An exciting opportunity has arisen for a Pharmacovigilance Physician to become VP to oversee and provide oversight of all PV activities. You will be expected to ensure appropriate medical safety assessments, surveillance, regulatory reporting and communication of safety information. This role is based across Europe, with the chance to join a life changing company.
- Advance and maintain the safety governance oversight for all products
- Build and manage a high-growth pharmacovigilance team, including recruitment, training, assessment, monitoring and development. Communicate company/departmental information effectively to team.
- Provide global strategic leadership by setting clear expectations & providing hands-on leadership for PV, promoting collaboration and team cohesiveness.
- Oversee all PV-related activities performed by external suppliers/consultant, ensuring appropriate documentation and governance frameworks are in place
- Interact with internal and external staff to develop programs and processes to meet regulatory reporting requirements.
- Lead process improvement within global pharmacovigilance - including technology assessment and implementation.
- Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including review of clinical study protocols, development plans, INDs/CTAs and serious adverse event handling and all other PV issues, as appropriate.
- Oversee aggregate reporting, management of risk-benefit profiles, signal detection and risk management and mitigation plans for clinical and post-marketing compounds.
- Directly oversees the PV staff and operations globally to ensure high quality case processing and aggregate reporting consistent with quality performance metrics.
- Successfully plan and forecast for global resources and PV budget and partner with other groups on resource needs (e.g., medical organisation for writing and statistical staffing; medical affairs for epidemiology project needs).
- Implement global process standardisation and improvement.
- Provide safety expertise to other departments and functions.
- Ensure PV staff are able to meet safety monitoring needs based on regulatory requirements and company standards for pharmacovigilance and are audit-ready.
- Represent PV in audits with health authorities and development partners.
- Oversee development of training modules and provide training in Pharmacovigilance across the Company.
- Oversee aggregate medical review and signal detection/analysis activities for the product portfolio
- Ensure compliance of operations with governing regulatory requirements
- It is imperative that employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
Skills and Requirements
- MD, degree or equivalent
- At least 8 years of pharmaceutical industry experience, including at least 5 years in pharmacovigilance management roles
- Team player who is able to prioritise workload in a fast-paced environment
- An individual willing to embrace our culture, and work to instill the values of the Department within their working relationships
- Ophthalmology knowledge and experience
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