Pharmacovigilance Scientist - Zug, Schweiz - Swisslinx

Swisslinx

Geprüftes Unternehmen

Zug, Schweiz

vor 3 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

On behalf of our client, an international Biotechnology company based in Baar, Swisslinx is looking for a PV Scientist/Senior PV Scientist.

This is a contract initially for 12 months (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.

Start date: As soon as possible (latest in January 2024)
Duration: 12 months
Extension: possible
Work location: Baar
Workload: 100%
Hybrid work (remote and on site)

Your mission:

Lead or support 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 evaluate safety data and signals as part of ongoing pharmacovigilance activities. Include synthesis of data from multiple sources and authoring signal evaluation reports. Lead signaling review process and product Safety Signaling Team meetings. Manage literature review for safety information.
Lead or support process for responding to safety questions from regulatory authorities.
Lead or support 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).
Collaborate 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.

Your profile:

Bachelor's Degree in biologic or natural science; or health case discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required
Minimum 47 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
Lead and conduct, 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 postmarketing 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.
Demonstrate leadership and interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
Strong organizational skills, including the ability to prioritize independently with mínimal supervision.