This individual will be responsible for providing medical expertise for review and analysis of the safety of the Company’s investigational and post-marketing assigned products, to ensure consumer, prescriber and regulatory authority confidence. You will provide core medical pharmacovigilance input where required into the product teams and additionally provide drug safety expertise and support for clinical trials. This is a hands-on role given the size of the business so there will be procedural elements to the role, potentially writing SOPs etc.
 

Role Purpose:

• Provide professional expertise and advice to internal staff as well as competent authorities, physicians, pharmacists and patients by close interaction and communication with regard to drug safety related issues
• Safety surveillance (signal detection; signal evaluation; benefit risk assessment; risk mitigation) for all assigned products
• Responsible for the content of aggregate reports (PSURs, DSURs etc.) for assigned products.
• Act as medically qualified safety expert for assigned active moieties in clinical development, managing the drug safety and pharmacovigilance aspects of the clinical programme. This may encompass but is not limited to the following activities:
• Clinical trial set-up meeting attendance
• Safety input into the development and review of clinical trial documentation, including but not limited to:
• Investigator Brochure (IB)
• Study protocol
• Study training (internal and external) on ICH/EU guideline compliant safety reporting during conduct of clinical trials
• Safety Management Plans (SMP)
• Study Master File (SMF)
• Interim and final data review
• Integrated Summary of Safety (ISS)

Requirements Include:

• University degree in medicine with GMC registration Broad experience in pharmacovigilance and drug safety for both investigational and post-authorisation products
• Previous experience in the conduct of due diligence
• Advanced IT skills, experience in working with MS office
• Advance knowledge of applicable legislation and guidance
• Broad medical / pharmacological knowledge in the medical areas / of the medicinal products relevant to Mundipharma beneficial
• Fluency in spoken and written English.