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Johnson & Johnson is recruiting for a Medical Safety Officer. This position will be located in Lisbon, Portugal.

The Manager, Medical Safety Officer (MSO) is a physician with training or experience in medical safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of products or product families and the reasonable mitigation of risk associated with such products.

The MSO will lead the safety assessment of assigned marketed drugs. The MSO will help ensure proactive and timely assessments of safety data to characterize the emerging and known safety profiles of the products within the Therapeutic Area (TA). The MSO will help ensure communication of potential and known risks, when appropriate, to TA Safety Head, Chief Safety Officer (CSO), Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV), Senior Management, Health Authorities

(HA), prescribers and/or patients. In compliance with legal and regulatory requirements, the MSO will also contribute to and supervise, when appropriate, the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Innovative Medicine products.

Responsibilities include but are not limited to the following:

• Provide medical expertise to the GMS TA and provide medical oversight to non-physician GMS staff including:

  • Defining the safety question or issue requiring medical safety assessment

  • Developing the strategy for aggregate safety reports, risk management plans, safety reviews and analyses

  • Interpreting results and determining the medical importance of question or issue

  • Reviewing and approving (i.e., signatory) for medical assessment reports, e.g., ad hoc safety reports

• Provide end-to-end safety support and surveillance, including active participation in delisting or divesting activities.

• Chair multidisciplinary Safety Management Teams (SMT) for assigned products whose responsibilities include safety surveillance (including signal detection) and risk management activities [including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)], as well as other activities related to managing the safety profile of assigned products.

• Participate on TA Compound Development Teams (CDTs) and Clinical Teams (CTs) as deemed necessary by the TA Safety Head.

• Effectively communicate medical safety and risk management evaluations as necessary to the CMO, the GMS Senior Leadership Team, and the Medical Safety Council (MSC).

• Participate in HA interactions regarding safety and risk management, both written and verbal.

• Provide input, review, and approval of key safety, regulatory or clinical documents as appropriate, to ensure these key safety documents are of high medical and scientific quality. These might include:

  • Clinical Trial Protocols

  • Safety Sections of Investigator’s Brochure (IB) and IB addenda

  • Clinical Study Reports (CSR)

  • Annual Safety Reports (ASR)

  • Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for

  • NDA/BLA/MAA filings

  • Informed Consent Form Risk Template

  • Risk Management Plans

  • Periodic Benefit Risk Evaluation Report (PBRER) Safety Update Report (PSUR),

  • Development Safety Update Report (DSUR)

  • Health authority queries

  • Company Core Data Sheets (CCDS), US and EU prescribing information

  • Signal Evaluations

• Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.

• Assist in the creation, review, and implementation of new standard operating procedures (SOPs), Work Instructions, guidelines, documents, and other tools pertaining to safety assessment and risk management.

• Lead or actively participate in department-wide initiatives.

• Provide support to other active products within the TA as needed.

• Perform delegate responsibilities for other MSOs or SMT Chairs.

Qualifications:

• Medical degree from a recognized medical institution required.

• A minimum of 1-3 years of pharmacovigilance experience or other relevant experience preferred (e.g., Clinical research, Medical Affairs, clinical).

• Medical specialization preferred.

• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.

• Demonstrated basic knowledge of principles of drug development, pharmacology, assessment of drug risks and benefits, and safety assessment of drugs on the market and global safety regulations.

Required Technical Knowledge and Skills:

• Ability to influence, negotiate and communicate with both internal and external customers.

• Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc.), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.

• Ability to effectively lead global cross-functional teams.

• Connect, collaborate, and build consensus across relevant functions.

• Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, pharmacovigilance (PV) documents and risk management plans.

• Able to plan work to meet deadlines and effectively handle multiple priorities.

• Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable.

• Proficiency in Word and PowerPoint is desired.

• Fluent in written and spoken English.

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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.