Job Description: Summary
The Manger, Pharmacovigilance Alliance for BD's Global Medical Safety organization guides and facilitates effective relationships between global Pharmacovigilance (PV), other BD functions partnering with PV, vendors and external business partners who utilize BD drug /combination products as part of their products or offerings. The incumbent will work with BD's Law Group and contracting to create and manage the process of Safety Data exchange agreements with our external vendors to ensure the smooth, accurate, and timely flow of critical safety and other Pharmacovigilance data and ensure appropriate agreements for new business partners related to safety data and PV.
Responsible for global PV SDEA activities. Serve as the liaison between BD global PV and associated business partners or vendors.
Support business partners in onboarding for new partnerships and maintenance of the agreements with current and new partners.
Manage the safety/ PV onboarding process, establishing SDEAs/PVAs with business partners for new products.
Interact with business partners for additional information to address questions in establishing SDEA/PVA, as well as request safety information to support PV efforts.
Coordinate the SDEA/PVA review by the PV review team, summarize agreement comments, and participate in the negotiation of the agreement.
Contribute to resolving conflicts at team level or higher and facilitate decision making within the team.
Assist in educating/serve as a resource to the Global PV Department. Support in/out-licensing activities.
Collaborate with the cross-functional groups that have responsibility of associated business partners' activities within BD such as (but not limited to) Clinical Development, Regulatory Affairs, Clinical Operations, Quality Assurance, Legal, and Project Management.
Organize and moderate meetings and author minutes'/discussion summaries for PV related activities. Solicit items for and set agendas. Send out draft minutes/summaries for comments to both internal Global PV and associated business partners, and distribute final summaries to all participants, as well as global PV department. Follow up with meeting participants on the resolution of action items from meetings. Maintain and organize internal Project management files (business partners agreements, supporting documents, meeting agenda/minutes).
Participate in maintaining PV Agreements Database/Portal and Mailbox.
Initiate/Develop/Review/Update departmental procedural documents such as SOPs and Training Guidance. Collaborate effectively with authors, reviewers, approvers, and trainers.
Support audit and inspection activities as needed.
Assist with project management activities for the PV department.
Experience: The following listed requirements need to be met at a minimum level to be considered for the job:
3+ years' experience in the Pharmaceutical Industry, with at least 3 years of PV experience working with SDEAs
Experience working with partners and distributors.
Experience with global drug safety / PV regulations (i.e., FDA, EMA, MHRA, Bfarm, etc.) and working in a global pharmaceutical drug safety department.
Knowledge of GMP, ICSR Reporting, Periodic Safety Reports (PADER, DSUR, PSUR / PBRER).
Project management experience.
Experience with process improvement initiatives.
Demonstrated ability to influence without authority
Demonstrated capability in conflict management, project management and negotiating skills
Strong oral and written communication skills (seems to me like this is a must)
Strong leadership skills a must
Comfortable and capable of utilizing software programs such as:
Excel, Word, and PowerPoint
Primary Work Location
USA NJ - Franklin Lakes
BD (Becton, Dickinson And Company)