Safety Lead (Pharmacovigilance)
Brentford (Remote Working Available)
· Act as a deputy to the Named Safety Contact for the designated area(s) of the UK and Irish Pharmacovigilance systems.
· Deputise for the Head of Safety & Medical Information as required.
· Provide expertise on all legal and regulatory UK and Ireland pharmacovigilance requirements for internal colleagues and external customers.
· Responsible for leading and influencing internal stakeholders to embed robust safety management processes throughout GSK UK and Ireland Pharma and GSK Consumer Healthcare organisations for all activities in accordance with VQD-POL-000050 and ChimAERa activities.
· Responsible for the implementation and monitoring of effective operating policies and procedures relating to the UK and Irish businesses, including but not limited to, ensuring CAPA completion, production of Quality Metrics and Key Performance Indicators (KPIs).
· Log Product Complaints (PC) received by UK Safety and forward to the appropriate Product Complaints Coordinator/ (PCC) Quality Team and act as back up to the UK Product Complaints Coordinator (PCC) as required.
· Review all Product Complaints received by the company and liaise with members of Medical, GCSP, UK Supply chain and Regulatory Affairs teams on appropriate course of action, if required.
· Support the UK and Ireland Medical Affairs Teams by tracking the implementation of Risk Management Strategies for aligned products as defined in the applicable EU-RMP.
· Train UK & Ireland Pharma staff and 3rd party service providers on safety processes, as required.
· Alert relevant UK and Irish business staff of selected human safety information (HSI) in a timely manner.
· Take ownership of the departmental processes and deliver on project work as required.
· Support the UK LOC Safety Submission Specialists regarding Clinical Reporting queries and processes.
· Degree in pharmacy, pharmacology, relevant life science qualification or medically related degree, with a good understanding of medical and drug terminology;
· Excellent working knowledge of, and experience of working with, Pharmacovigilance regulations, with significant working knowledge in Pharmacovigilance methodology;
· Demonstrated understanding of the legal and ethical issues affecting the provision of information, including the ABPI Code of Practice and Medicines Act;
· Proven experience in negotiation and influencing internal and external stakeholders;
· Ability to assimilate and interpret information relating to the field of drug safety;
· Ability to present information clearly and logically, both orally and in written form;
· Ability to prioritise and organise workload, for oneself and others and think clearly under pressure and time constraints;
· Good understanding of commercial business objectives and external healthcare & Pharmacovigilance environment;
· Experience of involvement in external regulatory inspections and audits;
· Experience of working in a customer focused environment desirable;
· Computer literate.