Johnson & Johnson is recruiting for a Medical Director, Medical Safety and Benefit-Risk Oversight, QPPV Office, to be located in High Wycombe, UK.
Other EMEA locations may also be considered.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
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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/ .
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Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
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The Qualified Person responsible for Pharmacovigilance (QPPV) is a mandatory role and is responsible for the establishment and maintenance of the Marketing Authorisation Holder's pharmacovigilance (PV) system and must also have oversight over the functioning of the system, including its quality systems, safety database and product safety profiles (as defined in the European Medicines Agency's 'Guideline on good pharmacovigilance practices (GVP) Module I - Pharmacovigilance systems and their quality systems').
The Medical Director, Medical Safety and Benefit-Risk Oversight is part of the QPPV Office and reports to the QPPV.
The holder of this role supports the QPPV through the activities outlined below: Product Safety Profile and Risk Management Oversight (for assigned Therapeutic Areas): * Provide input into discussions on emerging safety concerns at relevant forums.
* Contribute to the preparation of regulatory actions in response to emerging safety concerns.
* Provide strategic medical and regulatory input to product teams and Risk Management Scientific Leads during the preparation of core and EU Risk Management Plans (RMPs).
* Provide guidance to Safety Management Teams (SMTs) during the preparation of responses to high-profile requests (such as Referral procedures) from National Competent Authorities (NCAs) and the European Medicines Agency (EMA) for information necessary for the benefit-risk evaluation of a medicinal product.
* Through involvement in the above activities, maintain oversight of the formal documentation of any conditions or obligations adopted as part of the MAs and other commitments relating to safety or the safe use of the products, risk minimisation measures, and PASS requested by a NCA (including the results of such studies).
Benefit-Risk Oversight: * Engage with key functional stakeholders to optimize the provision of oversight and key metrics for the performance of activities to monitor the benefit-risk profiles of the company's authorized products.
* Evaluate the provisions for meeting PV obligations within Post Authorisation Safety Studies (PASS) protocols that require approval by the QPPV, and the status of such studies.
* Maintain oversight of compliance with the requirements of regulatory authority Assessment Reports for PBRERs/PSURs.
Management/Mentoring Activities: * Direct management responsibilities may be assigned as required within the organizational requirements of the QPPV Office.
Miscellaneous: * Participate in internal and external groups for networking, intelligence gathering and input, as agreed with the QPPV Pharma.
* Support the QPPV and Deputy QPPV(s) with regard to issues related to medical safety and benefit-risk oversight, including audits and inspections.
* Engage with the relevant functions in the management of key regulatory actions related to post-authorization PV, as required.
* Perform related duties as assigned by supervisor.
* Maintain compliance with all company policies and procedures.
Minimum Qualification: * Medical Degree with medical practice experience; experience in internal medicine, public health, pharmacoepidemiology, or related disciplines preferred * Ability to evaluate, and experience of implementing, global PV regulatory requirements * Post-graduate training and/or ample work experience in pharmacovigilance and risk management (regulatory agency or industry), with good understanding of and experience in addressing medical safety issues in development and post-authorization arenas * Experience in identifying safety signals and management of safety issues * Knowledge of the European and United Kingdom laws and regulations relevant to pharmacovigilance and experience of operating in the context of global pharmacovigilance requirements.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
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 .