Clinical Safety Scientist

CK Group are recruiting for an 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:

• Authoring the SERM safety contribution to global regulatory submissions in partnership with the product physician.
• May respond to auditors/inspectors requests for information/additional information and completes corrective and preventative actions (CAPAs) within agreed timelines.
• Driving production of regulatory periodic reports and associated documentation and RMPs globally.
• Assist in authoring periodic regulatory documents (PSURs PBRERs , DSURs, licence renewal documentation) according to the agreed process and timelines.
• 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 in all correspondence.

Please note:

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

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