This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Drug Safety Associate based in India.
This role offers an opportunity to contribute to global pharmacovigilance and clinical research initiatives within a collaborative and science-driven environment.
The Senior Drug Safety Associate will manage complex safety operations, ensuring high-quality case processing, regulatory compliance, and accurate safety documentation.
The position requires strong expertise in pharmacovigilance processes, safety databases, and regulatory guidelines while supporting internal teams and external stakeholders.
You will act as a subject matter expert, providing strategic input, mentoring colleagues, and driving continuous improvements across safety workflows.
This role combines technical expertise, client collaboration, and project ownership to help deliver reliable safety outcomes for pharmaceutical and healthcare programs.
The ideal candidate is detail-oriented, proactive, and passionate about advancing patient safety through high-quality clinical data management.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Drug Safety Associate based in India.
This role offers an opportunity to contribute to global pharmacovigilance and clinical research initiatives within a collaborative and science-driven environment.
The Senior Drug Safety Associate will manage complex safety operations, ensuring high-quality case processing, regulatory compliance, and accurate safety documentation.
The position requires strong expertise in pharmacovigilance processes, safety databases, and regulatory guidelines while supporting internal teams and external stakeholders.
You will act as a subject matter expert, providing strategic input, mentoring colleagues, and driving continuous improvements across safety workflows.
This role combines technical expertise, client collaboration, and project ownership to help deliver reliable safety outcomes for pharmaceutical and healthcare programs.
The ideal candidate is detail-oriented, proactive, and passionate about advancing patient safety through high-quality clinical data management.
Accountabilities
- Independently manage end-to-end drug safety case processing activities, ensuring accuracy, completeness, and compliance with applicable regulations and procedures.
- Apply strong knowledge of pharmacovigilance regulations, clinical trial processes, and safety reporting requirements to daily operations.
- Lead the development and maintenance of high-quality safety deliverables, including narratives and safety documentation.
- Serve as a subject matter expert by providing guidance, mentoring team members, and supporting knowledge sharing initiatives.
- Manage client interactions, including meetings, feedback discussions, and issue resolution to maintain strong partnerships.
- Lead projects from initiation through completion while identifying opportunities to improve efficiency and optimize departmental processes.
- Perform quality control reviews and ensure compliance with internal procedures, client requirements, and regulatory standards.
- Apply expert knowledge of MedDRA and WHO Drug Dictionary coding principles to support accurate safety data management.
- Monitor the impact of updates and changes across related safety deliverables and processes.
- Support regulatory and quality initiatives, including compliance with standards such as ISO 9001, ISO 27001, FDA requirements, and GCP guidelines.
- Bachelor’s degree in a scientific, medical, clinical, or related discipline; advanced degrees such as a Master’s or PhD are preferred.
- Minimum of 5 years of experience in drug safety, pharmacovigilance, clinical research, or a related field.
- Strong understanding of scientific principles, clinical trial processes, pharmaceutical development, and safety data terminology.
- Extensive experience with safety databases, case processing workflows, and pharmacovigilance documentation.
- Expert knowledge of MedDRA and WHO Drug Dictionary coding.
- Familiarity with regulatory requirements including FDA regulations, 21 CFR Part 11, GCP, and applicable safety guidelines.
- Experience working with CRO environments and pharmaceutical or biotechnology projects is preferred.
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
- Excellent written and verbal communication skills, with the ability to collaborate with clients and internal teams.
- Proficiency with Microsoft Office applications and safety writing tools.
- Strong analytical thinking, problem-solving abilities, and a commitment to quality.
- Remote work opportunity with flexible collaboration in a global clinical research environment.
- Opportunity to contribute to innovative pharmaceutical, biotechnology, and medical device programs.
- Exposure to international safety operations and complex pharmacovigilance projects.
- Career growth opportunities through mentorship, knowledge sharing, and professional development.
- Supportive and collaborative team culture focused on scientific excellence and continuous improvement.
- Opportunity to work with experienced professionals across global clinical research functions.
The Senior Drug Safety Associate will oversee key pharmacovigilance activities, ensuring compliance with industry regulations and delivering accurate safety outputs. The role involves managing safety cases, supporting client relationships, improving processes, and acting as a trusted resource for internal and external teams.
Requirements
The ideal candidate is an experienced pharmacovigilance professional with strong scientific knowledge, regulatory understanding, and the ability to manage complex safety activities independently. This position requires excellent communication skills, attention to detail, and the ability to collaborate effectively with diverse stakeholders.