QPPV Office - Medical Advisor-00000GGR
Description
Janssen Research & Development - QPPV Office
Medical Advisor
At Janssen Research & Development, LLC, we are united and energized by one mission - to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time.
As one of the Janssen Pharmaceutical Companies, our strategy is to identify the biggest unmet medical needs and match them with the best science, internal or external, to find solutions for patients worldwide. We leverage our world-class discovery and development expertise, and operational excellence, to bring innovative, effective treatments in five therapeutic areas:
- cardiovascular and metabolism,
- immunology,
- infectious diseases and vaccines,
- neuroscience, and
- oncology.
We think of the world as our laboratory and we look for innovation wherever it exists. This drives our relentless search for the best science, and our pursuit of collaborations and partnerships.
We believe there are no limits to what science can do. And we never lose sight of those who rely most on our discoveries. Please visit www.jnjpharmarnd.com for more information.
An exciting new opportunity has arisen for a Medical Advisor within the QPPV Office of Janssen R&D. This role is an integral member of the QPPV team who are responsible for establishing and maintaining/managing the Marketing Authorisation Holder's pharmacovigilance system; as well as having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the Marketing Authorisation Holder holds authorisations.
The Medical Advisor will specifically be responsible for:
Establishing and maintaining the PV System
- Participating in internal and external groups for networking, intelligence gathering and input, as agreed with the QPPV
- Managing the QPPV Pharma group mailbox, taking action, referring and archiving as appropriate
- Acting as ambassadors for PV governance within and outside the company
- Acting as a back-up to the QPPV for safety governance issues, including audits and inspections
Overview of safety profiles and emerging safety concern
- Maintain an awareness of developments in the safety profiles of the Pharma products in the relevant Therapeutic Areas (TAs) and Established Products (EP) area, as assigned, and act as a back-up to fellow QPPV Medical Advisors for other TAs
- Engage with the relevant functions in the development and review of key regulatory documents related to PV for products in the TAs and EP area, as assigned
- Review and input to the design, and monitor the conduct, of Post-Authorisation Safety Studies
- Acting as a back-up contact point to the QPPV for all pharmacovigilance matters for Pharma products globally.
Acting as a single point of contact for Competent Authorities
- Be available as a back-up to the QPPV
Decision-making and Problem Solving
-
Support the QPPV Pharma in making decisions and recommendations to ensure MAHs in Europe are compliant with the requirements of Volume 9A Guidelines, and in ensuring that the Company has appropriate systems for pharmacovigilance compliance and product safety management globally.
- QPPV Medical Advisors are involved, where appropriate, in the development and review of key regulatory documents, such as PSURs and EU-RMPs, prior to approval by the QPPV.
- Working collaboratively with TA and EP Safety Heads, SMT Chairs, Regulatory Affairs leads, and systems and product QA leads to address and resolve issues relating to products and PV processes
Qualifications
The successful candidate will have:
- Medical Degree and GMC registration required
- Regulatory experience in industry or a main Health Authority in the EEA. Practical experience in pharmacovigilance in the pharmaceutical industry required; corporate awareness
- Post-graduate training and/or ample work experience in pharmacovigilance and risk management required (regulatory agency or industry)
- Specialisation in internal medicine, public health, pharmacoepidemiology, or related disciplines preferred
- Knowledge of the European laws and regulations relevant to pharmacovigilance and knowledge of global pharmacovigilance requirements
We respectfully request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Janssen-Cilag Ltd, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: Pharmacovigilance
Description
Janssen Research & Development - QPPV Office
Medical Advisor
At Janssen Research & Development, LLC, we are united and energized by one mission - to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time.
As one of the Janssen Pharmaceutical Companies, our strategy is to identify the biggest unmet medical needs and match them with the best science, internal or external, to find solutions for patients worldwide. We leverage our world-class discovery and development expertise, and operational excellence, to bring innovative, effective treatments in five therapeutic areas:
- cardiovascular and metabolism,
- immunology,
- infectious diseases and vaccines,
- neuroscience, and
- oncology.
We think of the world as our laboratory and we look for innovation wherever it exists. This drives our relentless search for the best science, and our pursuit of collaborations and partnerships.
We believe there are no limits to what science can do. And we never lose sight of those who rely most on our discoveries. Please visit www.jnjpharmarnd.com for more information.
An exciting new opportunity has arisen for a Medical Advisor within the QPPV Office of Janssen R&D. This role is an integral member of the QPPV team who are responsible for establishing and maintaining/managing the Marketing Authorisation Holder's pharmacovigilance system; as well as having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the Marketing Authorisation Holder holds authorisations.
The Medical Advisor will specifically be responsible for:
Establishing and maintaining the PV System
- Participating in internal and external groups for networking, intelligence gathering and input, as agreed with the QPPV
- Managing the QPPV Pharma group mailbox, taking action, referring and archiving as appropriate
- Acting as ambassadors for PV governance within and outside the company
- Acting as a back-up to the QPPV for safety governance issues, including audits and inspections
Overview of safety profiles and emerging safety concern
- Maintain an awareness of developments in the safety profiles of the Pharma products in the relevant Therapeutic Areas (TAs) and Established Products (EP) area, as assigned, and act as a back-up to fellow QPPV Medical Advisors for other TAs
- Engage with the relevant functions in the development and review of key regulatory documents related to PV for products in the TAs and EP area, as assigned
- Review and input to the design, and monitor the conduct, of Post-Authorisation Safety Studies
- Acting as a back-up contact point to the QPPV for all pharmacovigilance matters for Pharma products globally.
Acting as a single point of contact for Competent Authorities
- Be available as a back-up to the QPPV
Decision-making and Problem Solving
-
Support the QPPV Pharma in making decisions and recommendations to ensure MAHs in Europe are compliant with the requirements of Volume 9A Guidelines, and in ensuring that the Company has appropriate systems for pharmacovigilance compliance and product safety management globally.
- QPPV Medical Advisors are involved, where appropriate, in the development and review of key regulatory documents, such as PSURs and EU-RMPs, prior to approval by the QPPV.
- Working collaboratively with TA and EP Safety Heads, SMT Chairs, Regulatory Affairs leads, and systems and product QA leads to address and resolve issues relating to products and PV processes
Qualifications
The successful candidate will have:
- Medical Degree and GMC registration required
- Regulatory experience in industry or a main Health Authority in the EEA. Practical experience in pharmacovigilance in the pharmaceutical industry required; corporate awareness
- Post-graduate training and/or ample work experience in pharmacovigilance and risk management required (regulatory agency or industry)
- Specialisation in internal medicine, public health, pharmacoepidemiology, or related disciplines preferred
- Knowledge of the European laws and regulations relevant to pharmacovigilance and knowledge of global pharmacovigilance requirements
We respectfully request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Janssen-Cilag Ltd, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization: Janssen Cilag Ltd. (7360)
Job Function: Pharmacovigilance