Senior Pharmacovigilance (PV) Scientist

About This Role:
As a Senior Pharmacovigilance (PV) Scientist, you will play a pivotal role as a product lead within the Safety team, overseeing and spearheading critical PV activities. Your responsibilities encompass managing the safety signal process, authoring aggregate reports like PSURs and DSURs, and addressing safety inquiries from both internal and external stakeholders. You'll delve into medical and scientific literature to extract vital safety information while supporting Clinical Trial PV medical activities. Collaborating with the Associate Director, you will also hire, train, and mentor staff dedicated to product-specific tasks. Your role as a Subject Matter Expert ensures compliance with global safety regulations and guidelines, fostering data analysis and product information sharing across cross-functional teams. This position is vital for maintaining the integrity and continuity of clinical trials and marketed products, ensuring they meet regulatory standards globally.

This is hybrid role requiring a minimum of 50% on site office attendance per week in Maidenhead.

What You'll Do:

• Lead the signal management process, including signal detection, documentation, and safety risk decisions for assigned products.
• Author signal evaluation reports and manage literature review for safety information.
• Respond to safety questions from regulatory authorities and lead Aggregate Report management.
• Finalize aggregate safety reports such as PSURs, DSURs, REMS, and RMPs for assigned products.
• Collaborate with Global Safety Officers and Safety MDs on investigational programs, including clinical trial activities and safety committee management.
• Manage data analysis, signal detection, and product activities as assigned.

• Bachelor's Degree in biologic or natural science, or health care discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required.
• Significant and proven Pharmacovigilance experience, including aggregate safety reports and safety signal management.
• Experience leading and conducting projects related to signaling and regulatory agency requests.
• Ability to interpret, analyze, and present scientific and medical data clearly.
• Strong foundation in Pharmacovigilance and drug development, including knowledge of safety regulations.
• Proficiency in common data processing software (Excel, PowerPoint, Microsoft Word).
• Leadership skills and collaborative interaction in team environments, internally and externally.
• Strong organizational skills with the ability to prioritize independently.

• Knowledge of common safety database systems.
• Experience in interacting with cross-functional teams such as Clinical Development and Regulatory.