Drug Safety

**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**:
**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.

**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