Global Medical Safety Physician Fellow

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Clinical Development & Research – MD

Job Category:
Scientific/Technology

All Job Posting Locations:
Lisbon, Portugal

Job Description:

Johnson & Johnson is recruiting for a Global Medical Safety Physician Fellow.  This position will be located in Lisbon, Portugal.

The Global Medical Safety Physician Fellowship is an 18 month  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 certifications of any kind.

Principal Responsibilities:


* Participate and complete training in several areas of pharmacovigilance, which include the following: safety surveillance and signal evaluation; identification of new potential safety concerns; characterization of emerging and known product safety profiles; the design and implementation of risk minimization strategies.


* Provide medical expertise in the evaluation of safety data from a variety of sources (interventional and non­interventional 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 (2) presentations concerning Pharmacovigilance and/or pertinent medical topics to your team.


* Provide assistance in the Medical Affairs team's activities concerning pharmacovigilance, quality, and regulatory affairs.


* Assist in the planning and execution of Medical Affairs activities, both in-office and ...