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Safety Associate

Marlabs
Marlabs
1-6 years
Not Disclosed
10 Jan. 1, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety Associate – Pharmacovigilance / Drug Safety

Company: Marlabs
Locations: Bengaluru, Kochi, Thane, Kolkata, India
Experience: 1 – 6 years
Employment Type: Full-Time, Permanent
Department: Pharmacovigilance / Safety
Industry: IT Services & Consulting / Life Sciences


About Marlabs

Marlabs is a global digital solutions company focused on leveraging data and technology to empower businesses. Our expertise spans AI & analytics, digital product engineering, advisory services, and agile engineering, enabling clients to transform data into actionable insights. With offices in the US, Germany, Canada, Brazil, and India, Marlabs employs 2,500+ technology and industry specialists dedicated to driving innovation.

Learn more: https://www.marlabs.com


Role Overview

As a Safety Associate, you will be responsible for ICSR (Individual Case Safety Report) processing, pharmacovigilance activities, and regulatory submissions. You will ensure compliance with project-specific SOPs, timelines, and global regulatory standards. This role may also involve mentoring junior team members and contributing to process improvements.


Key Responsibilities

  • Perform ICSR safety case processing into safety databases and prepare regulatory submission documents.

  • Prioritize and complete assigned trainings on time.

  • Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.

  • Conduct pharmacovigilance activities including:

    • Collecting and tracking Adverse Events (AEs) and endpoint information.

    • Determining initial/update status of incoming events.

    • Database entry and coding of AEs and products.

    • Writing case narratives.

    • Literature screening and review as per project timelines.

  • Ensure quality, productivity, and delivery standards are met per project requirements.

  • Ensure compliance to all project-related processes and activities.

  • Track and maintain cases according to project plans.

  • Identify and escalate quality problems to senior team members.

  • Mentor new team members if assigned by the Manager.

  • Participate in project team meetings and provide operational feedback.

  • Perform other duties as assigned per project requirements.


Qualifications & Skills

  • Education: Minimum Life Science Graduation (Biotechnology) or Healthcare Professionals (B.Pharm, M.Pharm, Pharm.D) preferred.

  • Experience: 1 – 6 years in pharmacovigilance / drug safety roles.

  • Technical Skills:

    • ICSR Case Processing

    • Argus or similar Safety Databases

    • Pharmacovigilance procedures and regulatory compliance

  • Soft Skills:

    • Strong organizational and time management skills

    • Attention to detail and quality-focused mindset

    • Good communication and teamwork abilities


Locations

  • Bengaluru, Karnataka

  • Kochi, Kerala

  • Thane, Maharashtra

  • Kolkata, West Bengal