Senior Pharmacovigilance Scientist - RA Manager Level 3

Job content

Do you want to work in a biotech company? Do you have at least 5 years experience in Pharmacovigilance? You should then read the following lines!

Our client, based in Baar, is looking for a Senior Pharmacovigilance Scientist for a contract until 28.02.2023

Your 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.
  

Your Profile

• Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
• 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 external colleagues
• Applies clinical judgment to interpret case information.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision
  

Do not waste any minutes, apply now! We are looking forward to receiving your application.

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.