- Entry level
- No Education
- Salary to negotiate
The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-prescription pharmaceutical products.
Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences. To support our Worldwide Research & Development operation, we are building a complex R&D support center in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.
Deputy Qualified Person for Pharmacovigilance
Location: Warsaw, Poland
Full time permanent contract
The Deputy QPPV Consumer collaborates with and supports the QPPV Consumer in providing guidance and oversight to ensure that MAHs in Europe are compliant with the requirements of EU legislation. Provides expert guidance to the Operating Companies and other business stakeholders on PV requirements.
You will have the following areas of responsibility:
Supports and collaborates with the EU QPPV Consumer regarding:
Accountability for the performance and maintenance of the PV systems for consumer products including oversight of the relevant key performance indicators
Oversight of the production and maintenance of the PV System Master File (PSMF)
Acting as the back-up in the absence of the QPPV for both internal and external contacts for products marketed in the EEA
Review of aggregate reports and risk management plans required for submission in the EEA and other countries
Provision of expert guidance to the Operating Companies and other business stakeholders on PV requirements and processes as defined in appropriate legislation and Company Standard Operating Procedures
The Candidate will need to:
Keeps him/herself actively up to date and contribute to risk minimization activities, all safety-related issues regarding the medicinal products portfolio including any arising issues from (post-marketing) clinical studies and research related activities, in particular oversight of PASS.
Work together with the EEA QPPV Consumer on strategic and Subject Matter Expert input into company decision making structures
Qualifications and experience of the successful candidate:
Medical degree preferred but not required; public health, pharmacoepidemiology, bioscience degree or related disciplines
Post-graduate training and/or ample work experience in clinical research, regulatory, pharmacovigilance and risk management (regulatory agency or industry). At least 4 years’ experience in the pharmaceutical industry preferred.
Regulatory experience in industry or a main Health Authority in the EEA.
Expert knowledge of the European Laws and regulations relevant to pharmacovigilance
Unique opportunity to become part of a global consumer healthcare market leader
Versatile and fulfilling role in a dynamic and international corporation
Work in a supportive and highly professional team
Further opportunities for professional development and career growth
Motivating financial remuneration & numerous employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.