Key People
,
London, Greater London
PV Officer / Senior PV Officer
Overview
Job Description
An excellent opportunity has arisen for a PV Officer / Senior PV Officer to join an established Pharmaceutical company based in South West London. Within this role you will ensure that pharmacovigilance (PV) activities are performed in accordance with current legislation. Responsibilities: - Is recognised as the primary contact for all Adverse Events (AEs) - Ensures appropriate reporting and management of all AEs received from healthcare professionals and patients/consumers - Performs regular AE searches in relevant scientific literature - Conducts reconciliation of case data with partner companies in a timely manner and in accordance with agreements. - Ensures PSURs are submitted in accordance with agreed schedules - Ensures consistency of PV activities globally within the company - Maintains oversight of 3rd party PV providers - Ensures risk management plans are in place and any risk minimisation measures are implemented - Prepares/review SOP's where required. - Provides Pharmacovigilance training and materials for new employees and refresher training for existing employees - Maintains effective dialogue with pharmacovigilance contract providers - Monitors performance and works with provider to overcome any issues - Ensures regulatory changes to product information are provided in timely manner to the pharmacovigilance contract provider Qualifications and Experience: - Educated to degree level in a science degree or equivalent - Attention to detail with the ability to multitask - Good IT skills - Ability to critically appraise scientific/clinical data - Excellent analytical and problem solving skills; effectively applies technical knowledge to solve non-routine problems - Excellent time management skills with the ability to plan and prioritise workload - Excellent verbal communication skills/positive telephone manner For further details about this role, please contact Tim Barratt on 01727 817 626 or email tbarratt@keypeople.co.uk