Location: West London
Reference: PW 6685
Closing Date: 21 Nov 16
Salary (£): Competitive
Benefits: Full Benefits including Bonus / Car / Pension / Private Medical / Life Assurance
Founded in 1906, Norgine is the “Go To” specialist European pharmaceutical company. They are focused on the development, manufacturing and marketing of medicines for important areas of healthcare. Norgine believes that there are attractive opportunities to develop innovative products which not only improve patient care but also can be proven to add economic value to the overall healthcare system. They focus on three core areas, gastroenterology, hepatology, critical and supportive care. Collaboration, a dedication to working with each other, and their stakeholders is a way of life for Norgine. Inventiveness, flexibility and teamwork are at the heart of what they do, it’s what makes Norgine different.
HQ based in UK
Office based role / M4 M40 Corridor – West London
As Senior PV Physician you’ll provide leadership and, in collaboration with GPV Lead Team, take responsibility for maintaining efficient and compliant operational drug and device safety processes and systems, meeting applicable global legal and regulatory requirements.
Accountable for the benefit risk product profiles of delegated products, both pre and post marketing, including signal detection, evaluation, benefit risk review of aggregate safety reports, Risk Management Plans, product safety labelling and implementation of resulting PV recommendations, authoring of expert advice and statements & oversight of those undertaken by members of staff in training.
Coordinate, manage and oversee the production of RMPs to ensure they are produced in line with SOPs, quality standards and timelines.
Oversight of the review and medical assessment of ICSRs, periodic safety reports, risk management plans and reflection of emergent safety data in product labelling.
Provide expertise and support for urgent safety reviews and competent authority RFIs for products including issues relating to product quality. Provide input into the creation and maintenance of pharmacovigilance processes and procedures, documented in company Standard Operating Procedures, Guidelines and User Manuals. Contribute to their effective implementation through targeted training activities.
Support regulatory inspection and internal quality audits by contributing to inspection preparedness and acting as subject matter expert for defined PV processes.
Provide leadership and oversee training and development of junior PV physicians and other GPV staff.
Support affiliates and PV responsible staff in delivery of local pharmacovigilance activities.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Medical qualification. Further qualification in pharmaceutical medicine preferred, but not essential.
Significant experience in pharmaceutical/biotech industry or CRO with specific experience of pharmacovigilance.
Good knowledge of relevant global pharmacovigilance and device requirements for post marketing and development product safety.
Excellent knowledge of the European regulatory environment for both pre- and post-marketing product safety.
Sufficient experience in PV systems to ensure the integrity of systems, particularly in the areas of risk management and signal detection.
Experience in clinical development safety and previous experience of supporting QPPV responsibilities advantageous.
Previous management/ leadership experience desirable.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to firstname.lastname@example.org quoting reference PW 6685.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk
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Richmond upon Thames,
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