Drug Safety / Pharmacovigilance Associate Chippenham, South West England, England
Job description
Role Brief
Drug Safety / Pharmacovigilance Associate
COMPANY OVERVIEW
Focuses on the marketing of consumer healthcare brands, OTCs, POMs and Devices. They hold marketing rights to around 80 brands including pharmaceutical and medical device.
DEVELOPMENT OPPORTUNITY
Working across the full lifecycle of drug development and across a broad portfolio of products will broaden your end-to-end safety experience. The role will also provide an opportunity to develop and / or strengthen your experience of key safety report writing including PSURs, DSURs.
ROLE AND RESPONSIBILITIES
Direct Reports: None
Team: PV Department
Reports to: Senior Patient Safety Manager or Senior PV Scientist/Deputy QPPV
Primary Function:
This is an excellent opportunity for graduate with some pharmacovigilance/vigilance experience to develop their career in a growing organisation where there is lots of opportunity to develop and expand their knowledge and experience. An ideal candidate will be looking to take responsibility to shape, develop and own a system and associated processes. It’s a fast-paced environment with scope to work on multiple projects and requires a flexible and resourceful individual.
Key Accountabilities:
· Processing ICSRs in ARISg database involving all products (in details: case triage including seriousness and listedness, data entry and QC, causality assessment, submission to NCAs, follow-up, tracking and filing of the reports)
· Weekly literature review
· Data reconciliation with partners and affiliates
· Follow company’s SOPs, knowledge of GVP modules, especially VI and ICH (E2B)
· May be involved in projects which include signal management, PSUR, and CER.
Essential Technical Skills:
· Life Sciences graduate or proven vigilance experience.
· 6- 12 months experience in PV/medical device vigilance, Pharmacy, compliance, clinical trials or similar is desired.
· Knowledge of GVP modules, especially VI and ICH (E2B)
Key Behaviours:
· Good attention to detail.
· Ability to work Independently with supervision, accountable, confident, team player with ability to build relationships across the business.
Location / Travel:
2 days per week in office. Office is 2 minutes from local train station. Once fully trained, there may be flexibility to attend the office for 1 day per week.
Remuneration / Package:
Basic: Competitive basic salary offered
Package: Attractive package including, pension, bonus scheme, life assurance and medical cover.
Applicants must be eligible to work in the UK. No sponsorship will be provided by the client.
For more information on how to apply, please contact: 01737 948899.
Direct email:
Job Type: Full-time
Salary: £40,000.00-£50,000.00 per year
Benefits:
- Company events
- Private medical insurance
- Sick pay
- Wellness programme
- Work from home
Schedule:
- Monday to Friday
Supplemental pay types:
- Bonus scheme
Ability to commute/relocate:
- Chippenham: reliably commute or plan to relocate before starting work (required)
Education:
- Bachelor's (preferred)
Work Location: Hybrid remote in Chippenham
Reference ID: GPV
