Medical Review Safety Physician - Manager

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Product Safety Job Sub Function: Product Safety Risk Management MD Job Category: Scientific/Technology All Job Posting Locations: Taguig, National Capital Region (Manila), Philippines Job Description: Essential Job Duties and Responsibilities  The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes single case signal detection activities for selected products.   The Medical Review Safety  Physician (MRSP), at the Manila site has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data. Additionally, SSPs participate in matrix management activities (e.g. Safety Management Team (SMT)) and provide pharmacovigilance expertise on individual case reports. MRSPs support activities such as evaluating safety issues from various sources including Designated Medical Events (DME) and Events of Interest (EVOI), preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data. The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process; this includes single case signal detection activities for selected products.   Active participation in MRSP activities which include, but are not limited to: Analysis and assessment of SUSARs Analysis and assessment of Critical Cases Detection of single case signals/ through validation Member of Safety Management Team Active participation in Signal Evaluation Ensuring Follow-up of all critical case/ Events of Special Interest (RMPs identified risks) PBRER activities Investigator Brochure activities Watchlist activities   Identification and analysis of new safety signals and trends Review of Designated Medical Events (DMEs) and Event of Interests (EVOIs) for  potential signals, from the  DME and EVOI assessments coming from vendors. Review of potential signals from local literature assessed by vendors and Local Management Safety (LMS) Perform  validation of potential signals and coordinate with MSO.Prepare summary analysis of safety data for the SMTs. Provide recommendations for further evaluation.   Participation in  pharmacovigilance matrix-teams (i.e. Safety Management Teams) responsible for pharmacovigilance activities focused on products and therapeutic areas as assigned.   ·Support GMS Product Team to drive change, increase efficiency, effectiveness and quality, and foster alignment, across GMS and with key stakeholders.

Physician (MD or equivalent) with a medical degree from a recognized medical institution. A minimum of 1 year of clinical practice after postgraduate training program is preferred.. A