than 10%
Functions
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