Pharmacovigilance Manager, Northern Cluster

at Kyowa Kirin International plc

Marlow, UK hybrid

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose:

Responsible for the Pharmacovigilance system and activities covering the Northern Cluster territories: United Kingdom (UK), Ireland, Nordics (Denmark, Finland, Iceland, Norway, Sweden) and Baltics (Estonia, Latvia, Lithuania).

Act as the registered National Contact Point for Pharmacovigilance with the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Key Responsibilities:

• Serve as the registered National Contact Point for Pharmacovigilance with the UK Medicines and Healthcare products Regulatory Agency (MHRA)
• Act as Local Safety Officer (LSO) for Northern Cluster Territories: UK, Ireland, Nordics and Baltics
• Maintain current knowledge of local regulatory PV requirements
• Ensure local vendors adhere to contractual obligations and maintain compliance with GVP and local PV regulations
• Serve as primary point of contact for the receipt of Individual Case Safety Reports (ICSRs) from the Territory
• Ensures local processing, documentation, translation (to English), follow-up and archiving of ICSRs, and timely transmission of ICSRs to Global Case Management
• Manages communication with local Health Authorities (HA(s)), this includes, but is not limited to, ad hoc queries, Urgent Safety Restrictions, Urgent Safety Measures, and the dissemination of Direct Healthcare Professional Communications (DHPCs) in accordance with global and/or local procedures
• Prepare and maintain the local procedural documents to ensure compliance with local regulatory PV requirements and in line with global processes and procedures
• Participate in PV trainings to stay updated on regulatory requirements
• Conduct PV training for local affiliate non-PV personnel (e.g. new personnel) and/or other parties as per relevant procedural document

Position Requirements:

• University degree in Pharmaceutical Sciences or equivalent
• Relevant experience of PV within the pharmaceutical industry
• Knowledge of relevant laws and regulations in the territories (i.e. local and EU regulations, ICH Guidelines, and GxP requirements)
• Knowledge of relevant therapeutic areas is an advantage
• Experience in translating corporate strategies into a local context, and a level of commercial awareness
• Fluent in English, both verbal and written
• Strong analytical, organisational, and communication skills

Kyowa Kirin International is an equal opportunities employer.

No agencies please.