Head of Pharmacovigilance
Here at Quanticate we are looking for an experienced Head of Pharmacovigilance to join our team. As Head of Pharmacovigilance, you will be part of our group management team where you will oversee the process and efficacy of the team.
Along with a competitive rate and company benefits, we offer remote working from anywhere in the UK. We also offer the option to work on a hybrid or fully on-site basis from either our Manchester or Hitchin (Hertfordshire) locations. for those who are keen to return to office life.
- To provide oversight and leadership to the Pharmacovigilance (PV) function within Quanticate, to deliver compliant, high quality and efficient PV services, achieving a high degree of customer satisfaction, whilst maximising revenue and profit.
- Ensure the recruitment, development and retention of high calibre PV staff, in addition to integration of contractor staff, to establish a first-class PV functional team.
- Provide ongoing team management including resource planning and allocation of PV projects; drawing on the PV functional team to form highly effective PV project teams to ensure projects are delivered to time, quality and budget.
- Provide high level oversight, guidance and advice for PV projects, in addition to conducting of ongoing PV activities such as acting as Responsible Person / Trust Deputy for EudraVigilance, review of safety data and safety concerns, and taking on activities of, and acting as back-up for, other PV operations team members, as required.
- Provide ongoing management of a fully compliant, industry-standard safety database to fulfil Quanticate and customer requirements. Also, ongoing utilisation of management reports generated from the safety database to monitor compliance, quality, efficiency and training needs.
- Accountable for establishing and maintaining a realistic budget for all direct costs for the PV team. Accountable for maintaining a headcount level within the PV team that is line with sales forecasts.
- Accountable for the profit and loss delivery of the PV business.
- Pharmacy, life science or healthcare degree.
- Desirable: Advanced degree
- 10 years + extensive hands on experience in all aspects of PV, both clinical trial and post-marketing, gained in the pharmaceutical, CRO or regulatory sector.
- Experience of managing a PV functional team.
- Experience of Quality Management aspects of PV, including SOP and Working Practice development and participation on audits and inspections.