Medical Review Safety Physician - Manager (Oncology)

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:
Lisbon, Portugal

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 as well as operational aspects of individual case medical review.

The Medical Review Safety Physician (MRSP) manager has 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, MRSPs 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/PADERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.



* Active participation in MRSP activities which include, but are not limited to:



* Analysis and assessment of Critical Cases, including SUSARs


* Detection of single case potential safety signals/ through validation


* Identification and analysis of new safety signals and trends by conducting systematic reviews of aggregate data.


* Review local literature for potential signals assessed by vendors and Local Management Safety (LMS)


* Active participation in Signal Evaluation


* Ensuring Follow-up of all critical case/ Events of Special Interest (RMPs identified risks)


* PBRER/PADER activities


* Investigator Brochure activities


* Watchlist/TFUQ activities


* Vendor oversight activities...