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About the job
An excellent opportunity has become available for an experienced PV Writer to join my client based in Hertfordshire 2 days home working is possible.
Within this role you will be responsible for authoring Pharmacovigilance aggregate reports, including PBRERs, DSURs and RMPs. Evaluation of aggregate safety data and experience of signal management would be ideal. Project management experience would be a benefit.
Evaluation of aggregate safety data, authoring of PV reports and signal management activities.
Process implementation and ensuring process compliance.
Create errorfree reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management. Undertake the QC activity for tasks performed by other team members on an ongoing basis.
Identify and provide standards for gathering information for use in trend analysis and reports information to company management. Interact with the client on a regular basis to understand the clients requirement for a particular project and ensure expectations are exceeding the targets in terms of quality, quantity within the scope of time constraints.
Creating or updating the SOPs, WINs as per project specific requirements. Responsible for training and mentoring of team members depending upon the project requirement.
Skills & Experience:
Bachelors degree in scientific domain.
Significant Pharmacovigilance industry experience within a pharmaceutical company or at a CRO.
Experience of authoring of Pharmacovigilance aggregate reports, including PBRERs, DSURs and RMPs, evaluation of aggregate safety data and experience of signal management. Good understanding of clinical development processes including principles of clinical study operations, and ICHGCP guidelines.
Experience of managing writing teams in Pharmacovigilance domain is desirable. Project management experience is desirable.
For further details about this role, or other opportunities within Drug Safety or Pharmacovigiliance, please contact Tim Barratt on or email #####@######.###