Reference Number: JO-2002-446967
PV Specialist Manager
Rate: Negotiable
Job Type: Contract
Location: Maidenhead

PV Specialist Manager
6 Month Contract
Maidenhead based opportunity of 1 days home working flexibility
Offering up to 300 Per Day via Umbrella

Clinical Professionals is working with an ever-expanding pharmaceutical organisation whose specialism is vaccines. An opportunity has arisen for a PV Specialist Manager to join their established team on a 6-month contract basis, based from their Maidenhead office. Within this position you will be responsible for the processing of adverse event reports for in licensed products. The ideal candidate will have prior experience working in a CRO environment who has clinical trial case management.

Job Responsibilities include;

– Perform case management activities in relation to in-licensed products in compliance with pharmacovigilance agreements and regulatory requirements; including case processing, follow up activities, regulatory submissions, reconciliations, and review of pharmacovigilance agreements
– Support as a case management subject matter expert
– Attend clinical trial team calls from an operation PV perspective
– Propose and implement improvement and optimisation of case management processes. Author, review and input into procedural documents. Assist with training activities
– Handle and resolve single case processing queries and issues relating to end to end case processing from clinical and post marketing settings from the case processing vendor and other stakeholders

Candidate Requirement include;

– Life Sciences degree or the equivalent
– Up to 5 years Pharmacovigilance experience
– In depth knowledge of industry regulations, guidelines and drug safety practices
– Knowledge of global safety databases
– Prior CRO knowledge would be advantageous

If this position is of interest to yourself please call Sophie at Regulatory Professionals on 0118 952 2797 or alternatively forward your up to date CV to sophie@regulatoryprofessionals.com.