Head of Pharmacovigilance

Hobson Prior is working with a clinical-stage drug discovery and development discovering organisation who advance pioneering therapies to advance the standard of treatments for serious infectious diseases. Our client is looking for a Head of Pharmacovigilance to join them on a permanent basis in Boston.

Job Responsibilities:

• Responsible to lead global medical pharmacovigilance activities, operations, and risk management strategies in alignment with US, EU and ICH regulations.
• You will have oversight of vendors and their processes and output.
• Establish PV operation capability in (outsourced) case processing - specifically of US post-marketing case processing, (outsourced) production of quality documents like DSURs and RMPs, risk assessments.
• You will build, lead, and support the operations of a global function supporting development, through NDA/MAA filings, to approval and post-marketing.
• Facilitate cross-functional Safety Surveillance Team meetings; includes coordinating materials, data presentation and all outputs, and agenda.
• Accountable for medical-safety sections of aggregate safety reports (DSUR, PSUR).
• You will provide subject matter expertise and input for regulatory submissions, e.g., NDA, regulatory responses.
• Provide support - in collaboration with Medical Science - for safety sections of clinical documents including the review and approval of the safety portion of protocols, annual reports, final study reports and other as needed.
• Implement, execute, and maintain safety processes and systems that conform to the company's business strategy, industry standards and comply with global regulations.
• Further build the quality management system for PV including policies and SOPs.

Key Skills:

• Excellent written and verbal communication skills.
• Good team player.

Requirements:

• MD, PhD, or MSc with science background.
• A minimum of 10+ years of hands-on pharmacovigilance experience for a pharma/biotech company.
• Strong background in PV operations, case processing, and US post-marketing PV activities.
• Deep understanding of regulations, knowledge and practices required for pharmacovigilance, e.g. ICH guidelines, international pharmacovigilance regulation, industry practice with a focus on the US (knowledge and experience with EU regulations is strongly preferred).
• Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.

Apply now:

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.