Drug Safety Public Health Specialist II

Job Description

My client are a leading pharmaceutical company with sites based across the UK.They are urgently recruiting for an experienced Drug Safety Public Health Specialist - IIThe role is based in Cambridge initially working remotely until the offices re open.The PVE department is a global function that is part of Research and Development.The main Pharmacovigilance activities of PVE are centred at two sites: USA, and Cambridge, UK.PVE is organized into four functional areas plus the EU QPPV. Heads of each function, the VP and the EU QPPV form the PVE leadership team.The four functional areas are:

Operations -

Medical Safety Science

Epidemiology

Standards and Collaborations is the group where this role will sit.

The PVE department is a global function that is part of Research and Development within Gilead. The main Pharmacovigilance activities of PVE are centred at two sites: Foster City, USA, and Cambridge, UK. PVE is organized into four functional areas plus the EU QPPV. Heads of each function, the VP and the EU QPPV form the PVE leadership team. The four functional areas are: Operations - responsible for case processing from receipt through to submission to external parties and are also responsible for the operational support of clinical studies. The Systems team also site within this group and are responsible for all aspects of data retrievals from the safety database. Medical Safety Science - covering medical input and scientific evaluation of safety data including ICSRs, aggregate data, risk management plans, aggregate reports and signal detection. . Epidemiology - provides epidemiological input into the design of risk management plans as well as risk evaluation and mitigation strategies. The group also provides input in the design of any observational studies that may be the result of a post-marketing requirement or commitments. Standards and Collaborations is the group where this role will sit. This group is responsible for the continuous review and coordination of PVE-related policies and standards, review of global regulations as well external collaborations. It is responsible for ensuring procedural documents are in line with regulations and internal policy and process, safety language in contracts and for safety input into solicited program activities, Clinical Trial Safety Reporting Procedures (CTSRPs), Pharmacovigilance agreements (PVA), audit and inspection readiness/support, training, performance and quality measures, reconciliation and affiliate/distributor support. Specific Responsibilities Specifically, this role is part of the existing Performance Team, the group who are responsible for PVEs various compliance reports, quality assurance activities and reconciliation. The team work on a number of quality assurance activities, produce a number of different compliance reports and are also responsible for Product Complaint, Medical Information, and Third-Party Reconciliations. This role would be responsible for the generation, review and validation of data related to these activities, working with various functions to determine requirements for corrections, to include tracking and collating responses. In addition, the role involves analysis and trending data and escalating any continuing or significant non-compliance and performance issues. Essential Functions: * Able to gather relevant information appropriate for a given task or activity * Able to plan effectively to receive, produce reports or data in a timely manner - establishes work priorities with minimal direction from manager * Participates in the production of reports or data for performance metrics, quality assurance or reconciliation activities * Works with internal or external third parties in the areas of performance metrics, quality assurance and/or reconciliation activities to clarify any data inconsistencies or trends * Assists in business continuity records management and PVE record retention reviews * Complies with new regulatory requirements in area of responsibility * Recognizes the need for and is able to seek assistance from appropriate internal and external resources in the area of responsibility * Highlights areas of concern to senior staff or manager able to make some recommendations for improvement * 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 * Good communications skills * Competent in abilities in area of expertise * Maintains compliance with PVE and applicable SOPs and work instructions * Maintains knowledge of company disease and therapeutic areas * Has an awareness and some understanding of applicable regulatory requirements * Has an appropriate level of IT skills in Microsoft Excel, PowerPoint and Word * Able to work as a member of a team * Actively participates in S&C meetings and shares information on projects and challenges openly Knowledge, Experience and Skills: Note: The following represent common education and experience but not mandatory requirements. * An individual with a medico-scientific university degree * Previous experience in drug safety or clinical research required * Proven good communication skills and evidence of ability to work in cross functional teamsParkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer. Required skills

Drug Safety

Keyskills :
Drug Safety