Job Description
Experienced Pharmacovigilance Officer (Hybrid role) This is NOT an entry level role.
3 month initial Fixed Term Contract
Immediate start preferred
The Pharmacovigilance Officer has responsibility for the conduct and delivery of Pharmacovigilance activities on assigned projects, management and oversight of incoming information, as well as input to the development and maintenance of TMC PV systems.
Integral to the PV department’s day-to-day operational tasks, the PV Officer will be responsible for a variety of pharmacovigilance activities. These will include safety database administration, PV case processing related work, such as the triage and data entry of incoming PV information (e.g. processing individual case safety reports – ICSRs), management of PV eTMF filing, communication with clients on key deliverables (project dependent). The PV officer will need to comply with the applicable regulatory requirements (e.g. GVP) as well as work to TMC’s SOPs, both in relation to clinical trials and with marketed products.
THIS IS A HYBRID ROLE: we expect the successful candidate be able to come to the office in Hartley Wintney, Hampshire, regularly.
Role-specific tasks include;
* Maintenance of SAE/SUSAR/AESI trackers
* Argus safety database administration
* ICSR case processing including triage, data entry, quality control and submission
* Issuing and tracking ICSR queries
* Working with PV physician to co-ordinate medical review of cases and drafting of analysis of similar events (AOSEs) as required
* Coding Adverse Events and the medicines/treatments recorded on the Adverse Drug Reaction and Serious Adverse Event reports, according to MedDRA & WHODrug standards
* Supporting SAE reconciliation with clinical databse(s) and eTMF filing, as required
* Liaising with the Sponsor / MA Holder on expediting Adverse Event reports as required.
* Organising and minuting TMC project team meetings
* Building and maintaining good relationships across all TMC functional units.
* Provide input and support to TMC to ensure compliance (including monitoring of departmental metrics) with current PV regulatory requirements
* Supporting PV audit and inspection activities, as required
* Other duties as assigned by management (e.g. supporting signal detection activities, PSMF updates etc.)