Pharmacovigilance (PV) Officer

Pharmacovigilance (PV) Officer sought by a PV Consultancy delivering drug safety and medical Information services across CRO, Generic and Global Pharma Companies. This is a Contract Position, initially for 3 months.

This is a pivotal role where you will ensure Case Reports are managed successfully within agreed timelines and regulatory and client procedures. This is a wide ranging role across multiple clients and will provide the successful candidate with a significant variety of tasks and experiences.

Responsibilities include triaging of adverse events and ADR reports, use of the PV databases to record the same from post-marketing and clinical sources. You will submit AEs and ADRs to regulatory bodies meeting statutory timelines. You will be involved in EudraVigilance reporting and will regularly perform literature searches for ICSRs and relevant safety data.

You will also review SmPCs comparing and standardising text and update the client's products to Medicinal Product Dictionaries (EVMPD).

You are likely to be in the early stages of your PV career and will have at least 1 year of quality Pharmaceutical or Life Science PV experience. You will be great at multitasking, managing time and tasks effectively and will be used to working on your initiative always looking for opportunities to excel and provide great customer service.

To be successful you will have a high standard of written and spoken English, be a great networker, confident dealing with clients and comfortable writing reports and generating meeting minutes. You will also be familiar with working with and improving both internal and external SOP's and be willing when necessary to share issues and escalate challenges and problems at an early stage.