Global Lead Pharmacovigilance 100% (a)

The Senior PV Scientist acts as the global lead for Pharmacovigilance activities within the Safety department, overseeing PV Scientist(s) assigned to their designated products. The responsibilities will be around the following task areas :

• Leading the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s)
• Evaluating the safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports
• Leading the signaling review process and product Safety Signaling Team meetings as well as cross functional project meetings
• Leading the process for responding to safety questions from regulatory authorities
• Providing strategic input to the authoring of regulatory documents such as PSURs, DSURs, PADERs, Addendum to Clinical Overview
• Leading the development of Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs) including providing safety input to post authorization safety studies (PASS) and additional risk minimization measures
• Leading the development of the strategy for medical and scientific literature review for safety information
• Providing safety leadership to regulatory submissions in collaboration with the Global Safety Officer
• Maintaining an up to date understanding of relevant global safety regulations and guidelines
• Collaborating 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
• Leading initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions

In order to be considered for the role, the selected candidate must have :

• Master degree or degree in Life Sciences or related field
• 8+ years work experience in PV incl. strong experience in safety signal management and aggregate safety reports
• Strong pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations
• Ability to work with complex clinical data to produce robust assessments of safety data
• Familiarity of pharmacoepidemiology definitions and their use in pharmacovigilance is desirable for working with safety science research activities
• Knowledge of common data processing software as well as of common safety database systems
• Strong written communication skills in English

The selected candidate will be part of a dynamic team and actively contribute to the discovery, development and delivery of innovative therapies to improve the lives of patients.