About the Role

- 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

Role 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 transparent 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-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 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.

Why you

Basic Qualifications:

- Degree in Biomedical or Healthcare-related specialty
- 8+ years of experience is required
- 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.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Consumer Safety Science Scientist (Hyderabad)
🏢 Haleon
📍 Hyderabad