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.
#J-18808-Ljbffr