Consumer Safety Science Scientist

3+ years

Not Disclosed

Hyderabad

10 July 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company: Haleon

About Haleon: Haleon is a new world-leading consumer health company, committed to improving everyday health for billions of people. Our portfolio includes category-leading brands like Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum. Through a unique combination of deep human understanding and trusted science, we innovate and grow our global portfolio. Join us to be part of a culture we co-create, an environment we control, and a company we're building together.

Job Title: CS Science Scientist

About the Role:

The CS Science Scientist is accountable for the continued safety monitoring and evaluation of assigned products in clinical development and post-marketing settings.

Key Responsibilities:

Safety Evaluation:
- Ensure that adverse events and other safety information are efficiently evaluated.
- Complete safety reports accurately and timely to meet global compliance and regulatory requirements.
Signal Detection:
- Perform signal detection activities to identify, assess, and escalate signals appropriately for designated products.
Product Safety Input:
- Provide product safety input on cross-functional teams with some support.
Labeling Support:
- Support the central labeling team in maintaining product information for assigned products.

Responsibilities:

Perform signal detection for assigned products using methodologies like signal management tools, literature reviews, and individual case awareness tools with some level of support.
Use information sources and database searches to retrieve relevant data for evaluating safety signals.
Communicate, escalate, and document outcomes of the 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 support.
Author the safety contribution to regulatory submissions for new products, formulations, or indications, or support license renewal documentation, with strategic guidance.
Provide safety input into development programs involving clinical studies, real-world evidence, post-authorization safety studies, pharmaco-epidemiological studies, sensory studies, and associated documentation with guidance.
Assist in implementing risk minimization strategies in relevant documents such as umbrella branding assessments and product labeling.
Produce regulatory supporting documentation for labeling updates.
Assist in producing the safety component of Safety Data Exchange Agreements.
Maintain personal readiness for internal audits or regulatory inspections.
Represent Consumer Safety Science on cross-functional project teams and contribute to process improvement initiatives.

Qualifications and Skills:

Essential:

Degree in Biomedical or Healthcare-related specialty.

Preferred:

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 (e.g., statistics).
Basic knowledge of relevant regulations for all product types.
Sound knowledge of medical and drug terminology.
Competent medical writing skills.
Strong computing skills.
Ability to use various sources and methods to gather information, propose potential solutions, and make decisions with consultation.
Effective relationship-building and responsiveness to stakeholder needs regarding safety issues.
Ability to consider internal and external environments when addressing safety issues.

Why Haleon?

At Haleon, our values and expectations are central to our culture. These include Patient Focus, Transparency, Respect, Integrity, Courage, Accountability, Development, and Teamwork. We strive for innovation, performance, and trust, and we seek candidates who demonstrate the following capabilities:

Operating at pace and making agile decisions using evidence and judgment.
Committed to delivering high-quality results, overcoming challenges, and focusing on what matters.
Continuously seeking opportunities to learn, build skills, and share knowledge.
Sustaining energy and well-being.
Building strong relationships and fostering honest and open conversations.
Budgeting and cost-consciousness.
Promoting Diversity, Equity, and Inclusion.

Haleon embraces a diverse workforce, creating an inclusive environment that celebrates unique perspectives, generates curiosity, and promotes fair and equitable outcomes. We strive to respect each other, listen to different viewpoints, support our communities, and create a workplace where your authentic self belongs and thrives.

We believe in agile working for all roles. If flexibility is important to you, explore opportunities with our hiring team.

Equal Opportunity Employer: Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other protected class.

Note: For US Licensed Healthcare Professionals or defined Healthcare Professionals, Haleon may be required to capture and report expenses incurred on your behalf if you are afforded an interview, to ensure compliance with US Transparency requirements.

Apply: Find out what life at Haleon is like at www.haleon.com/careers