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 https://www.jnj.com

Job Function:
Product Safety

Job Sub Function:
Product Safety Risk Management MD

Job Category:
Scientific/Technology

All Job Posting Locations:
Lisbon, Portugal

Job Description:

Johnson & Johnson is recruiting for a Medical Review Safety Physician Manager to be located in Lisbon, Portugal. 

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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.

Responsibilities include, but are not limited to the following:


* 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)


* Acti...