Our rapidly growing client based in Hertfordshire are looking for a PV Project Manager to join their team ASAP.
The ideal candidate must have extensive Pharmacovigilance/Drug Safety project management and also experience of being client focused with the ability to multi task and to prioritise.
*Mentoring of specified members of the pharmacovigilance department
*To ensure that project specific mail boxes, fax machine and postage are checked daily for cases.
*To receive cases by telephone.
*To perform duplicate checks on case information received.
*To evaluate ICSRs for seriousness, expectedness and assess investigator or company supplied causality.
*To send notification and acknowledgement emails.
*To process ICSRs including MedDRA coding, narrative writing and tracking.
*To perform quality control on ICSRs.
*To evaluate ICSRs for additional information needed in order to fully evaluate the case according to the principles of good pharmacovigilance practice. To made arrangements for this additional information to be collected by contact with reporter or via CRO/CRA.
*To identify ICSRs requiring expedited reporting according to applicable requirements includes both paper based and electronic reporting.
*To prepare aggregate safety reports; PSURs, EU Ethics SUSAR reports, Annual SAE reports, Client specified reports (or appropriate sections of these reports) and other aggregate safety reports.
*To perform quality control on aggregate safety reports; *Liaison with other Pharmacovigilance departmental members, consultants, other client contracted service companies/contractors, client personnel or other groups in order to complete project activities.
*Preparation and maintenance of project specific SOPs, addendums, working instructions and other procedural document as required for the project.
*To set up, administer and maintain hard copy and electronic copy filing systems on a per project basis.
*To set up, administer and maintain tracking systems to record activities undertaken for a project.
*Production of monthly reports detailing project activities for submission to client
*To act in the best interests of the client to ensure that applicable pharmacovigilance regulations are adhered to and pharmacovigilance issues are identified and acted upon.
*To raise and initiate discussion on safety issues arising during the course of activities.
*Involvement in the set-up, validation and maintenance of project specific drug safety database schemas (ARISg).
*Participation in internal and external audits and inspections by health authorities.
*Performance of weekly literature searches to search for case reports and safety data of interest.
*Evaluation of weekly literature searches to identify case reports and safety data of interest.
*Production of reports to be used for signal detection
*Participation in signal detection meetings