Senior PV Scientist

Overview

In this Senior PV Scientist role, you will lead pharmacovigilance activities for assigned products and act as a product lead within Safety. You will oversee signal management, literature reviews, and aggregate safety reports to support regulatory compliance and product safety. You will collaborate with senior leaders to mentor staff and guide cross-functional teams on global safety regulations. The position offers meaningful scope in safeguarding clinical trials and maintaining product marketing authorizations.

Responsibilities

• Conduct ongoing safety data reviews and signal detection as part of pharmacovigilance oversight
• Lead signal management for assigned products, including evaluation, documentation, and leading Safety Signaling Team meetings
• Manage literature reviews to identify relevant safety information
• Oversee aggregate report management (PSURs, DSURs, RMPs) and related safety documents
• Prepare scientifically robust responses to safety questions from regulatory authorities
• Collaborate with Global Safety Officers and Safety MDs to support investigational programmes and safety committee management
• Manage ad hoc safety data analyses and information requests with timely outputs

Key requirements

• Advanced degree (PhD, MPH, NP, PharmD, etc.)
• Significant pharmacovigilance experience including aggregate safety reports and safety signal management
• Proficiency in interpreting, analyzing, and presenting scientific and medical data
• Strong foundation in pharmacovigilance and drug development, including regulatory safety knowledge
• Basic knowledge of data processing software (Excel, PowerPoint, Word, Business Objects) and safety database systems
• Demonstrated leadership and collaborative skills within teams

• leadership
• collaboration
• organizational skills
• pharmacovigilance
• signal management
• literature review

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