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

Clinical Research - Pharmacovigilance Manager Jobs - Berkshire (Job Ref: WR/JOBS/23118-9504)

Job Description :

Flame Pharma Clinical Research – Pharmacovigilance Manager Job - Berkshire:

Job Summary

This excellent Pharmacovigilance Manager opportunity will report directly to the Head of Pharmacovigilance for our client, an innovative and progressive CRO.  If you have proven pharmacovigilance/drug safety experience, coupled with line management experience in a CRO or Pharmaceutical company, then we would encourage you to contact us.

Job Title

Pharmacovigilance Manager

Background

Utilising your awareness of global regulatory and pharmacovigilance environments, the Pharmacovigilance Manager will be responsible for the pharmacovigilance activities for assigned studies whilst acting as line manager for Pharmacovigilance Executives and Administrators.  You will also be instrumental in business development and client liaison.

Key Responsibilities

• Generates and updates Serious Adverse Event Management Plans.
• Generates instructions for the completion of Serious Adverse Event forms.
• Configures and validates safety systems for specified projects.
• Manages and processes expeditable Serious Adverse Event Reports.
• Reviews and updates Serious Adverse Event databases and tracking systems as  required.
• Reviews Serious Adverse Events for completeness, accuracy and appropriateness for expedited reporting as required.
• Reviews patient narratives.
• Reviews the coding of Serious Adverse Events.
• Generates queries for sites to obtain required follow-up information as required.
• Reviews reporting of expeditable Serious Adverse Events to clients, regulatory authorities, ethics committees, investigators and project team personnel, if required, within study specified timelines.
• Reviews letters for submissions on expedited safety reports.
• Provides independent QC of AE reports for members of the pharmacovigilance group.
• Works with the Biometrics department on reconciliation of safety databases.
• Assists in the validation and implementation of upgrades to the PV Works™ safety database, in conjunction with COMPANY IT department and the vendor.
• Assists in the generation and review of proposals and costings for pharmacovigilance business.
• Presents safety capabilities at business development presentations to clients.
• Reviews Clinical Trial Protocols, Case Report Forms and Serious Adverse Event Reporting forms.
• Attends and presents on Serious Adverse Event reporting at Investigator Meetings.
• Participates in COMPANY project teams and provides training on Serious Adverse Event reporting.
• Attends client meetings and liaises with clients where appropriate.
• Reviews cumulative safety data for submission to DSMBs, regulatory authorities or clients as required.
• Manages the set-up of, and provision of data to, Safety Committees/Drug Safety Monitoring Boards.
• Assists with preparation and attendance at client or regulatory authority audits.
• Reviews pharmacovigilance budgets for allocated projects, identifies out-of-scope activities and works with Project Management and Business Development to process change orders.
• Assists with the recruitment of new staff to Pharmacovigilance Department.
• Trains and mentors new employees concerning Serious Adverse Event reporting.
• Assists with the management of the pharmacovigilance group concerning project allocation and resourcing.
• Assists with the generation and review of SOPs and WPGs.
• Builds and maintains good relationships across functional units and COMPANY affiliates.
• Other duties as assigned by management.

Qualifications and Experience

• Extensive experience in the CRO or pharmaceutical industry including proven pharmacovigilance experience.
• Proven line management experience.
• Awareness of global regulatory environment.
• Good awareness of global pharmacovigilance environment.
• Experience of a variety of safety databases.

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 30000-40000 plus bi-annual bonus scheme.

Key Words

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

The position will be based in Berkshire.

For further information about this role, please contact Flame Pharma.