CK Clinical are recruiting for a Head of Medical Development and Safety for an expanding global pharmaceutical company, based from their offices in 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.
Head of Medical Development and Safety Role:
As Head of Medical Development and 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.
- Strategic level decision making with respect to Pharmacovigilance and Clinical Development.
- 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.
As Head of Medical Development and 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 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.
For more information or to apply for this Head of Medical Development and Safety role, please contact Jim Gleeson on 01438 842973 or email firstname.lastname@example.org, quoting job ref 48221.
It is essential that applicants hold entitlement to work in the UK.