Pharmacovigilance Data Associate
2 weeks ago
POSITION DETAILS
Title: Pharmacovigilance Data Associate
Upward Reporting: Head of Quality and Drug Safety
Position Type: Permanent, ongoing with a 6-month probation period
Location: London, UK
Hours: Regular working hours are Monday to Friday from 9.00am to 5.30pm, with two days office attendance and three days remote working.
Travel: Some international travel may be required
ABOUT THE COMPANY
A global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.
DESCRIPTION OF THE ROLE
- Assist the safety team in handling safety data (including adverse events) in compliance with regulatory requirements and Company SOPs
- Case processing
- MedDRA coding of safety events to the current version as required
- Data entry in the Pharmacovigilance Database
- Maintain the Pharmacovigilance Database
- Monitoring adverse events (AEs) arriving via EEDR
- Produce safety data, in the required format for signal detection and for inclusion in periodic aggregate reports
- Provide safety data, in the required format, to the regulatory department for submission to the regulatory authorities
- Assist in the ongoing improvement of the pharmacovigilance system
- ICSR and SUSAR reporting via EVWEB (upon training); Medical and Scientific Literature search
ESSENTIAL REQUIREMENTS FOR ROLE
- Life science degree
- Working knowledge of GVP guidelines
- Working knowledge of ICH GCP guidelines
- At least 3 years’ experience in pharmacovigilance compliance/quality fields
- Excellent attention to detail
- High level of computer literacy
- Ability to plan, organise and follow up
- Track and plan clinical activities to meet agreed timelines
- Maintain a current awareness of pharmacovigilance requirements
- Effective verbal and written communication in individual and group settings
- Ability to create and maintain relationships with internal/external customers
- Ability to work in a team environment
- Problem-solving skills
- Effective time management of multiple tasks
- Inquisitive mind
- European languages an advantage (German/Italian/French)
WHAT’S ON OFFER:
- A competitive salary with benefits.
- The chance to contribute and be part of a team whose work directly benefits healthcare and strives to improve people’s lives.
- A real hands-on opportunity to gain a high degree of commercial exposure.
- The chance to work alongside world-leading scientific experts.
- Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.
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