Pharmacovigilance Officer

at  Northumbria Pharma

COMPANY BACKGROUND

Northumbria Pharma is a dynamic and innovative, UK based pharmaceutical company. We specialise in the research, development, manufacture, licensing and marketing of unique and vital pharmaceutical products.
We are looking to appoint a Pharmacovigilance Officer to make a difference and to contribute to improving the lives of our patients.
At Northumbria Pharma we strongly believe in career development for all team members and we will help you to develop both professionally and personally to fulfil your potential.
We are located in a modern serviced building, with plenty of free on-site parking, good road links, and regular bus services from surrounding towns.

COMPETENCIES (KNOWLEDGE, SKILLS AND ATTRIBUTES)

• Excellent attention to detail
• High level of computer literacy
• Problem solving skills
• Effective time management of multiple tasks to meet agreed timelines
• Excellent verbal and written communication in individual and group settings, professional telephone etiquette and empathetic customer service skills.
• Ability to create and maintain relationships with internal and external partners
• Ability to work in a team with minimal supervision.
• Ability to work to tight project timelines.

QUALIFICATIONS

• Life science degree
• At least 2 years’ experience in pharmacovigilance (or related field)
• Working knowledge of GVP guidelines and data protection regulations

The pharmacovigilance officer will be responsible for the monitoring of safety profile of medicinal products and providing medical information to consumers and healthcare professionals. In accordance with company standard operating procedures and all applicable pharmacovigilance regulations and guidelines.

The Pharmacovigilance Officer will report to the PV Team Leader and the key responsibilities include:

• Screening of scientific literature for safety information;
• Providing medical information and handling costumers’ complaints;
• Collecting, collating and evaluating safety data (from all sources);
• AE and ICSRs handling, processing and submitting to regulatory agencies
• Writing and management of safety data exchange agreements;
• Performing reconciliation between companies’ partners
• Writing and maintenance of PSMF
• Providing support on safety and aggregate reports;
• Performing risk assessments for third parties and Companies PV system.
• Assisting in the preparation for inspections carried out by Regulatory bodies (e.g. MHRA).
• Screening of regulatory intelligence and safety variation requirements
• Preparing and reviewing SOPs, change controls, deviations and corrective actions and preventive actions (CAPA);
• To be familiar with all current Health and Safety requirements as well as with all in-house safety regulations.