consumer safety senior scientist

Job Title: Consumer Safety Science – Senior Scientist

Location: Remote – Occasional travel the Weybridge

Contract: 12 months

Hours: 37.5 hours per week

Rates: £400 p/d

Job Description

SRG are looking for a consumer safety senior scientist for a leading consumer healthcare brand based in Weybridge. As part of the role, you will be responsible for ensuring that adverse events and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements. As well as performing signal detection activities to identify, assess and escalate signals appropriately, for designated products. Providing product safety input on cross-functional teams. Supporting central labelling team in maintenance of product information for assigned products. You will also be responsible for mentoring and coaching other CS Science Scientists.

Duties and Responsibilities

• Perform signal detection for assigned products using available methodologies (e.g. signal management tool, literature review, individual case awareness tool), with some level of support from more senior personnel, as necessary.
• Use appropriate sources of information and database searches to retrieve relevant data for exploration / evaluation of safety signals. Communicate, escalate, and document outcomes of signal detection process.
• Produce accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data with some level of support from more senior personnel, as necessary.
• Author the safety contribution to regulatory submissions for new products, formulations or indications, or in support to license renewals.
• Provide safety input into development programs involving all product types, including clinical studies, real-word evidence, post-authorisation safety studies, pharmaco-epidemiological studies, sensory studies and associated documentation.
• Assist in implementation of risk minimisation strategies in relevant documents such as umbrella branding assessments and product labelling.
• Produce regulatory supporting documentation for labelling updates and present labelling recommendations at relevant forums.
• Assist in production of safety component of Safety Data Exchange Agreements.
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
• May represent Consumer Safety Science on cross-functional project teams and contribute to process improvement initiative within Consumer Safety.
• Mentor and train safety scientists on own area of expertise in relation to product safety.

Experience and Qualifications

• Degree in Biomedical or Healthcare-related speciality.

Competencies and skills

• Sound knowledge in causality assessment and methodologies applicable to safety evaluation & risk management activities
• Good understanding of the assigned therapeutic area and related disciplines (e.g. statistics)
• 5 years or more experience in a similar role
• Decent knowledge of relevant regulations for all product types
• Sound knowledge of medical and drug terminology
• Strong medical writing skills
• Sound computing skills
• Uses range of sources and methods to gather information, identifies and proposes potential solutions for addressing issues and makes decisions with consultation.
• Demonstrates initiative in performing assigned tasks, prioritises own workload and coordinates tasks effectively with other team members.
• Able to meet multiple deadlines successfully with attention to detail and quality.
• Demonstrates confidence in own ability, integrity and professionalism in interactions with colleagues.
• Builds effective working relationships and responds to needs of stakeholders in relation to safety issues.
• Takes account of the internal and external environment when considering safety issues.