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Director, Safety Surveillance Physician, Team Lead
Requisition ID: 0689180301
Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Director, Safety Surveillance Physician Team Lead. This position will be based in Horsham, PA (preferred), Titusville, NJ or Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The objective of this position is to provide therapeutic area medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes oversight of signal detection activities at the single case level, single case medical review, vendor oversight, and management of surveillance physicians. The Team Lead SSP will report to the Head of MSSI and will ensure communication of potential single case medical review quality, compliance and signal management issues when appropriate.
The Director, Safety Surveillance Physician Team Lead (Director TL, SSP) has additional responsibilities to those of the Director, SSP in that the TL will lead a group of physicians who are responsible for single case signal detection and the medical evaluation of adverse event data according to international regulation and company SOPs. The Director TL, SSP will be responsible for assuring that the workload is appropriately assigned and that output meets quality standards and will also be responsible for leading collaborative interaction within the Global Medical Safety Operations (GMSO) and the Medical Safety Assessment (MSA) Groups. The Director TL, SSP is expected to play a greater role as a senior technical leader and when required, to provide guidance to SSPs in evaluating safety issues/signals in collaboration with the Medical Safety Officers. The medical expertise of the Director TL, SSP will be reflected in activities such as managing product area or project team, participating on cross-functional teams such as SOP committees, taskforces, work streams etc. and representing GMS positions, processes and guidance to external business partners.
- Direct, supervise and provide leadership to the Safety Surveillance Physicians for JnJ products under GMS responsibility. Assign workflow as appropriate to assure compliance with timelines.
- Oversee quality of output for single case signal detection activities preparation of individual case safety reports (ICSRs) including Watch Lists, PSUR, PADER, and product quality complaints.
- Ensure Product Teams are set up as needed and oversee that the meetings meet the standards of the MSSI group
- Ensure active participation of SSP in Safety Management Teams (SMT)
- Provide therapeutic area/Pharmacovigilance issue guidance in the context of Leading/managing a product team.
- Provide leadership in single case assessment and mentoring of new SSPs.
- Lead collaboration within GMS. The collaboration must focus on ensuring that SSPs successfully leads GMS product teams, participate in cross functional therapeutic area teams as medical subject matter experts. The SSP must function as a medical subject matter expert on safety issues/signal detection in the Safety Management Teams, as well as leading the GMS Product Teams. Participate in cross-functional activities, e.g. GMSO, MSA, IPV collaborations.
- Oversee all aspects of medical evaluation of adverse event reports, including but not limited to all serious and expedited reports.
- Provide medical and patient safety support to therapeutic team for pre- and post-marketing programs
- Review, provide input and approve all SUSARS/AOSI prior to regulatory submission
- Participate in vendor oversight by ensuring that SSP conduct quality vendor review for assigned products and escalate issues as appropriate. Provide training and knowledge transfer as required and develop a working relationship aligned within the governance framework.
- Lead projects and processes of technology and scientific innovations for the Medical Safety Surveillance and Insight (MSSI) group.
- Physician (MD or equivalent) with a minimum of 5 years of substantial Pharmaceutical Industry experience and a minimum of 2 years of post-graduate training is required
- A minimum of 2 years of Pharmacovigilance experience is required
- Board Certified/Board Eligible/equivalent is preferred
- Significant skills in clinical medicine and PV, including experience in post-marketing safety assessments is required
- Proven track record in dealing with difficult safety issues, clinical safety data, and strong collaborative and networking skills is required
- Proven leadership skills and management experience in supervising a group of employees is preferred
- Ability to influence, negotiate and communicate with both internal and external customers is required
- Ability to develop, implement, communicate and influence policy and strategy internally and externally to the company is required
- Ability to work in a global, team-oriented, matrixed environment is required
- Ability to present complex data in a concise and understandable scientific manner is required
- Knowledge of Good Clinical Practices and PV regulatory requirements is required
- Working knowledge of the use of Microsoft suite of software products including Excel and Word is required
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Drug & Product Safety Science