Find a Job
450 available
Back to all search results

Case Workflow Manager

Ref: 921317

  • €42,000 - €46,000
  • 21 Mar 2019
  • Dublin (South)
  • Perm

Brightwater are urgently seeking a Case Workflow Manager to serve 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

Duties

• 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.

General

• 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 • 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. • Ensure fulfilment of regulatory reporting requirement for adverse events within stipulated timelines. • Review/input into post-authorisation safety study protocols and study reports at local and global level • Assist in the preparation/design of the safety reporting plans of individual products as per reporting requirements in different countries

Experience

• 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

Benefits

• Competitive Salary • Pension • Bonus • Healthcare Contribution To apply for this Case Workflow Manager role, click the “Apply Now” button or for more information, please contact Marc Bentley on 01 662 1000 or email m.bentley@brightwater.ie