Job Description

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:

Lisbon, Portugal

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 as assigned

• Additional ad hoc activities that may require physician input, examples:
  • Standard Operating Procedures (SOPs)
  • CAPAs
  • Audits/inspection activities

• 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.

• Lead cross functional projects/teams, as assigned.

Minimum Qualification

• 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 ability to effectively communicate with internal and external customers.
• Fluent in written and spoken English.
• Working knowledge of the use of Microsoft suite of software products, including Excel and Word.

Required Skills:

Preferred Skills:

Clinical Operations, Compliance Management, Compliance Risk, Critical Thinking, Cross-Functional Collaboration, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Tactical Planning, Team Management

The anticipated base pay range for this position is:

€50,500.00 - €86,365.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information:

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 interview process that is inclusive of our applicants’ needs. 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 contact AskGS to be directed to your accommodation resource.