Senior PV Scientist I - #46559

The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.

The Senior PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information. In this capacity, the Sr. PV Scientist is critical to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.

Key Responsibilities:

• Leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
• Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
• Leads process for responding to safety questions from regulatory authorities.
• Leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
• Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.

Essential Skills and Qualifications Required:

• Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
• Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
• Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.
• Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business
• Objects). Knowledge of common safety database systems.
• Demonstrates leadership and interacts collaboratively and effectively in a team environment (including
• Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with externa colleagues
• Applies clinical judgment to interpret case information.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision

Education and Experience Requirements for Job:

• Education bachelor’s degree in biologic or natural science; or health case discipline and/or advanced degree (PhD, MPH, NP, PharmD, etc.) required dependent on experience.
• Experience Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.

If you are interested, please apply with a copy of your CV. For our Global Pharmaceutical client based in Baar, Zug we are looking for a Senior Pharmacovigilance Scientist for a 12 months contract with extension possibilities.