Senior Aggregate Reports Project Manager
Edison-New Brunswick Metro Area, NJ
The Senior Project Manager will function as the overall project manager for the development and finalization of assigned key safety documents such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs). The individual will also maintain / manage agreement and contract updates related to drug safety vendors and support the logistical management of global safety governance escalation meetings including agenda creation with the application of good documentation practice.
Collaborates with internal and external stakeholders managing data information and exchange between all parties involved. Leads stakeholder meetings, troubleshoots and mitigates issues throughout the development process of each key deliverable.
Create and maintain the DSUR, PBRER and RMP development project schedules in compliance with global procedures and assign deliverables to key identified stakeholders.
Negotiate with appropriate stakeholders to ensure that DSUR, PBRER, and RMP commitments are met.
Work closely with Safety Medical Writer to develop DSURs, PBRERs, and RMPs, manage their review cycles, and ensure they are finalized in time for Health Authority submission.
Write certain sections of DSURs, PBRERs, and RMPs as needed.
Track activities in close collaboration with the Global Safety Team (GST), Safety Data Management (SDM), and Safety Medical Writer, ensuring the accurate inclusion of benefit-risk assessments and risk characterizations into DSURs, PBRERs, and RMPs.
Collaborates closely with Global Safety Team (GST) Chairpersons and Coordinators to manage and facilitate meeting logistics, documentation, and scheduling for multiple clinical safety project teams in a cross-functional environment
Maintain and manage agreement and contract updates related to drug safety vendors
Maintain working knowledge of company policies and assigned products as related to drug safety roles and responsibilities
Maintain working knowledge of document management system used to review and finalize key safety documents
Mentors junior PV personnel in their functions
Performs other departmental duties as assigned.
Minimum BA/BS in life/health sciences or related field
Advanced degree in life/health sciences or related field preferred
BA/BS with minimum 6 years of pharmaceutical industry experience in Drug Safety, directly handling activities of case processing and safety aggregate reports
Minimum of 2 years' experience in Drug Safety management
Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization.
Strong attention to detail
Strong analytical and problem-solving skills