I am currently recruiting for an interim PV Physician to join a client on an initial 3 month contract basis. Within this role you will execute and manage Pharmacovigilance projects global clients. This role is 100% home based!
*Author Risk Management Plans (RMP) and review of RMP updates
*Medical Review of PSURs/PBRERs per the Regulations and SOPs.
*Authoring Benefit Risk sections of aggregate reports
*Review of Literature reports for ICSR identification and signal detection
*Medical Review of ICSRs for purpose of expedited/ periodic reporting for client's products including MedDRA coding, labelling assessment and causality assessment.
*Preparation of responses for queries to be submitted to regulatory authorities.
*Contributing as part of the Medical review team to develop processes, training plans/modules and SOPs.
*An EU medical degree.
*Strong post-marketing pharmacovigilance experience to include risk management, signal detection, aggregate report writing and medical review experience, either in a pharmaceutical company or with a CRO is required.
*Experience in writing risk management plans, benefit risk assessments and signal detection is essential.
*Experience of Medical Review of Literature reports for ICSR and signal detection purposes is highly desirable.
*Experience of medical review of ICSRs for purposes of expedited/ periodic reporting for client's products including MedDRA coding, labelling assessment and causality assessment is desirable.
*Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines.
*Team management and project management experience.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to firstname.lastname@example.org