Johnson & Johnson is recruiting for a Medical Safety Officer, Vaccines, to be located in Lisbon, Portugal.
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The Pharmaceuticals Medical Safety Officer (MSO) is a physician with training or experience in medical safety, who reports into the Global Medical Safety 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 within the Vaccine Therapeutic Area (TA). 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 TA. The MSO will help ensure communication of potential and known risks, when appropriate, to the TA Safety Head, the Head of Global Safety Strategy and Risk Management (GSSRM), the Chief Safety Officer (CSO), the Pharmaceuticals Chief Medical Officer (CMO), the Qualified Person for Pharmacovigilance (QPPV) Pharma, 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 Johnson & Johnson products.
Duties and 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 Clinical 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 Pharmaceuticals 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
- Provide Lead or actively participate in department-wide initiatives
- Support to other active products within the TA as needed
Education and Experience:
- Medical degree from a recognized medical institution. Board Certified/Board Eligible preferred;
- A minimum of 2 years of pharmacovigilance experience or other relevant experience preferred (e.g. Clinical research, Medical Affairs, Public Health, etc...)
- Medical specialization preferred
- Vaccine Therapeutic Area experience 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
- Ability to influence, negotiate and communicate with both internal and external customers
Required Technical Knowledge and Skills:
- 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, 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
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .