Pharmacovigilance Officer

Location: Hybrid / Paignton, UK
Job type: Permanent / Full-time
Sector and subsector: Science | Quality & Validation
Annual Salary range: from £30,316.00 to £38,584.00

Support the general maintenance of the pharmacovigilance (PV) system (drug safety system) for TP products – ensures patient safety by monitoring and evaluating the clinical use of products

Assist with ensuring TP Ltd is in compliance to UK & international PV legislation

At TP we have our own special kind of chemistry. Our heritage spans over 50 years with a track record of manufacturing essential medicines across the UK and beyond. With backing from an investment partner we are now forging a new path in the private sector.

We are a growing and ambitious business and with this comes opportunities for our people. At TP, we are going places. A career with us means a career helping save lives. We bring skills of all levels and experiences together; not all of our people begin their working lives in pharma. Together we can make lives better.

• Putting Health & Safety first in how you work, making sure your own actions and decisions support a safe working environment
• Identifying and promptly reporting Health & Safety hazards and incidents
• Following all Health & Safety procedures and challenging or escalating anything that could present a risk to people, product or site operations.

• Support management of the company Pharmacovigilance System Master File which details all aspects of the PV system and its interface with other company departments
• Manage the ASPR work flow process from downloads to review, triage & data entry into the company safety database
• Manage the literature searching activity & associated actions
• Assist with the management of PV Agreements with licensing partners, distributors and wholesalers both nationally and overseas
• Further develop the PV training programme
• Deputise upwards for the Trainee PV Specialist at PV Group meetings, PV audits, Competent Authority PV Inspections and other meetings as required

The role sits within the Pharmacovigilance Team as part of the wider Regulatory Affairs section of the company. It directly reports to the Trainee PV Specialist for work activity and is line managed by the Head of Regulatory & Compliance who also acts as Deputy QPPV. The role of QPPV is outsourced to a PV consultancy company, Pharsafer Associates Ltd.

The Regulatory Affairs Team is split into a regulatory/licensing section, pharmacovigilance and artwork design. The department also consists of the quality system section.

The whole team works closely together and creates a supportive, flexible, happy environment that is committed to delivering quality outcomes against targets.

• Evaluate, process, follow-up, monitor and trend adverse events cases involving licensed and unlicensed TP products to national & international safety databases
• Assist in developing, implementation and maintenance of procedures for all aspects of the PV system including new PV processes for new export opportunities overseas
• Assist with managing and maintaining PV Agreements with approved distributors and/or 3rd party customers
• Review clinical and toxicological reports generated by industry experts and clinical/non-clinical papers arising from literature searches
• Day to day running of the literature screening process where weekly literature searches are undertaken via scientific databases to identify any emerging safety trends, safety data, adverse events etc.
• Day to day running of the ASPR downloads, including MHRA portal & L2A Eudravigilance where appropriate, screening & triage within the signal detection process
• Generate line listings for safety reviews & reports where necessitated
• Maintain the PV safety database that holds critical patient and product safety data of TP products in clinical use
• Maintain PV metrics for ASPR & literature searching activities & generate timely reports detailing compliance of the system

• Excellent communication and interpersonal skills
• Experience of presenting complex information to large groups
• Excellent…