Head of Pharmacovigilance & Medical Safety
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Hobson Prior are looking for a Head of Pharmacovigilance & Medical Safety to join a leading pharmaceutical organisation in London to be responsible for the effective delivery of and continued evolution of pharmacovigilance activities for clinical trials and clinical development products.
Responsible for staff, external consultants and Service Providers understanding their obligations for drug safety reporting in the US and EU within the required timeframes and to appropriate levels of quality.
Support all applicable PV regulations in the US and EU and, as appropriate, be mindful of the requirements for PV related to clinical trials in order to provide an effective representation of safety matters.
Manage the safety profiles of clinical development products, including signal detection.
Responsible for risk management activities for clinical development products.
For EU studies, assume accountability as the Responsible Person.
Assist with further development of PV within the company by keeping up to date with developments and regulatory changes.
Up hold line management responsibilities.
Assess the training needs of the PV Department and ensure relevant training and development is undertaken.
Manage and review the resource requirements of the PV Department, ensuring appropriate resource is justified and maintained.
Good awareness of regional variations in culture and local PV requirements.
Prior line management experience.
Able to organise and oversee multiple on-going tasks and understand the differing priorities.
Ability to manage projects that include cross-functional teams representing diversified areas.
Excellent IT Skills (PCs, Windows and Microsoft Office)
Excellent oral and written communication, organisational skills and personal presentation. The ability to communicate effectively in English.
Experience working in a team environment under time and resource pressures, with the capability of also working autonomously.
Good understanding of the work performed by other Drug Development functions and how they interact.
Excellent project management and time management skills, a flexible approach and be able to adapt in a constantly changing environment.
Educated to a minimum of degree level in a medical discipline.
A higher degree (Masters, PhD, MBA) is beneficial.
Noteworthy prior experience of PV in a global environment, particularly in the EU and US is essential.
Proven experience in all clinical aspects of a trial with a strong knowledge of SOPs and accepted practices.
Understanding of the principles of ICH-GCP, GMP and regulatory requirements in both EU and US.
Detailed current knowledge of regulations and guidelines within the following areas: GCP, GMP and GCLP.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
$300000 - $350000 per annum
Hobson Prior is working with a clinical-stage drug discovery and development discovering organisation who advance pioneering therapies to advance the standard