PV Medical Director

PV Medical Director
Temporary role
Remote
circa. -(Apply online only) per day

SRG are supporting one of the leading global pharmaceutical companies with their search for a new Medical Director to support the PV/Drug Safety team on a temporary basis. This 6 month contract will be great for a Senior PV or Drug Safety Physician with ample experience in a similar role. You will need to have worked regularly within Safety Evaluation and Risk Management tasks and be able to start at short notice. While not essential, experience within Oncology in particular - will be a great advantage.

Key responsibilities include:

• Conducting routine pharmacovigilance tasaks including signal detection activities and signal validation/assessment
• Authoring & reviewing key regulatory documents (e.g. DSURs, EU RMPs and PBRERs) as well as responses to regulatory questions
• Supporting identification of needs for product labelling updates
• Driving proactive implementation of risk management initiatives
• Facilitating safety governance/SRTs in the clinical development (and post marketing) settings by assisting in the establishment and operation of cross-functional teams in any SERM to detect and address product safety issues
• Ensuring that adverse event(s) and other safety information is efficiently evaluated and accurate to meet global compliance and regulatory requirements

Skills/Experience needed:

• Medical degree (e.g. MD, MBBS) - GMC registration strongly preferred
• Some clinical experience post-registration
• Experience within the pharmaceutical industry, within Drug safety / PV
• Therapeutic area experience within Oncology desired
• case review of adverse events from clinical trials - not case management but Medical review experience required from a safety perspective in clinical trials
• Specific experience within Safety Evaluation and Risk Management activities
• Argus drug safety experience or similar drug safety database experience
• Ability to contribute successfully to teams
• Strong verbal and written communication skills

If interested, please follow the link to apply or get in touch with Theo Charles to discuss further!

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.