Job Title: Drug Safety Associate II (DSA II) – Pharmacovigilance
Location: Hyderabad, India (Work from Office)
Job Type: Full-Time
Company: SafeVig Solutions Pvt. Ltd.
About SafeVig Solutions
SafeVig Solutions is a growing Contract Research Organization (CRO) specializing in Pharmacovigilance, Clinical Research, Regulatory Affairs, and Safety Technology Services. We partner with pharmaceutical, biotechnology, and healthcare organizations to deliver high-quality, compliant, and innovative safety solutions that support global healthcare advancements.
Position Overview
SafeVig Solutions is seeking a Drug Safety Associate II (DSA II) to join its Pharmacovigilance team. The ideal candidate will be responsible for end-to-end Individual Case Safety Report (ICSR) processing, ensuring high-quality case management, regulatory compliance, and timely delivery of safety data. This role offers an excellent opportunity to contribute to global drug safety operations while working in a collaborative and quality-focused environment.
Key Responsibilities
Perform end-to-end ICSR case processing activities.
Conduct case intake, data entry, MedDRA coding, narrative writing, and medical assessment support.
Process cases received from spontaneous, literature, clinical trial, solicited, and other safety reporting sources.
Ensure compliance with client requirements, SOPs, regulatory guidelines, and pharmacovigilance standards.
Support literature surveillance and safety data review activities.
Maintain quality standards and achieve assigned productivity targets.
Participate in quality reviews, audits, inspections, and process improvement initiatives.
Collaborate with project teams to ensure timely and accurate client deliverables.
Support pharmacovigilance operations and contribute to continuous improvement programs.
Required Qualifications
M.Pharm, Pharm.D, B.Pharm, Nursing, Life Sciences, Biotechnology, or a related healthcare discipline.
Strong understanding of Pharmacovigilance principles and drug safety processes.
Knowledge of global regulatory requirements and safety reporting standards.
Excellent analytical and problem-solving abilities.
Strong written and verbal communication skills.
Ability to manage multiple priorities while maintaining quality and compliance.
Experience Requirements
2–5 years of experience in Pharmacovigilance.
Hands-on experience in ICSR case processing.
Experience handling adverse event reporting and safety data management activities.
Exposure to global pharmacovigilance processes and regulatory environments is preferred.
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