Specialist I – Clinical Safety / Pharmacovigilance
Location: Bangalore, India
Job Type: Full-Time
Category: Clinical / Pharmacovigilance
Experience Required: 1–3 Years (depending on qualification)
Job ID: 26731
Overview
An excellent opportunity is available for a Specialist I in Clinical Safety and Pharmacovigilance. This role focuses on end-to-end adverse event case processing and safety data management across clinical trials and post-marketing settings. The position plays a critical role in ensuring regulatory compliance, high-quality safety reporting, and timely submission of adverse events to global regulatory authorities and stakeholders.
Key Responsibilities
The role involves managing the intake, processing, and reporting of adverse events from multiple sources, including clinical trials and spontaneous reports. You will perform accurate data entry into safety databases, review cases for completeness and regulatory compliance, and prepare detailed patient narratives while coding adverse events using MedDRA.
You will assess listedness, identify missing clinical information, and ensure appropriate follow-up activities. Timely submission of expedited safety reports, including Serious Adverse Events (SAEs), to regulatory authorities, clients, and ethics committees is a key responsibility.
Additionally, you will support periodic safety reporting activities such as PSURs, DSURs, and Annual IND reports, along with database reconciliation and maintenance of safety tracking systems. Participation in signal detection, trend analysis, and preparation of safety metrics and project reports is also expected.
The role requires collaboration with cross-functional teams, contribution to audit readiness, CAPA activities, and maintenance of safety documentation including Safety Management Plans. You may also support training and mentoring of junior team members and participate in client and project meetings.
Educational Qualifications
Degree in Life Sciences, Pharmacy, Nursing, Medical Sciences, or a related field is preferred. Candidates with BSc, BPharm, MPharm, PharmD, or equivalent qualifications are encouraged to apply.
Experience Requirements
Typically 1 to 3 years of pharmacovigilance or drug safety experience, including hands-on experience in AE/SAE case processing, narrative writing, and safety database usage. Equivalent experience in clinical research, regulatory affairs, or related domains may also be considered.
Required Skills and Competencies
Strong understanding of pharmacovigilance processes and adverse event reporting
Knowledge of global regulatory requirements and ICH-GCP guidelines
Proficiency in medical terminology and safety coding (MedDRA)
High attention to detail with strong data accuracy skills
Good analytical, communication, and presentation abilities
Ability to work independently as well as collaboratively within teams
Familiarity with safety databases and MS Office tools
Work Environment
Office-based role with occasional travel requirements (up to 5%) based on project needs.
Why Join
This position offers a strong foundation for building a career in pharmacovigilance and clinical safety. You will gain exposure to global safety reporting standards, regulatory frameworks, and advanced case processing systems while contributing to patient safety and drug development initiatives.
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