Drug Safety Associate I

TheClinixAI; Hyderabad; Hybrid; INR 300,000 - 520,000; Full time

Job summary

TheClinixAI in Hyderabad/Remote is seeking a Drug Safety Associate I to support pharmacovigilance operations such as case intake, triage, data entry and quality-focused processing. This execution-focused role suits candidates with PV fundamentals and a drive for production discipline.

Responsibilities include case processing, coding with MedDRA, and drafting narratives. A 1–2 year background in PV or related fields is preferred, with strong English communication and structured workflow

Qualifications

• Bachelor's or master's degree in Pharmacy, Life Sciences, Medicine, Nursing or related discipline.
• 1–2 years of pharmacovigilance, clinical research, drug safety or healthcare experience.
• Knowledge of ICSR concepts, seriousness, causality basics, MedDRA and PV terminology.
• Good written English and strong attention to detail.
• Ability to work with structured workflows, SOPs, timelines and quality targets.

Responsibilities

• Receive, triage and process individual case safety reports per SOPs and project requirements.
• Review source information for completeness, validity, seriousness, and reportability indicators.
• Enter and maintain accurate case data in safety databases and complete required workflows on time.
• Perform MedDRA coding and escalate uncertain coding decisions.
• Draft clear, medically coherent case narratives when required.
• Identify missing information and initiate follow-up activities.
• Perform case reconciliation and documentation activities.
• Respond to QC findings, correct errors and demonstrate quality improvements.
• Maintain confidentiality of patient, reporter, product and client information.

Skills

ICSR concepts

MedDRA

PV terminology

Attention to detail

Strong English writing

Education

Bachelor's or Master's in Pharmacy/Life Sciences/Medicine/Nursing

Tools

Argus

ArisGlobal

Veeva Vault Safety

Job description

Hyderabad / Remote · 1–2 years experience · Pharmacovigilance

About the role

We are looking for a detail-oriented Drug Safety Associate I to support pharmacovigilance operations across case intake, triage, data entry, follow-up and quality-focused case processing. This is an execution-focused role for candidates who understand PV fundamentals and want to build strong production discipline.

Key responsibilities

• Receive, triage and process individual case safety reports in accordance with applicable SOPs and project requirements.
• Review source information for completeness, validity, seriousness, expectedness and reportability indicators as assigned.
• Enter and maintain accurate case data in approved safety databases and complete required workflow activities within timelines.
• Perform MedDRA and product coding with appropriate conventions and escalate uncertain coding decisions.
• Draft clear, medically coherent case narratives where required by the workflow.
• Identify missing information and initiate or support appropriate follow-up activities.
• Perform case reconciliation and documentation activities as assigned.
• Respond to QC findings, correct errors and demonstrate sustained improvement in quality.
• Maintain confidentiality of patient, reporter, product and client information.
• Support literature, regulatory or other PV activities when assigned and trained.

Required qualifications

• Bachelor's or master's degree in Pharmacy, Life Sciences, Medicine, Nursing or a related discipline.
• 1–2 years of relevant pharmacovigilance, clinical research, drug safety or healthcare experience.
• Working knowledge of ICSR concepts, seriousness, causality basics, MedDRA and PV terminology.
• Good written English and strong attention to detail.
• Ability to work with structured workflows, SOPs, timelines and quality targets.

Preferred skills

• Exposure to Argus, ArisGlobal, Veeva Vault Safety or another safety database.
• Awareness of ICH, GVP and expedited reporting concepts.
• Excel proficiency and comfort working with structured data.

What success looks like

You consistently process assigned work accurately and on time, respond well to QC feedback, follow SOPs and escalate issues appropriately. You are able to take increasing ownership of routine PV activities with limited supervision.