GPV Scientist - Weybridge, United Kingdom - Clinigen

Description

Job Profile:

This role will be responsible for working cross-functionally and providing technical and scientific pharmacovigilance support to safety evaluation and risk management (which is part of Medical Services) team for Clinigen's and Client's products.

Key Responsibilities:

• Develop and maintain a thorough knowledge of the company's or client's products and be involved in the safety evaluation and risk management activities in compliance with regulatory requirements and company procedures.
• Responsible for maintenance and update of the Global Aggregate schedule and Signalling schedule, aRMM tracker etc.
• ·Author and QC safety reports (e.g., signal detection, aggregate reports) in a timely manner to meet global regulatory requirements.
• Ensure communication and appropriate management and escalation of any safety issues to SERM Lead.
• Responsible for communicating SERM activities by working cross-functionally internally or with clients.
• Attend signalling meeting as and when required and support with pre and post signalling meeting activities.
• Present in the signalling meetings to present findings from the signal management reports.
• Responsible for providing input in the monthly compliance report and presenting monthly KPIs to senior management, if required.
• Support risk minimisation measures activities (e.g., educational materials drafting and tracking), monitor implementation, compliance and effectiveness check of risk minimisation activities.
• Support with coordination, update and maintenance of the PSMF. Additionally support with integration of products into the PV system.
• Improve and enhance internal processes to increase efficiency and develop departmental tools to ensure compliant completion of delegated client services as required.
• Actively participate and support with audits and inspections.
• Train and mentor junior employees to support safety evaluation and risk management activities.

Requirements

• Bachelor's Degree in Biological/Life Sciences, pharmacy or medicine.
• Post-graduate qualification preferred.
• Previous proven Pharmacovigilance experience with strong knowledge of Pharmacovigilance legislation.
• Ability to build relationships with key stakeholders and external parties i.e., partners/distributors/service providers.
• Ability to work collaboratively within a matrix and/or cross-functional environment.
• Excellent attention to details and ability to work under pressure.
• Self-motivated and organised, with the ability to work unsupervised.
• Excellent analytical thinking, with the ability to evaluate and present complex safety data applying sound judgement.
• Excellent prioritisation and time management skills.
• Extensive knowledge of MS Office Applications and systems.
• Excellent written, verbal and interpersonal communication skills.
• Proven experience of handling multiple tasks in a fast-paced and constantly changing environment.
• Willing to provide bank holiday coverage on a rotational basis.