Pharmacovigilance/Safety Physician

£100000 - £130000 per annum
02 Feb 2021
04 Mar 2021
Stephanie Maccioni
Full Time
Contract Type
Experience Level
Experienced (non-manager)
CK Clinical are looking for a Pharmacovigilance/Safety Physician to join a very exciting, forward thinking and growing biotech who work within Gene Therapy. This role will have a unique opportunity to join a company in an exciting phase that has the ability to transform the clinical management of ocular disorders.

Location: Remote based from their London office/Remote based from their US East Coast office

Salary: Competitive base salary plus bonus and company shares

Our client is looking for someone who is has passion for patients and who genuinely wants to change their lives for the better. The role of Pharmacovigilance/Safety Physician will be a vital contributor.

Role Responsibilities:
  • 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 (including external resources and outsourced PV functions) 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 organization for writing and statistical staffing; medical affairs for epidemiology project needs).
  • Ensure PV staff are able to meet safety monitoring needs based on regulatory requirements and company standards for pharmacovigilance and are audit-ready.
  • Oversee development of training modules and provide training in Pharmacovigilance across the Company.
Skills and Experience:
  • MD, degree or equivalent
  • A proven experience within pharmaceutical industry experience, including in pharmacovigilance management roles
  • Team player who is able to prioritise workload in a fast-paced environment
  • An individual willing to embrace the companies culture, and work to instil the values of the Department within their working relationships
Full job description available upon request.

Quote job ref 49718.

It is essential that applicants hold entitlement to work in the UK.