Position Medical Review Safety Physician Manager Lisboa

Position: Medical Review Safety Physician Manager

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

Our expertise in Innovative Medicine is informed by patients, and our teams work on developing medicines of tomorrow. Learn more at https://www.jnj.com/innovative-medicine

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.

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
- clinical studies, literature reports and other sources of safety data. MRSPs participate in matrix management activities (e. g. , Safety Management Team) 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;
- hoc regulatory reports; Risk Management Plans; and interpretation of surveillance and product quality data.

Responsibilities

• 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
  - up of all critical case/Events of Special Interest (RMPs identified risks)
• PBRER/PADER activities
• Investigator Brochure activities
• Watchlist/TFUQ activities
• Vendor oversight activities as assigned
• Ad hoc activities that may require physician input, including:
• Standard Operating Procedures (SOPs)
• CAPAs
• Audits/inspection activities
• Participation in pharmacovigilance
  - teams (e. g. , Safety Management Teams)
• Support GMS Product Team to drive change, increase efficiency, effectiveness and quality, and foster alignment across GMS and with key stakeholders
• Lead
  - functional projects/teams as assigned

Requirements

• 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 minimum of 3 years of experience in industry, academia, or patient care settings is required
• Direct experience in pharmacovigilance is strongly preferred
• Experience and knowledge of Good Clinical Practices is strongly preferred
• Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external customers
• Fluent in written and spoken English
• Working knowledge of Microsoft Office (Excel and Word)

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or Ask
GS for guidance.