Overview

Reference Number: JO-2207-496163
Safety Physician
Rate: Negotiable
Job Type: Permanent
Location: Watford

Safety Physician

Watford

Cpl Lifesciences are looking for a Safety Physician to join an exciting pharmaceutical company on a permanent basis.

The Safety Physician is responsible for the scientific evaluation of safety information and the continuous monitoring of the benefit-risk profile of assigned products throughout all stages of the product lifecycle and to ensure compliance with global legislation and guidelines that govern the development, registration and commercialisation of medicines

Role:

Medical/scientific review of ICSRs/aggregate reports for assigned products when required

Author drug safety reports (DSURs, Clinical Overview, Benefit-Risk reports)

Respond to regulatory authority/healthcare professionals queries for assigned products

Perform signal detection and evaluation and present analysed signals to safety committees

Participate in cross-functional safety review teams for assigned products

Working closely with the clinical teams, review and provide input into safety sections of

study related documents (study synopsis and protocols, IB, ICF, CRFs SAEs forms, CSR ISS)

Contribute to the development and implementation of Risk Management Plans including

(Risk Minimization Plans/Risk Evaluation and Mitigation Strategy) for assigned clinical

products

Contribute to the conduct of Health Hazard Assessment of product quality issues with safety

implication for products under development

Support GCP/ GvP audits, inspection and CAPA management including effectiveness

evaluation.

Liaise and collaborate with other key stakeholders

Support assessment and implementation regulatory intelligence

Support organisational initiatives in driving operational excellence and compliance

Support product labelling activities, including monitoring of EEA /FDA and other regulatory

authority websites for information that may necessitate a label change

Support development and maintenance of standard operating procedures, polices and,

training of PV and non PV staff to meet global regulations guidelines and organizational

standards

Education and/or Experience:

Medically Qualified

Minimum of 5 years of drug safety experience in a biotechnology or pharmaceutical

company environment.

Good understanding of drug development process and drug safety regulatory requirements

(EU, US as well as ICH and GCP Guidelines )

Experience in safety of drug development, registration and commercialisation would be an

advantage

Experience in authoring safety reports, medical review, risk management, and signal

management

To apply, please send your CV to Aneesha Buck aneesha.buck@cpl.com

Upload your CV and any other relevant file.
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