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Pharmacovigilance Manager

Pharmacovigilance Manager

Job Title: Pharmacovigilance Manager
Contract Type: Permanent
Location: Harlow, Essex
Industry:
Salary: Negotiable
Reference: HQ00059659_1500916323
Contact Name: Richard Williamson
Contact Email: r.williamson@sciproglobal.com
Job Published: July 24, 2017 18:12

Job Description

The PV Manager will manage the Team Leaders and indirectly the PV team to ensure that all operational activities are completed in a compliant manner and will ensure that any key project deliverables are met.

The PV Manager will supervise, mentor and train members of the team and assess staff performance by performing reviews/appraisals as part of the performance management cycle. They will also ensure timely and effective communication including escalation of any concerns to other members of the Senior Management team.

The PV Manager will be expected to lead by example, be professional, diligent and act as a point of contact between the PV team and Senior Management/ stakeholders.

Main Responsibilities:

  1. Develop the processes and systems necessary to ensure that the business will meet both the current and future legislation requirements associated with providing a compliant Pharmacovigilance and Medical Information service.
  2. Assist in creating an organisation that can support the above, but still be cost effective.
  3. Ensure consistent quality and standards are upheld within the PV department.
  4. Be involved in the maintenance and generation of new business.
  5. Lead and contribute to client specific projects.
  6. Manage, train and mentor PV staff within the PV Company.
  7. Ensure smooth and efficient running of the PV department.

Client related activities:

  1. Act as a Qualified Person for Pharmacovigilance (QPPV) or Deputy Qualified Person for Pharmacovigilance (dQPPV).
  2. Act as the Responsible Person (RP) for clinical trials.
  3. Act as a Client Manager and back-up client account manager for clients and colleagues respectively.
  4. Communicate with internal and external customers.
  1. Ensure that any systems and processes introduced maintain the confidentiality of client's internal processes.
  2. Provide training/education as necessary to clients on aspects associated with MI/PV.
  3. Participate in the team ethos to ensure a high standard of Client care.

Miscellaneous:

  1. Maintain an awareness of current legislation associated with the Regulatory Pharmacovigilance requirements and ensure that other members of the company are informed and trained as necessary.

Other Pharmacovigilance activities:

  1. Knowledge and use of the Pharmacovigilance database for processing of Adverse Events and Adverse Drug Reactions
  2. Review of literature searches and assessment of data for safety signals and ICSRs.
  3. Compilation and presentation of quality metrics.
  4. Maintain a computerised database for the capturing of ICSRs.
  5. Act as the Literature Process Owner.
  6. Advise customers of any actions they may need to make following the identification of a change in the drug's safety profile.
  7. Ensure that all cumulative safety reports, e.g. Periodic Safety Update Reports (PSURs) and Drug Safety Update Reports (DSURs) are completed and filed with the appropriate Regulatory Authority within the legislative timelines.
  8. Develop Risk Management Plans (RMPs) as required, in line with relevant guidelines.
  9. Ensure that the buiness maintains a current file (SmPC, core safety data sheet) on client products.
  10. Involvement in the maintenance of PV System Master File (PSMF).
  11. Review of SmPCs against market leaders for generic clients.
  12. Lead and partake in signal management meetings.
  13. Any other duties as required from time to time - these may include authoring/review of Addendum to Clinical Overview, Clinical Expert Statements and other required safety reports.

For more information please apply to this advert or call Richard on 02033273072.

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