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Senior Pharmacovigilance Scientist Leader
1 week ago
We are ADC Therapeutics America Inc, a global leader in the field of antibody-drug conjugates (ADCs). Our team is passionate about developing innovative treatments that make a difference in the lives of patients worldwide.
We are seeking a talented Director, Pharmacovigilance Scientist to join our Global Drug Safety function. As a member of our team, you will play a key role in supporting the safety strategy and requirements for our assigned drug project(s).
As a Director, Pharmacovigilance Scientist, you will lead PV scientist activities, develop and execute comprehensive safety surveillance and signal detection plans, and author safety sections for regulatory documents. You will work closely with cross-functional teams, including GSP, Clinical, and Regulatory Affairs.
Main Responsibilities
- Leads PV scientist activities of cross-functional project teams for developmental compounds and/or marketed products.
- Works collaboratively with the GSP to develop, maintain, oversee, and execute the comprehensive safety surveillance and signal detection plan for assigned products.
- Authors and contributes safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents, and Clinical Study Reports.
- Leads the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
- Authors and provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
- Authors and provides strategic leadership to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Why Work with Us
- We offer a dynamic and supportive work environment that fosters growth and development.
- We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.
- We provide opportunities for professional growth and development, as well as competitive compensation and benefits.