job details for:
Clinical Research - Pharmacovigilance Manager Jobs - Hampshire

Clinical Research - Pharmacovigilance Manager Jobs - Hampshire (Job Ref: WR/JOBS/14876-6256)

Job Description :

Flame Pharma Clinical Research - Pharmacovigilance Manager Job - Hampshire:

Job Summary

As a world leading CRO, few companies come close to offering drug safety and pharmacovigilance opportunities as our client.  Flame Pharma is looking to recruit an experienced drug safety/pharmacovigilance manager to compliment our client’s global drug safety and medical affairs operations, and provide the line management and direction of the drug safety division.

Job Title

Pharmacovigilance Manager

Background

Due to expansion, our client is looking to recruit a Pharmacovigilance Manager to oversee and manage drug safety associates/monitors and administrative staff within the division.  You will manage the regulatory reporting of serious adverse events according to applicable legislation and ensuring the drug safety monitoring of projects within the medical affairs department

Key Responsibilities

• To ensure regulatory compliance and adherence to applicable SOPs, SSPs/WPs for all projects.
• To manage and develop drug safety team, ensuring general training and mentorship for staff is carried out
• Assist the department head and medical monitors in monitoring project budgets and utilization of staff
• To develop and maintain resource forecasting tools for resource planning across projects.
• To coordinate and manage all department absence ensuring adequate cover
• Oversee preparation for internal or external audits and inspections.
• Oversee follow up activities on audit and inspection observations.
• Management of regulatory reporting of serious adverse events:
• To serve as knowledge resource on drug safety regulatory reporting issues
• To gather intelligence on reporting requirements in Europe (EU and EFTA states)
• To ensure that in projects, where COMPANY has the obligation to report SAE to competent authorities and/or independent ethics committees, legal requirements are met.
• Coordinate and supervise safety review of CRFs
• Participate in performance management of team as delegated by the department head
• Coordinate department interface issues, e.g. with data management, clinical operations etc
• Support implementation and use of new technology tools in the department

Qualifications and Experience

• Extensive relevant drug safety experience
• Proven supervisory experience and must be able to effectively motivate and lead a successful team
• Experience in safety database management preferable
• Medical/scientific/nursing or equivalent educational background
• Excellent oral and written communication skills
• Excellent knowledge of Microsoft Office and other relevant computer software programs.
• Excellent organisational and time management skills.
• Awareness of ISO standards

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary in the region of £45000 plus car allowance and bonus scheme

Key Words

Drug Safety, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

The position will be based in Hampshire