Our new Pharmaceutical client is looking for a Pharmacovigilance Officer to join their team on a permanent basis. You can either be based at their offices in Nottingham or Devon.
Purpose of job
-To assist the QPPV and deputy QPPV in meeting pharmacovigilance obligations.
-To monitor pharmacovigilance compliance metrics
-To undertake pharmacovigilance audits and to ensure partners comply with pharmacovigilance requirements in a timely fashion
-To provide medical information support
To undertake clinical regulatory activities
-To support the regulatory department
Main Duties and Responsibilities
Pharmacovigilance
*To support with the following pharmacovigilance activities
*Case processing including data entry, review and assessment of SAE/AE reports from clinical trial and post marketing sources in accordance with company SOPs and regulatory requirements.
*Assisting with SAE reconciliation.
*Undertaking of clinical regulatory activities.
*Provision of medical information support.
*MedDRA coding.
*Literature reviews.
*Contributing to the ongoing enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.
*Undertaking pharmacovigilance audits
Regulatory
-Undertake clinical regulatory activities
-Supporting the regulatory department