Manager Pharmacovigilance & Epidemiology (PVE
12 Month contract based in Cambridge
The Pharmacovigilance and Epidemiology (PVE) department is a global function that is part of Research and Development w. The main Pharmacovigilance activities of PVE are centered at three sites: 2 in the USA and one in Cambridge in the UK.
PVE Operations - This group is responsible for case processing from receipt through to submission to external parties and is also responsible for the operational support of clinical studies.
Medical Safety Science - This group covers the medical input and scientific evaluation of safety data including ICSRs, aggregate data, risk management plans, aggregate reports and signal detection.
Epidemiology - This group provides epidemiological support throughout all stages of a product lifecycle.
Standards and Collaborations (S&C) is the group where the vacancy exists, and the role is based in Cambridge UK. This group is responsible for safety language in contracts, vendor oversight of safety information reporting for global Patient Assistance and Support Programs, market research and social listening projects, authoring Pharmacovigilance agreements (PVA) with license partners and CROs, audit and inspection readiness/support, pharmacovigilance training, Management of the Pharmacovigilance System Master File, PV compliance and quality measures and managing the Pharmacovigilance Responsible Persons with global affiliates and supporting PV in Distributor countries across the world.
Sciences is seeking an ambitious individual to join the Standards and Collaborations team as a Manager, responsible for creating, update and maintenance of Clinical Trial Reporting Procedures (CTSRPs) between us and contracted CROs for Clinical Trials globally.
This is a role responsible for ensuring timely and appropriate safety exchange between us and contracted CROs for our Sponsored Clinical Trials to meet Regulatory Reporting timelines in applicable countries. The individual will be responsible for following internal processes to ensure CTSRPs are sufficient to meet compliance with CT and GVP standards.
At a minimum, the ideal candidate will possess:
Scientific background with a medico-scientific university degree
- Previous experience in multiple aspects of pharmacovigilance activities
- Project management experience preferred or experience in managing complex projects
Working knowledge of global safety regulatory requirements
- Proven good communication skills and evidence of ability to work in cross functional teams
Essential Duties and Job Functions:
- Demonstrates excellent scientific/clinical or analytical knowledge base, with ability to assess data and understand the safety/medical or process implications
- Demonstrates excellent verbal and written communication skills
- Demonstrates excellent attention to detail, teamwork and initiative
- Able to plan effectively to create, update and maintain CTSRPs in a timely manner
- Author and coordinate cross functional contributions to Clinical Trial Safety Reporting Procedures (CTSRPs).
- Works with internal and external parties to clarify any inconsistencies or issues with responsibilities and terms and conditions described in the CTSRP
- Highlights areas of concern to manager; able to make recommendations for and implement processes for improvement
- Competent in abilities in area of expertise and the wider areas of PVE
- Has an appropriate level of IT skills in Microsoft Excel, PowerPoint and Word
- Able to work as a member of a cross-functional team.
- Able to gather information or assign tasks or activities for a given project with minimal direction. Acts as project lead
- Establishes work priorities with minimal direction from manager. Work is performed without appreciable supervisory direction
- Provides regular updates to manager, including challenges and suggested actions that could be taken
- Able to maintain confidentiality (especially on patient records), with good attention to detail and a high level of concern for accuracy and quality
- Actively participates in S&C meetings and shares information on projects and challenges openly
- Recognizes potential or impending problems, implements and delivers solutions
- Maintains compliance with PVE and applicable SOPs and work instructions
- Maintains knowledge of company disease and therapeutic areas
- Has a good knowledge and understanding of applicable regulatory requirements.
- Exercises some latitude in determining objectives and approaches to assignment
- Develops solutions to complex problems which require the regular use of ingenuity and innovation, ensuring solutions are consistent with organization objectives; contributes to the development of new concepts, techniques, and standards
- Serves as consultant to PVE management in area of expertise and acts as a spokesperson for the PVE organization in matters pertaining to its policies, plans, and objectives in their area of expertise
Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.