Pharmacovigilance Officer – Veeda CR | Remote (Ahmedabad-based)
Location: Remote / Ahmedabad, India
Job Type: Full-Time, Permanent
Experience Required: 2–3 years in Pharmacovigilance or Clinical Safety
Industry: Pharmaceutical & Life Sciences | Clinical Research | Pharmacovigilance
About Veeda CR
Veeda Clinical Research is a leading Contract Research Organization (CRO) dedicated to advancing global healthcare through high-quality clinical research and pharmacovigilance services. We support pharmaceutical, biotech, and medical device companies in ensuring patient safety, regulatory compliance, and accurate reporting of clinical trial outcomes.
Role Overview
We are seeking a Pharmacovigilance Officer to join our team to support safety monitoring, case processing, and pharmacovigilance operations for ongoing clinical trials. This role involves end-to-end pharmacovigilance activities, including SAE/ICSR reporting, data management, regulatory submissions, and stakeholder communication, in line with global standards.
Key Responsibilities
Project Monitoring & Management:
Support departmental coordination using project management tools.
Prepare study safety documentation, including Serious Adverse Event (SAE) reporting forms and guidelines.
Develop training materials for investigator meetings and safety-related sessions.
Generate progress reports, listings, and study-related materials for Pharmacovigilance Safety Manager (PVSM) or clients.
Pharmacovigilance Operations:
Assist in SAE processing and reporting in compliance with SOPs, company policies, and regulatory guidelines (ICH, EMA, FDA).
Maintain and update the internal safety database.
Follow up on query resolution with Investigator Sites.
Develop case narratives ensuring accuracy, completeness, and high-quality documentation.
Distribute Individual Case Safety Reports (ICSRs) to Ethics Committees, Investigators, and Marketing Authorization Holders (MAHs).
Prepare 6-Monthly SUSAR Line Listings and DSUR narratives for submission to Competent Authorities and Ethics Committees.
Support MedDRA coding requests in coordination with Data Management and Statistics teams.
Participate in other pharmacovigilance activities as required.
Required Qualifications & Skills
Education: Any Graduate; Postgraduate degree preferred.
Experience: 2–3 years in pharmacovigilance, clinical research, or drug safety operations.
Strong knowledge of pharmacovigilance processes, SAE/ICSR reporting, and regulatory compliance.
Familiarity with safety databases and MedDRA coding.
Proficiency in Microsoft Office Suite and database management tools.
Understanding of ICH, EMA, and FDA guidelines for pharmacovigilance.
Strong organizational, communication, and analytical skills.
Ability to work in a remote or hybrid environment with cross-functional teams.
Why Join Veeda CR
Work with a global CRO committed to patient safety and clinical excellence.
Gain exposure to international pharmacovigilance standards and regulatory compliance.
Engage in career growth opportunities with mentorship and hands-on project experience.
Contribute to life-changing clinical trials and real-world patient safety outcomes.
SEO & GPT Optimized Keywords:
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