Senior Safety Science Specialist – Pune
Category: Clinical
Job ID: 255816
Location: Pune, India
About the Role
The Senior Safety Science Specialist is responsible for supporting end-to-end clinical safety and pharmacovigilance operations across assigned products. This role manages the complete adverse event lifecycle, covering safety data from clinical trials as well as post-marketing environments. The position ensures timely, compliant, and high-quality processing of adverse events, expedited safety reports, and periodic safety submissions.
The specialist will work closely with global clients, regulatory authorities, and internal project teams, providing expert safety oversight, case processing excellence, and operational support. This role requires adherence to international regulatory standards, including GCP, ICH, and global pharmacovigilance guidelines.
Key Responsibilities
Adverse Event (AE) and Safety Case Management
Manage receipt and processing of all AEs from spontaneous sources and clinical trials.
Perform accurate data entry, case assessment, and database tracking.
Review cases for completeness, medical accuracy, and expedited reporting requirements.
Write high-quality patient narratives and code events using MedDRA.
Confirm listedness against appropriate product labeling for marketed products.
Identify missing or clinically significant information and ensure timely follow-up.
Submit expedited safety reports to clients, regulatory bodies, ethics committees, investigators, and relevant stakeholders within required timelines.
Safety Reporting and Documentation
Manage and maintain adverse event tracking systems and project documentation.
Assist in the preparation and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) such as PSURs and DSURs.
Support database reconciliation with Data Management teams or sponsors.
Participate in the preparation of cumulative data for annual IND reports and related regulatory disclosures.
Quality, Compliance, and Oversight
Perform peer review and quality assessment of processed reports.
Contribute to preliminary signal detection, trend identification, and safety issue tracking.
Maintain comprehensive knowledge of SOPs, Work Instructions, and pharmacovigilance requirements.
Support CAPA processes, audits, and regulatory inspections.
Participate in updating Safety Management Plans, Reconciliation Plans, and safety-related documents.
Client and Cross-Functional Collaboration
Participate in client and project team meetings as required.
Guide, train, and mentor junior safety associates in case handling and reporting processes.
Assist with archiving safety study files upon project completion.
Minimum Qualifications
Candidates may qualify through a combination of education and relevant experience:
Non-degree: 4–5 years of relevant industry experience or 2 years of direct safety experience.
Associate degree: 3–4 years of relevant industry experience or 2 years of safety experience.
Bachelor’s degree (BS/BA): 2–3 years of relevant experience or 1–2 years of safety experience.
Master’s degree (MS/MA): 2 years of relevant experience or 1–2 years of safety experience.
PharmD: 2 years of relevant experience or 1–2 years of safety experience; residency/fellowship can be considered.
Preferred degrees: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related disciplines.
Experience Required
Hands-on experience processing AE/SAE cases, generating narratives, handling queries, and working within safety databases.
Experience in regulatory submissions and pharmacovigilance operations.
Knowledge of medical terminology, GCP, ICH guidelines, and global regulatory reporting requirements.
Ability to work independently with high attention to detail.
Skills and Competencies
Strong written and verbal communication skills.
Excellent organizational and time-management abilities.
Proficiency in MS Office and safety database systems.
Strong analytical and documentation skills.
Effective team collaboration and mentoring capabilities.
Work Environment
Office-based role with occasional travel (up to 5 percent) based on project or client requirements.
Gujarat :
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Canada |Quebec :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Croatia |Zagreb :
Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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