Drug Safety Associate II

TheClinixAI; Hyderabad; Hybrid; INR 600,000 - 900,000; Full time

Job summary

TheClinixAI in Hyderabad is seeking a Drug Safety Associate II to independently process safety cases, ensure data quality and timely completion of workflows. You will handle intake, triage, coding (MedDRA) and narrative writing, while supporting junior staff and contributing to process improvements.

With 2–4 years in pharmacovigilance and a Pharmacy/Life Sciences degree, you’ll thrive in a remote-friendly hybrid setup that values documentation excellence and timely regulatory adherence.

Qualifications

• Bachelor's or master's degree in Pharmacy, Life Sciences, Medicine, Nursing or related discipline.
• 2–4 years of hands-on pharmacovigilance or drug safety experience.
• Strong working knowledge of ICSR processing, MedDRA coding, seriousness, causality concepts and follow-up.

Responsibilities

• Independently process serious and non-serious ICSRs according to SOPs, project conventions and regulatory timelines.
• Perform case intake, triage, duplicate assessment, data entry, coding, narrative writing, assessment and workflow completion.
• Review source documents for clinical completeness and identify discrepancies requiring clarification.
• Perform MedDRA and product coding and apply project-specific conventions consistently.
• Support follow-up case processing, reconciliation, nullification, downgrade/upgrade and other lifecycle activities as applicable.
• Conduct peer review or secondary checks when assigned and provide actionable feedback.
• Monitor assigned workload and escalate timeline or quality risks early.
• Support literature and regulatory reporting workflows where trained.
• Contribute to SOP, work-instruction and process improvement discussions.
• Coach junior associates on routine case-processing questions and good documentation practices.

Skills

Written communication

Documentation

Analytical skills

PV workflow understanding

Education

Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, Nursing or related discipline

Tools

Argus

ArisGlobal

Veeva Vault Safety

Job description

Hyderabad / Remote · 2–4 years experience · Pharmacovigilance

About the role

The Drug Safety Associate II is an experienced case-processing professional responsible for independent handling of assigned safety cases, quality of case data, timely completion of workflows and appropriate escalation. The role also supports junior team members and contributes to process consistency.

Key responsibilities

• Independently process serious and non-serious ICSRs according to SOPs, project conventions and regulatory timelines.
• Perform case intake, triage, duplicate assessment, data entry, coding, narrative writing, assessment and workflow completion.
• Review source documents for clinical completeness and identify discrepancies requiring clarification.
• Perform MedDRA and product coding and apply project-specific conventions consistently.
• Support follow-up case processing, reconciliation, nullification, downgrade/upgrade and other lifecycle activities as applicable.
• Conduct peer review or secondary checks when assigned and provide actionable feedback.
• Monitor assigned workload and escalate timeline or quality risks early.
• Support literature and regulatory reporting workflows where trained.
• Contribute to SOP, work-instruction and process improvement discussions.
• Coach junior associates on routine case-processing questions and good documentation practices.

Required qualifications

• Bachelor's or master's degree in Pharmacy, Life Sciences, Medicine, Nursing or related discipline.
• 2–4 years of hands-on pharmacovigilance or drug safety experience.
• Strong working knowledge of ICSR processing, MedDRA coding, seriousness, causality concepts and follow-up.
• Experience working within safety databases and controlled PV workflows.
• Strong written communication, documentation and analytical skills.

Preferred skills

• Experience with Argus, ArisGlobal, Veeva Vault Safety or equivalent.
• Exposure to ICH E2A/E2B, GVP and expedited reporting requirements.
• Experience supporting QC, metrics, reconciliation or audit readiness.

What success looks like

You independently deliver assigned cases with consistent quality and timeline adherence, identify risks before they become issues and contribute positively to team quality and productivity.