Pharmacovigilance Case Workflow Manager

CPL

Dublin, Dublin West

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Case Workflow Manager. The PV Case Workflow Manager (CWM) serves as team leader for Pharmacovigilance Associates (PVA) and Pharmacovigilance Specialists (PVSp), overseeing and coordinating case assignments. The PV CWM will also be responsible for overseeing case processing metrics; ensuring reporting plans are implemented, adhered to and updated on a regular basis. The PV CWM provides basic managerial support to ensure that timelines for case submission to regulatory authorities and partners are met. Coordinates review of case information and provides feedback when necessary. The PV CWM will set Key Performance Indicators for each staff member and ensure that annual reviews take place according to company policies. The PV CWM will liaise with PV Quality Management and Compliance Manager (PV QMCM) to document deviations from SOPs relating to case processing and providing assistance with generation and implementation of CAPA’s. Work closely with the training coordinator/PV QMCM and management to develop and document procedures. Supports QPPV and PV QMCM with distributor compliance and intervention. The successful candidate will be process-oriented and possess the ability to think strategically and work collaboratively in a highly dynamic setting. Responsibilities. Team leader of PVAs/PVSp team to ensure day to day management of case processing and other pharmacovigilance tasks. Mentoring junior associates and new starters in pharmacovigilance overview, database use, case processing and expediting reports. Delegation of tasks from QPPV on ad hoc basis. Flexibility and time management skills are required. Tasks will also include replacement of any absent member at meetings. Review, advise and approve relevant local and global guidelines, policies, Internal Procedures and SOPs across Affiliate companies. Assist in organizing or running searches of safety or regulatory databases. Review cases to assess the need for follow up. Ensure Good Documentation Practice. Maintain awareness of Pharmacovigilance regulatory requirements and developments. Drive PV Team compliance targets. Create and maintain contacts across all Affiliate companies to enable them to gain maximum benefit for the business from scientific affairs. Knowledge required on Good Pharmacovigilance Practice Guidelines , ‘Volume 9A’, and Guidelines on Eudravigilance. Safety: Work with line management / PV QMCM to ensure that adequate SOPs exist for all safety related Pharmacovigilance activities to be carried out in line with Good PV practices and according to worldwide Pharmacovigilance and EU regulations/requirements, to include activities by independent contractors and other third-party vendors where necessary. Preparation and coordination of reviews of individual case safety reports as well as aggregate safety data. Perform literature Review. Manage safety related requests for systems or drug safety related information to ensure any requests are answered fully and promptly. Support Pharmacovigilance Physicians, on tasks such as case series review, data review and drafting of reports. Assess cases for seriousness and expectedness and identify SUSARs. Enter adverse event information on to the Safety database as per guidelines and SOP’s and run reports and queries as required. Ensure fulfilment of regulatory reporting requirement for adverse events within stipulated timelines. Prioritising and managing team and individual workloads to ensure regulatory and business partner timelines are adhered to for the reporting of SAE data. Review/input into post-authorisation safety study protocols and study reports at local and global level. To review AE listings to identify data issues and safety trends as required. To follow up any queries / issues raised as a result of reconciliation. Assist in the preparation/design of the safety reporting plans of individual products as per reporting requirements in different countries. Training: Oversee training and mentoring other Pharmacovigilance officers and specialists. Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance activities by liaising with the PV QMCM and EU QPPV. Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature. Requirements. Life Sciences Degree or equivalent. Documented experience in all aspects of Pharmacovigilance (2 years minimum. Experience writing aggregate safety reports e.g. ASRs, DSURs, PSURs is desirable. Experience working with MedDRA coding dictionary. Database entry and manipulation for Safety Database. Pharmacovigilance practice and procedure. Marketing Authorisation rules and regulations. Working knowledge and familiarity with clinical protocols, clinical study reports. Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies. Understanding of the principles of information storage and retrieval and skill in their application. Awareness of competitor products and activity. Literature search set up. If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. #THR2018. This job originally appeared on RecruitIreland.com.

1912 days ago