PVG Associate

Major Duties and Responsibilities

• Receive and process adverse events (AEs) received from all sources (health authorities, consumers,

healthcare professionals, literature articles etc.).

• Perform case triage and duplicate checks of all cases received, identifying and categorising

suspected AEs.

• Perform data entry of AEs onto the safety database and write case narratives

• Perform expedited reporting decisions in conjunction with senior staff.

• Handling of information and results of global literature search

• Update SOPs

• Report cases to relevant regulatory authorities

• Perform appropriate follow-up of cases

• Track cases in the appropriate database

• Adhere to internal and strict external timelines

• File and archive paper and electronic documents according to departmental conventions

• Liaise with external parties including medical contractor and translation companies as required.

• Receive and answer technical query calls from customers and healthcare professionals.

• Prepare safety reviews and other aggregate reports for designated products

• Present and discuss safety findings at monthly pharmacovigilance team meetings

• Maintain knowledge of current pharmacovigilance legislation, guidelines and internal standard

operating procedures (SOPs)

• Deliver training presentations as required

• Receive, process and track Medical Information queries

• Immediate escalation of potential safety issues detected whilst performing allocated duties

• Perform any other tasks as required by the Pharmacovigilance Case Management and Medical Information Manager or Head of Pharmacovigilance, UKQPPV.

Competencies

Responsible for receiving, monitoring, assessing and evaluating information from healthcare providers and patients on the adverse effects of Rosemont products in use with a view to identifying information about potential new hazards and preventing harm to patients.

• Attention to detail

• Excellent time management skills and must be able to work to tight timelines

• Strong communication skills, both verbally and written.

• Self-starter and organized.

• Ability to build relationships in person and remotely

• 1-2 years working experience in pharmacovigilance preferred

• Experience with drug safety databases, preferably Veeva/Argus/ARISg is preferred

Knowledge and Experience

•Typical Years of Experience-0-2 Years Experience in a similar role.

•Minimum Expected Education- A bachelor’s in sciences/pharmacy/nursing degree or related field.