Description: Under the close supervision of the Group Lead or Team Lead:
Support PV product responsible teams and participate in development core teams and core medical teams.
Conduct ongoing monitoring and assessment of the safety profile of assigned developmental and marketed products as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Phase 1 Phase 3 clinical trials and Post-Authorization Studies.
Perform timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator s Brochure and local product labeling.
Contribute to the design of safety surveillance strategies and manage safety signals for drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs).
Support risk management of assigned drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders.
Create regulatory reports and analytical papers, gathering and categorizing data, providing initial medical analysis and/or overall benefit/risk.
Create, or assist in creating:
PBRERs, DSURs, PADERs
Signal detection activities
Create and/or review safety portions of submission documents
Ability to participate in bridging communications between business and Medical Safety to ensure appropriate safety context is conveyed.
Coordinate, monitor and assess the safety profile of one or more specific products assigned to the Global TA under supervision of the TA group lead or TA team lead.
Bachelor' s degree in a scientific, health-related field
At least 3 years of hands on PV experience in clinical and/or post marketing
Solid understanding of regulations impacting Pharma industry in the US and globally, especially drug safety/ PV
Hands on experience writing/reviewing Aggregate Reports, e.g., PBRERs, DSURs, and PADERs
Hands on experience with signal detection activities such as analyzing/categorizing/
Strong leadership skills
Excellent oral and written communication skills
Excellent listening and comprehension skills
Ability to work effectively in a matrix setting to resolve issues and achieve common goals