Drug Safety Associate
Proxima Skills Academy
Bengaluru, Karnataka, IndiaFresher2h agovia LinkedIn
About the Role
The Drug Safety Associate (Freshers) will support pharmacovigilance activities by collecting, reviewing, and documenting safety data related to pharmaceutical products. This is a full-time, hybrid role based in Bengaluru.
Key Responsibilities
- Case processing
- Drafting and updating safety narratives
- Ensuring data accuracy
- Assisting in the preparation of regulatory safety reports under supervision
- Coordinating with internal teams to adhere to standard operating procedures, quality standards, and timelines
- Maintaining compliance with global drug safety and regulatory guidelines
Requirements & Tech Stack
- MS Office tools proficiency
- Familiarity or willingness to learn medical coding standards (e.g., MedDRA, WHO-DD)
Qualifications
- Strong narrative and documentation skills to prepare clear, concise safety case summaries and reports
- Quality control skills to verify data accuracy, completeness, and consistency in drug safety documentation
- Foundational knowledge of regulatory affairs, including basic understanding of pharmacovigilance regulations and compliance requirements
- Academic knowledge in pharmacy or related life sciences fields, with an interest in drug safety and clinical research
- Strong attention to detail
- Analytical thinking
- Good written and verbal communication skills
- Ability to follow SOPs
- Willingness to learn in a structured training environment
- Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Nursing, or related discipline
- Any training or certification in pharmacovigilance or drug safety is an advantage.