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Title:

Pharmacovigilance Scientist

Company:

Ipsen Ltd

Job Description:

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.

We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.

We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.

As Pharmacovigilance Scientist you will support, contribute and assist, the Local Pharmacovigilance Manager (LPM) in the provision of a comprehensive, accurate and timely local Pharmacovigilance (PV) activities for the UK and Ireland, within the framework of all applicable internal policies and procedures through Good Pharmacovigilance Practices (GVP) including conformance to Part 11 (Regulation 182) of the Human Medicines Regulation (2012) as amended.

In this role you will be accountable for:

Maintaining Compliance

• Ensure compliance with the Human Medicines Regulations (HMR) and contribute to the establishment and maintenance of the UKI PV system. In addition, providing expertise on PV and medical topics through:
• Process of Individual Case Safety Reports (ICSRs) and ensure timely completion of all case processing activities in line with local regulations and company requirements.
• Determine and perform appropriate case follow-up, generating follow-up letters.
• Work in collaboration with Global Patient Safety (GPS) on case management activities.
• Provide information and conduct Pharmacovigilance training to Ipsen staff and third-party providers. Reconciliation of all adverse event reports from Third Party service providers, distributors, and licence partners.
• Support Patient Data Collection System (PDCS) registration, management, and reviews
• Manage the local literature review process, conducting reviews (on-line and hardcopy non-indexed journals) to identify potential ICSRs and to identify safety information in accordance with company SOPs.
• Maintain awareness of PV regulatory requirements and developments.
• Support timely delivery of safety dashboards for Leadership platforms.
• Contribute to vendor management as applicable.
• Management of departmental email inbox.

Ensuring High Standards

• Conduct PV activities in line with regulations and Company SOPs and comply with the ABPI Code of Practice
• Handle safety enquiries, in line with local and global procedures and systems
• Regular communication and sharing of best practice
• Assist in maintaining, improving, and promoting the Medical Information/Pharmacovigilance service through contributing to projects and training of or liaison with other groups or customers
• Responsible for maintaining an up-to-date training record
• Ensure inspection readiness across all tasks maintaining quality and industry standards.

If you feel that this could be the right next step for you and can point to a relevant experience in Pharmacovigilance and awareness in Pharmacovigilance Legislation. We would be delighted to engage with your application.

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IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.