Senior Drug Safety Associate
New
IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- Minimum of 5 years of experience in drug safety, pharmacovigilance, clinical research, or a related field.
- Required Skills
- GCP
Requirements
- Bachelor’s degree in a scientific, medical, clinical, or related discipline; advanced degrees 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.
- Proficiency with Microsoft Office applications and safety writing tools.
- Strong analytical thinking, problem-solving abilities, and a commitment to quality.
Responsibilities
- 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.
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