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Consumer Safety Science Scientist
Haleon
·
13-15 years
Vijayawada, Visakhapatnam, Guntur + 1 more
1 vacancy
Consumer Safety Science Scientist
Haleon
posted 16hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
The CS Science Scientist is accountable for the continued safety monitoring and safety evaluation of assigned products in clinical development and/or post-marketing setting.
- Ensure 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.
- Perform signal detection activities to identify, assess and escalate signals appropriately, for designated products.
- Provide, with some support, product safety input on cross-functional teams. Support central labelling team in maintenance of product information for assigned products.
Key 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.
- 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-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, with guidance from more senior personnel.
- Assist in producing regulatory supporting documentation for labelling 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 initiative within Consumer Safety.
Qualifications and skills Essential
- Degree in Biomedical or Healthcare-related speciality
Preferred
- Basic knowledge in causality assessment andmethodologies 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.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Saturday
No travel
Day Shift
Haleon Benefits
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Employee Assistance Program Personal Development and Training Employee Friendly Policies Health Insurance Maternity and Paternity Leave
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