Manager, Pharmacovigilance - Oncology Princeton, New Jersey @Orchard LLC, has been retained by a fast growing bio-pharmaceutical firm, with a sole focus on Oncology research and development, to assist in building an exceptional team of experienced professionals. Currently we have an opportunity to satisfy for a Manager, Pharmacovigilance (PV) in support of the PV Physicians, providing surveillance and risk management capabilities. This is an exceptional opportunity for an experienced PV Professional to really have impact and enjoy a great quality of life, working for a firm that truly looks after its people. From competitive compensation to fully funded healthcare and 401k matches, our client is committed to supporting the great people of their team with an exceptional environment, while their product pipeline is very exciting, pointing to longevity and security. Our client is a wholly-owned subsidiary of a global pharmaceutical powerhouse and works urgently to discover and develop innovative cancer treatments.
As cancer evolves, our client evolves with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower them to redefine the way the world treats cancer. The Manager with the PV physician(s) on all aspects of medical surveillance and risk management activities for assigned investigational and marketed products. Works cross-functionally with internal and external key stakeholders, Clinical, Regulatory, Medical Affairs and external resources on pharmacovigilance-related matters.
The nature of the therapeutic pathway means that the assigned work is a consistently complex and challenging nature and scope. Are you ready to; Partner with PV physicians, providing medical surveillance and risk management activities for assigned products or therapeutic area? Author and compile pharmacovigilance aggregate reports (e.g. DSUR, PBRER, topic reports) for all Company products?Collaborate with PV physicians and key stakeholders to request/receive applicable sections of the report. Provide training and guidance to other functions to address ad hoc questions and issues. Ensure timely submission to relevant health authorities and other external stakeholders. Provide safety information as needed for study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling for assigned products? Collaborate with the PV physicians to ensure all information is available to allow for informed medical review and benefit-risk assessment of assigned products? Contribute to safety surveillance and signal detection activities for assigned products or therapeutic area? Ensure that routine Global Safety Product Committee (GSPC) meetings are in place for assigned products and share best practices?Schedule and coordinate meetings. Ensure appropriate stakeholder representation and input per GSPC SOP. Liaise with GSPC chair to facilitate communication and support for decisions resulting from the GSPC (e.g. update of RMPs, labeling, regulatory notifications). Support the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for assigned products? Collaborate with internal and external stakeholders outside of PV and represent the PV department in cross-functional meetings and additional activities to support assigned clinical developmental programs? Maintain a thorough understanding of all clinical and post-marketing activities and PV requirements for assigned products? Participate in audit preparedness activities and serve as subject matter expert during regulatory inspections in collaboration with team members? Participate in new study initiation to ensure PV requirements are met including but not limited to: safety reporting, query resolution, SAE reconciliation, un-blinding process, and safety reporting training? Provide expertise by guiding, training, and overseeing pharmacovigilance vendor supporting pharmacovigilance activities? Lead internal PV meetings (Product Meeting, Process improvement meeting, etc.) based on assigned products? Provide training and mentorship to PV Scientists? Your background will like; College degree in life science or health related or pharmaceutical field, or the equivalent.
Advanced qualifications such as RN, R.Ph, or PharmD, strongly preferred. Minimum 4 years’ experience in Pharmacovigilance environment and with a minimum of 2 years’ experience in a PV Scientist/Sr. PV Scientist role managing adverse events processing on a global basis. Knowledge of ICH/FDA guidelines for GCP and Clinical Safety Reporting. Extensive working knowledge of medical dictionary of regulatory activities (MedDRA). Experience with the use of global safety databases is required. Experience leading safety data review meetings, creating agenda and meeting minutes. Experience leading SAE reconciliations. Experience authoring aggregate reports Ability to effectively present information to internal and external clients. If your experience and interests align with this role, and you want to align your career with a stable and growing firm with an excellent pipeline of products within Oncology, then we need to hear from you. Please apply. Established in 2010, Talent Orchard has an exceptional reputation, providing staffing solutions to time-sensitive, talent scarcity issues to deliver better talent management ROI.
Our specialty lies in the critical area of program talent acquisition and resource management, not in one narrow skillset, but across many areas of technical and functional delivery. To learn more about our other exciting opportunities, visit our Jobs Page at www.talentorchard.com.