Head of Pharmacovigilance and Medical Safety

CK Clinical is recruiting for a Head of Pharmacovigilance and Medical Safety for a successful speciality pharmaceutical company, based from their offices in central London, though home-based during the current crisis. You will hold a leadership role, taking responsibility for all PV activities for clinical trials and clinical development products. Responsibilities: As Head of Pharmacovigilance and Medical Safety you will be responsible for the effective delivery of and continued evolution of pharmacovigilance (PV) activities for clinical trials and clinical development products) in order to meet regulatory requirements, company objectives and quality standards.

Provision of medical oversight and input for clinical trials. Ensuring that PV staff are motivated to contribute to and achieve departmental and divisional targets. For EU studies, assume responsibility as the Responsible Person for EudraVigilance for clinical trials. Manage the safety profiles of clinical development products, including signal detection. Interpret safety data to educate and support OPUK project teams in preparation for external meetings with Key Opinion Leaders, Investigator Meetings, Competent Authority(s), Ethics Committees etc.

Qualifications: As Head of Pharmacovigilance and Medical Safety you will require:

A medical degree, a higher degree (Masters, PhD, MBA) is preferred. Significant demonstrable experience of PV in a global environment, particularly in the EU and US, with a good awareness of regional variations in culture and local PV requirements. Proven line managerial experience. Proven experience in all clinical aspects of a trial with a strong knowledge of SOPs and accepted practices. Strong interpersonal and communication skills when dealing with internal and external clients/vendors, supporting colleagues and making presentations.