Clinical Safety Scientist

Austin Fraser; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job description

CK Group are recruiting for a Clinical Safety Scientist, to join a company in the pharmaceutical industry, on a contract basis for 6 months. This is a fully remote position.

Salary:

£555 per day Umbrella or £430.17 per day PAYE.

Clinical Safety Scientist Role:

To provide safety support and expertise with particular focus on medicines for the treatment and prevention of HIV. The key focus is on safety, evaluation and risk-management.

This position is responsible for signal detection, and evaluation activities for assigned products.

Further Responsibilities Include:

1. Authoring the SERM safety contribution to global regulatory submissions in partnership with the product physician.
2. May respond to auditors/inspectors' requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.
3. Driving production of regulatory periodic reports and associated documentation and RMPs globally.
4. Assist in authoring periodic regulatory documents (PSURs [PBRERs], DSURs, licence renewal documentation) according to the agreed process and timelines.
5. Assists in the update of investigator brochures.

Your Background:

Bachelors, or above, degree in Biomedical or Health Care related speciality.
Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation.
Competent medical/scientific writing skills.
Sound computing skills.
Knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.
Knowledge and experience of the principles of causality assessment and the evaluation of safety signals.

Company:

Our client is one of the largest global healthcare companies researching, developing and supplying innovative medicines, vaccines and healthcare products with their global headquarters in the UK. They invest around £1bn in research and development in the UK annually.

Location:

Fully remote.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence.

Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.