Executive – Regulatory Affairs
Sun Pharma
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Job Description
 Location: Pune, Maharashtra, India
Job Requisition ID: 254803
Job Type: Full-Time
Remote Type: Hybrid
Introduction
The Assistant I PSS will support Clinical Safety and Pharmacovigilance (PSS) operations for products, including management of adverse events from clinical trials and post-marketing settings. This role ensures timely and accurate processing of safety data, adherence to regulatory requirements, and high-quality service to internal and external clients.
Role & Responsibilities
- Perform case intake and triage of incoming safety information from various sources.
- Data entry of safety data into adverse event tracking systems.
- Write patient narratives and accurately code adverse events using MedDRA.
- Assist in listedness assessments against product labels, if applicable.
- Generate queries and collect missing or discrepant information in consultation with medical staff.
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and other stakeholders within agreed timelines.
- Assist in processing and submission of expedited and periodic reports to global regulatory agencies.
- Reconcile databases as required and maintain supporting documentation.
- Ensure compliance with Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Build and maintain effective PSS relationships across functional units.
- Support overall compliance of operations with regulatory requirements.
- Perform other duties as assigned.
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Educational Qualification
Education:
- Non-Degree with 6 months – 1 year of safety experience, OR
- Associate Degree with 0–6 months of safety experience, OR
- BS/BA with 0–6 months of safety experience, OR
- MS/MA or PharmD with 0 years of safety experience.
Relevant Disciplines: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
Experience:
- Safety experience includes processing AE/SAE reports, generating narratives, queries, working with safety databases, and regulatory submissions.
- Relevant experience may include pharmaceutical, biotechnology, or CRO industry roles in Medical Affairs, Clinical Data Entry, Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
Skills & Competencies:
- Attention to detail and accuracy.
- Team player with strong written and verbal communication skills.
- Proficiency in MS Office and standard office equipment.
- Ability to handle and proofread numerical data.
Location
Nanakramguda, Hyderabad, India
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