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Pharmacovigilance

medical director

Key/Main responsibilities: The Medical Director is a senior figure within a Pharma, Biotech or CRO organisation and is accountable for the medical leadership, governance, performance and culture within the company. This is achieved through developing and delivering an organisation-wide purpose and strategy, inspirational leadership, and the engagement of colleagues and customers.

As the Director of the Medical team, the role holder is responsible for effective delivery of the medical affairs, regulatory, quality, pharmacovigilance (PV) and medical information functions.

A Medical Director is responsible for regional Medical Plans and deliverables for the relevant therapy area and ensures that these plans are represented in Regional Medical Plans.

The Medical Director works in partnership with commercial teams and ensures medical alignment on key strategies, deliverables, & communication in the region. They will serve as a medical “champion” and act as an ambassador of the company with Global and colleagues in other affiliates as well as with customers, other external stakeholders and industry peers. The Medical Director will also serve as company representative in key regional forums and meetings and may be primary point of contact for scientific questions with regulatory authorities in the region. The Medical Director may be responsible for enquiries and communication regarding the regional medical aspects, such as regulatory submissions, vaccine safety aspects (PSUR, SAE reports), the local medical plan, IIR coordination and local review, medical support for the development of promotional documents and validation, development of stand-by statements, training materials, and objection handlers, medical support of advisory boards, support of local, regional and European congresses and symposia, medical support of publications and local competitive intelligence / competitive readiness.

The Medical Director will need to ensure high ethical standards are met and will likely have final signatory status therefore taking personal responsibility when declaring advertising / publication material meets all the MHRA requirements. The medical signatory will ensure that all the medical information included is accurate, fair, balanced and will not compromise patient safety in any way.

The Medical Director may also lead a team of medical and/or scientific advisors

Previous roles/experience would include: Medical Adviser, Senior Medical Adviser, Medical Manager, Associate Medical Director.

Usually reports into: Senior Medical Director, EU Medical Director, VP Medical Affairs. CEO, Managing Director, General Manager

Sits within this team: Medical Adviser(s), Senior Medical Adviser, Medical Manager, Associate Medical Director, Medical Science Liaison (MSLs), Medical Information Officers.

Qualifications: Medical Degree, MD, MBBS, MBChB, PhD, GPhC, MPharm, GMC Registration (UK).

Salary band: £110,000 - £180,000 Basic Salary, Bonus, Car Allowance, Long Term Incentives, Share Options, Pension, Private Medical Care, Dental Care

Medical Director jobs