Consumer Safety Science Specialist
2 weeks ago
Job Purpose
As a Consumer Safety Science Scientist at Haleon, you will be responsible for ensuring that adverse events and other safety information are efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements.
Key Responsibilities
- Perform signal detection activities to identify, assess, and escalate signals appropriately for designated products.
- Provide product safety input on cross-functional teams and support the central labelling team in maintaining product information for assigned products.
- Produce accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
- Author the safety contribution to regulatory submissions for new products, formulations, or indications, or support license renewal documentation.
- Provide safety input into development programs involving all product types, including clinical studies, real-world evidence, post-authorisation safety studies, pharmaco-epidemiological studies, sensory studies, and associated documentation.
- Assist in implementing risk minimisation strategies in relevant documents such as umbrella branding assessments and product labelling.
- Assist in producing regulatory supporting documentation for labelling updates.
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
Qualification:
A degree in Biomedical or Healthcare-related specialty is required.
Knowledge & Experience Required:
- 10+ years of experience in a related field.
- Basic knowledge in causality assessment and methodologies applicable to safety evaluation and risk management activities.
- Basic knowledge of the assigned therapeutic area and related disciplines.
- Basic knowledge of relevant regulations for all product types.
- Sound knowledge of medical and drug terminology.
- Competent medical writing skills.
- Sound computing skills.
Why Haleon?
Haleon is committed to creating an inclusive environment that celebrates our unique perspectives and promotes fair and equitable outcomes for everyone. We strive to create a workplace where your authentic self belongs and thrives.
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