ProClinical is partnering with a biopharmaceutical company focused on developing cancer treatments to announce a vacancy for a Senior Director, Pharmacovigilance. The organisation prides itself on its product development programs, which target specific subsets of cancer, and is seeking for an experienced and dynamic applicant to join their team based in the UK. This is an exciting opportunity to work with an illustrious company whose expertise ensures customer satisfaction.
The Senior Medical Director, Pharmacovigilance (PV) will serve as an experienced pharmaceutical physician with strong clinical and pharmacoepidemiologic experience in pre and post marketing settings. They will utilise their ability to analyse safety data, identify, detect, and investigate safety signals, evaluate and proactively manage risks, and provide medical safety review for the company's investigational compounds and marketed products. They will also provide medical input into activities associated with serious adverse events from clinical trials and post-marketing adverse events and will co-author aggregate safety documents, including NDA/MAA submission safety documents, periodic reports and responses to regulatory questions. The Senior Medical Director will represent the company at internal and external meetings and must be versed in policies and procedures regarding PV and product quality that align primarily with prevailing EU and other locally applicable regulations, including PRAC.
Job Responsibilities:
- Serving as the PV medical lead and primary point of contact for one or more programs at the company, providing PV support for compounds in clinical development and/or marketed products as appropriate.
- Accurately identifying, developing, analysing and summarising safety issues that require further evaluation utilizing data from the safety and clinical databases as necessary.
- Authoring or contributing to safety sections of clinical investigator brochures, protocols, CSRs, core safety information, labels and regulatory reports (e.g. PSUR, DSUR, 6-monthly SUSAR line-listings) with focus on providing overview for the medical analysis and safety sections.
- Authoring or contributing to Safety sections of NDA/MAAs and other regulatory submissions (e.g., integrated summary of safety, and/or summary of clinical safety, PSMF, RMP, etc.).
- Leading signal detection and risk management activities for designated product(s).
- Implementing proactive safety analysis strategies to further define the safety profile.
- Leading aggregate safety data review activities and coordinate safety surveillance activities.
Skills and Requirements:
- An M.D. degree or EU equivalent.
- A minimum of 10 years' experience in PV organizations in the pharmaceutical/biotechnology industry is required. Oncology experience will be a significant advantage.
- Experience in clinical and post-marketing safety and pharmacoepidemiology.
- Knowledge of current pre and post-marketing EU and international safety regulations.
- Advanced ability to analyse and interpret clinical data.
- Experience of unsupervised medical review of serious adverse event cases.
- Experience and training in MedDRA coding, and coding review.
- Thorough knowledge and experience in all aspects of safety reporting for clinical trials and marketed products.
- An in-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements pertaining to drug safety and risk management including ICH, 21 CFR, FDAAA, and EU GVP module and able to influence decisions at all levels relating to patient safety.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at +44 07 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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