Associate Director of Pharmacovigilance

We are looking for a Pharmacovigilance Manager to join our Pharmacovigilance team on a 12 month fixed term contract. You will oversee the day-to-day operations of the PV department, working closely with the PV team and the Director of Pharmacovigilance to ensure smooth and effective departmental functioning. This role involves maintaining oversight of projects, ensuring compliance with all PV deliverables, and managing documentation, quality, workload, and resource allocation. The PV Manager is responsible for identifying and addressing gaps in Simbec-Orion’s Standard Operating Procedures (SOPs) and implementing necessary corrective actions. Additionally, they provide leadership and mentorship to the PV team, manage financial reporting and revenue tracking, and contribute to business development by reviewing proposals and supporting bid defence meetings. The PV Manager also serves as a key liaison with internal and external stakeholders, represents the department in audits and inspections, and ensures continuous process improvements while acting as the primary PV contact and backup for the Director of Pharmacovigilance when required.

Key Accountabilities

• Responsible for monitoring and managing departmental documents, quality, workload and resource allocation.
• Responsible for line managing employees within the PV Department, working on setting goals/performance, applying strong leadership skills and able to mentor the department.
• Ensure timely escalation of issues and concerns to the Director of Pharmacovigilance.
• Provide support to the Director of Pharmacovigilance and assist with the review of proposals, costs for PV business, and bid defence meetings.
• Work collaboratively with internal and external stakeholders to ensure the PV aspects of projects are managed in line with budget and scope of work and within agreed timelines to meet clients’ expectations.
• Perform departmental revenue comparison against PV team members' timesheets to ensure logged time is consistent with the total professional fees for the department and the revenue is in line with PV activities performed.
• Provide financial reports (when required) to SLT.
• Represent the PV department during internal meetings and external client or regulatory authority audits/inspections.
• Generate and review departmental SOPs and WI and perform a gap analysis.
• Identifies new training and development opportunities for the PV department.
• Works on continuous process improvement for the PV department.
• Performs daily operational PV duties, including case processing and submission, and acts as PV Safety Lead.
• Be the point of contact for PV and backup for the Director of Pharmacovigilance during leave.

Skills Required

ESSENTIAL

• BSc in Life Sciences or a related discipline, or equivalent qualification.
• Proven experience in a Clinical Research Organisation (CRO) or a similar regulated environment.
• Strong leadership and people management experience, with a demonstrated ability to mentor and develop teams.
• Hands-on experience with PV safety databases and data management systems.
• Comprehensive expertise in all aspects of pharmacovigilance, including case processing, aggregate reporting, regulatory submissions, and study leadership.
• In-depth knowledge of pharmacovigilance regulatory guidelines and industry best practices.
• Experience managing pharmacovigilance projects, ensuring compliance with timelines, budget, and scope.
• Proven experience in pharmacovigilance within clinical trials, ensuring adherence to regulatory and sponsor requirements.

DESIRABLE

• MSc or PhD in Life Sciences or an equivalent advanced qualification.
• MBA or equivalent qualification, demonstrating expertise in business strategy and management.
• Experience in business development activities, including proposal reviews, cost assessments, and client engagement.
• Therapeutic area expertise in Oncology and Rare Diseases, with a strong understanding of associated pharmacovigilance requirements.