The Global Medical Safety Physician Fellowship is a one-year program designed to provide qualified physicians the opportunity to gain specialized and in-depth training in key areas of pharmacovigilance within the pharmaceutical industry.
This Fellowship does not provide certification of any kind.
The Global Medical Safety Physician Fellow (GMSPF) will:
- Participate and complete training in several areas of pharmacovigilance, which include: safety surveillance and signal evaluation; identification of new potential safety concerns; and characterization of emerging and known product safety profiles; and the design and implementation of risk minimization strategies.
- Provide medical expertise in the evaluation of safety data from a variety of sources (interventional and non-interventional clinical studies, post-marketing data, literature reports, and other sources of safety data) as part of the overall pharmacovigilance surveillance process; this includes medical review of individual case safety reports (ICSRs) and evaluation of aggregate safety data.
- Ensure communication of potential new safety concerns and trends to the Medical Safety Officer (MSO) and the Safety Management Team (SMT).
- Support SMT activities such as the evaluation of safety issues to characterize any emerging or known product safety profiles, preparation of aggregate safety reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), ad-hoc regulatory reports, and interpretation of surveillance and product quality data.
- Work in a cross functional, matrix team environment.
- Contribute to, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen Research & Development, LLC products.
- Provide two presentations concerning Pharmacovigilance and/or pertinent medical topics to your team.
Qualifications
- Candidates must have a Medical Degree (MD/DO or equivalent) with three or more years of clinical experience (residency training included) at the start of the program.
- Board certification/eligibility is preferred but not required.
- Candidates need to have the ability to critically evaluate data from multiple sources (clinical trials, literature, etc.), assess clinical importance and potential impact of the data, and present the findings clearly in both written and oral communications.
- Candidates need to be able to meet deadlines and effectively handle multiple priorities with excellent verbal and written communication skills, including formal presentation skills, fluent in written and spoken English, and a working knowledge of the use of Microsoft Office (including Excel, Word, and PowerPoint).
Locations: Horsham, Pennsylvania, Titusville or Raritan, New Jersey
Learn more and apply here.
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