Product Safety Risk Management Lead and Deputy QPPV
The Johnson & Johnson Group of Consumer Companies is recognized as a world leader in providing health and beauty products and solutions across Baby, Beauty, Healthcare and OTC medicines. The breadth and depth of our product portfolio is truly impressive and constantly expanding as we strive to bring science to the art of healthy living.
Each day, millions of people of all ages in homes around the world use products from one or more of our consumer healthcare companies. These products keep babies clean and comfortable, nourish and moisturise skin, prevent sunburn, hold allergy symptoms in check, help heal wounds, reduce fevers, and tame the urge to smoke.
Each one of our consumer health businesses embraces cutting-edge science to create products that are doctor-recommended, helping you and your family to be well and stay well. As a result, our consumer companies produce many of the world’s most trusted brands. Taking health and well being to the next level.
PRODUCT SAFETY RISK MANAGEMENT LEAD AND DEPUTY QPPV
Location: Warsaw Poland or other EEA country
Contract: full time
Product Safety Risk Management Lead and Deputy Qualified Person for Pharmacovigilance (QPPV) reports to the QPPV and primarily provides support in the oversight of the safety profiles and risk management of Johnson and Johnson Family of Consumer Companies (JJFCC) medicinal products licensed in the European Economic Area (EEA) and the United Kingdom (UK). Also cultivates knowledge of the functioning of the JJFCC PV System, including the related Quality System, and contributes to the global oversight of this system and maintenance of the PSMF for EU and UK.
As part of the pharmacovigilance system, the marketing authorization holder shall have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance in the European Union (QPPV) and in the UK (regulation inserted by the EU Exit Regulations 2019) and applicable guidance defining legal requirements for this position in the UK, NI and Great Britain.
The responsibilities & the impact YOU will have:
Product Safety Profile and Risk Management Oversight
Provide comprehensive review and assessment of PSURs, PBRERs, other aggregate safety reports or Ad hoc reports, and EU-RMPs prior to approval by the QPPV.
Provide input as needed to ensure new safety information from aggregate reports is handled appropriately
Participate on behalf of QPPV as a member of Safety Management Teams (SMT) for medicinal products or product families
Provide guidance to Safety Management Teams (SMTs) during the preparation of responses to Health Authority safety requests regarding information necessary for the benefit-risk evaluation of a medicinal product
Through review of EU-RMPs, maintain oversight of the formal documentation of any conditions or obligations adopted as part of the Marketing Authorizations and other commitments relating to safety or the safe use of the products, risk minimization measures, and PASS/PAES requested by a NCA, EMA and MRA MHRA (including the results of such studies)
Contribute to the preparation of regulatory actions in response to emerging safety concerns
Evaluate the provisions for meeting PV obligations within Post Authorization Safety Studies (PASS) protocols that require approval by the QPPV,
PV Quality System oversight
Maintain up to date knowledge of the functioning of the JJFCC PV Quality System and awareness of the PSMFs content for EU and UK
Contribute as needed to the maintenance of the PSMFs for EU and UK
Provide back-up to the QPPV in case of planned and unplanned absence
Participate in relevant internal and external groups for networking, intelligence gathering and input regarding product safety management, as agreed with the QPPV Pharma
Support the QPP for medical safety and risk management-related issues, including audits and inspections
Engage with the relevant functions in the management of key regulatory actions* related to PV, as required
Support the QPPV in making decisions and recommendations to ensure MAHs in Europe are aware of their obligations in relation to compliance with the requirements of EU PV Legislation regarding product safety management and PV quality system.
Working collaboratively with MSOs, Regulatory Affairs leads, and other functions as appropriate to address and resolve issues relating to product safety.
Providing appropriate PV guidance to key stakeholders in addressing issues related to PV Quality System Compliance
We would love to hear from YOU, if you have:
Life sciences degree, with Pharmacy or Medical (preferred) qualification (and experience of related practice) considered advantageous
Post-graduate training and/or ample work experience (at least 5 years) in regulatory agency or pharmaceutical industry, Clinical Research Organization).
Good medical/scientific judgement and the ability to analyze complex data to draw appropriate conclusions regarding product safety and benefit/risk, and to address specific safety-related regulatory challenges in collaboration with Regulatory and OCMS functions.
Good knowledge of EU PV legislation and guidance and experience, and understanding of the complexities of a PV System
Regulatory experience in industry or a main Health Authority in the EEA would be of value
Languages: Excellent written and spoken English required.
Good understanding of and experience in addressing product safety issues in development and post-authorization arenas
Knowledge of the European laws and regulations relevant to pharmacovigilance, drug development and knowledge of global pharmacovigilance requirements
Resident of the EEA country
This is what awaits YOU at J&J:
An opportunity to be part of a global market leader.
A dynamic and inspiring working environment.
Many opportunities to work on challenging projects and assignments.
Possibilities for further personal as well as professional development.
Many employee benefits.
Johnson & Johnson is an Affirmative Action andEqual Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, or national origin and will not be discriminated against on the basis of disability.
Poland-Mazowieckie-Warsaw- Other Locations
Netherlands, Slovakia, Czech Republic, Denmark, Lithuania, Italy, Latvia, Poland, Portugal, Romania, Slovenia, Sweden, Belgium, Bulgaria, Germany, Spain, Estonia, Finland, France, Greece, Croatia, Hungary, Ireland Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies