Consumer Safety Science Specialist
3 weeks ago
Job Purpose
We are seeking a highly skilled Consumer Safety Science Scientist to join our team at Haleon. The successful candidate 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.
Key Responsibilities
- Perform signal detection for assigned products using available methodologies, 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.
- May author the safety contribution to regulatory submissions for new products, formulations, or indications, or support license renewal documentation, with strategic guidance from more senior personnel.
- With guidance, provide safety input into development programs involving all product types, including clinical studies, real-world evidence, post-authorization safety studies, pharmaco-epidemiological studies, sensory studies, and associated documentation.
- Assist in implementation of risk minimization strategies in relevant documents, such as umbrella branding assessments and product labeling, with guidance from more senior personnel.
- Assist in producing regulatory supporting documentation for labeling updates.
- May assist in production of safety component of Safety Data Exchange Agreements.
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
- With guidance, represent Consumer Safety Science on cross-functional project teams and contribute to process improvement initiatives within Consumer Safety.
Qualification:
Degree in Biomedical or Healthcare-related specialty
Knowledge & Experience Required:
- 10+ years of experience
- Basic knowledge in causality assessment and methodologies applicable to safety evaluation & risk management activities
- Basic knowledge of the assigned therapeutic area and related disciplines (e.g., statistics)
- Basic knowledge of relevant regulations for all product types
- Sound knowledge of medical and drug terminology
- Competent 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.
- Builds effective working relationships and responds to needs of stakeholders in relation to safety issues.
- Takes account, with guidance, of the internal and external environment when considering safety issues.
Why Haleon?
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity, along with Courage, Accountability, Development, and Teamwork. As Haleon focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgment to balance pace, rigour, and risk.
- Committed to delivering high-quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills, and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
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