Haleon has announced an opening for a CS Writing Scientist in Hyderabad for candidates with a degree in a biomedical or healthcare-related speciality and relevant experience in clinical, safety or regulatory document writing.
This is a strong opportunity for professionals seeking careers in pharmacovigilance, aggregate report writing, drug safety, safety science and regulatory medical writing. The position focuses on preparing high-quality safety documentation used for local, regional and global regulatory submissions.
The CS Writing Scientist will support the Consumer Safety function by authoring and coordinating documents such as PBRERs, DSURs, Risk Management Plans, Medical Device PSURs and other regulatory safety reports.
About the CS Writing Scientist Role
The role is primarily focused on safety and regulatory writing rather than general medical content writing.
The selected candidate will prepare safety writing deliverables from initiation through completion, including planning, authoring, data analysis, coordination with contributing functions and quality control.
The CS Writing Scientist will also support safety scientists with benefit-risk assessments, signal evaluations, safety risk management plans, regulatory submissions and aggregate safety reports.
Key Responsibilities
Major responsibilities for the Haleon CS Writing Scientist position include:
- Plan, author and prepare safety writing deliverables for regulatory purposes.
- Coordinate assigned safety writing projects from initiation through completion.
- Perform quality control of safety documents and ensure deliverables meet required standards.
- Maintain current product safety information and ensure its consistent use across regulatory reports.
- Search appropriate databases and information sources to obtain relevant safety data.
- Review published scientific and medical literature for potential safety signals.
- Incorporate relevant literature findings into periodic and aggregate safety reports.
- Serve as the principal owner and coordinator for assigned safety writing deliverables.
- Ensure safety documents comply with applicable company procedures and regulatory requirements.
- Develop safety summaries for internal and external communication.
- Support documentation required for product labelling updates.
- Assist Consumer Safety Science teams with routine signal detection activities, including review of Individual Case Safety Reports (ICSRs).
- Maintain readiness for internal audits and regulatory inspections.
- Contribute to Consumer Safety process-improvement initiatives with appropriate guidance.
Safety & Aggregate Reports
One of the most important aspects of this Haleon safety writing job is exposure to multiple types of pharmacovigilance and regulatory safety documentation.
The CS Writing Scientist may produce or contribute to:
- PBRER – Periodic Benefit-Risk Evaluation Report
- DSUR – Development Safety Update Report
- Safety Risk Management Plans
- Medical Device Periodic Safety Update Reports
- Cosmetic Undesirable Effects Reports
- Canadian Annual Reports
- US Periodic Adverse Drug Experience Reports
- Clinical Overviews and Summaries
- Benefit-Risk Assessments
- Safety Signal Evaluations
- Regulatory Safety Submissions
The position therefore aligns particularly well with candidates who already have experience in aggregate reporting, pharmacovigilance medical writing or regulatory safety writing.
Qualification
Haleon specifies the educational requirement as:
Degree in a Biomedical or Healthcare-related speciality
The job description does not provide a restrictive list of individual degrees. Candidates should therefore assess whether their academic qualification meets Haleon’s definition of a biomedical or healthcare-related speciality before applying.
Experience Requirements
The job description does not specify a fixed number of years of experience.
However, Haleon specifically seeks candidates with:
Prior experience authoring clinical, safety or regulatory documents, such as PBRERs.
Therefore, this vacancy should not be presented as a confirmed fresher opportunity unless Haleon separately confirms fresher eligibility.
Candidates with previous exposure to pharmacovigilance aggregate reports, safety writing, regulatory writing or clinical documentation are more closely aligned with the stated requirements.
Skills Required
Candidates should have strong capabilities in the following areas:
Safety Writing | Pharmacovigilance | Aggregate Reporting | PBRER | DSUR | Risk Management Plans | Regulatory Writing | Safety Signal Evaluation | MedDRA | Medical Terminology | ICSR Review | Literature Review | Benefit-Risk Assessment | Scientific Writing
Haleon additionally requires:
- Fluency in English.
- Strong writing and editorial skills.
- Experience authoring clinical, regulatory or safety documents.
- Sound understanding of MedDRA terminology.
- Familiarity with medical terminology.
- Ability to interpret and logically present scientific and safety data.
- Ability to prioritize multiple projects and meet deadlines.
- Good presentation skills.
- Adaptability in a fast-moving environment.
- Sound computing skills.
Is This Pharmacovigilance or Medical Writing?
This role sits at the intersection of Pharmacovigilance, Safety Science and Regulatory/Medical Writing, but its strongest functional alignment is with pharmacovigilance safety writing and aggregate reporting.
The responsibilities include PBRERs, DSURs, risk management plans, signal evaluations, ICSR review, literature surveillance, benefit-risk assessment and other regulatory safety documentation.
For job categorization on PharmaBharat, this vacancy is therefore highly relevant under:
Pharmacovigilance / Aggregate Reporting / Medical Writing / Drug Safety
Why Consider This Haleon Opportunity?
The position provides exposure to global consumer safety documentation and multiple regulatory safety report types.
Candidates can potentially strengthen their expertise across aggregate reporting, signal management, benefit-risk evaluation, literature surveillance, safety science and regulatory writing while collaborating with Consumer Safety professionals.
The role also provides exposure to safety requirements across different product categories, including pharmaceutical, medical device and consumer healthcare products.
How to Apply
