Pharmacovigilance Associate

Recruiter
Axess Ltd
Location
Essex
Posted
11 Jan 2018
Closes
10 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
An excellent opportunity for a PV professional to join the European HQ of a specialist pharma company and work on clinical and post marketed case processing as well as narrative writing across a wide ranging portfolio.

BACKGROUND

Niche pharmaceutical company based in London

Collaborative working environment.

Key orphan drugs

Excellent pipeline of products in development

Excellent public transport links and attractive location

PRIMARY DUTIES

- To be responsible to the Pharmacovigilance Manager for day-to-day ICSR processing of the reports directly from the UK and Ireland
- Prioritisation of individual case safety report processing, to identify those cases requiring to be processed to meet regulatory time lines
- Assists in ICSR compliance management, weekly/monthly data reconciliation and vital records archiving. Ensure that all the case processing reports are documented and stored according to company SOPs and WI or local conventions
- To assist with ARGUS database other activities and also collaborate with other European offices
- Ensure all the ICSR follow up activity processes actioned per Global SOPs/WIs
- Report adverse events associated with the use of company's marketed products to the pharmacovigilance and medical information departments as per company SOPs
- Adheres to and operate within the company guidelines and APBI Code of Practice appropriate to job role

QUALIFICATIONS / EXPERIENCE REQUIRED:

- Experience in pharmacovigilance processes and data entry including the knowledge of ARGUS database
- Experience in handling adverse events/reactions from clinical trials to post marketing level in accurately and efficiently in timely manner, in compliance with regulatory requirements
- Strong interpersonal skills

Benefits:

Comprehensive benefits package

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-7012

Only candidates with EU work authorisation will be considered.

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market