Job Description

Job Title: Pharmacovigilance Associate / Drug Safety Associate

Location:

Ameerpet

Department:

Pharmacovigilance / Drug Safety

Reports To:

PV Manager / Head of Pharmacovigilance

Job Purpose:

To ensure patient safety by monitoring, collecting, assessing, and reporting adverse drug reactions (ADRs) and other safety information in compliance with global pharmacovigilance regulations and company policies.

Key Responsibilities:

*Collect, process, and review individual case safety reports (ICSRs) from healthcare professionals, patients, and literature.
*Perform data entry and medical coding of adverse events using safety databases (e.g., Argus/ARISg).
*Conduct case evaluation, narrative writing, and quality review of ADR reports.
*Support aggregate report preparation (PBRERs, PSURs, DSURs) as required.
*Assist in signal detection, risk assessment, and benefit-risk evaluation.
*Ensure compliance with global PV regulations (ICH, EMA, FDA, CDSCO).
*Liaise with cross-functional teams including clinical, regulatory, and quality departments.
*Participate in audits, inspections, and CAPA implementation.
*Maintain up-to-date knowledge of drug safety regulations and guidelines.

Required Qualifications:

Note: Only Males

Education:

Pharm D (Doctor of Pharmacy) - mandatory.
Knowledge of pharmacology, drug safety, and clinical practices.
Understanding of pharmacovigilance guidelines (ICH E2A-E2E, GVP modules).
Strong written and verbal communication skills.
Proficiency in MS Office and safety databases preferred.

Key Skills & Competencies:

Attention to detail and accuracy.
Analytical and critical thinking.
Ability to work under deadlines.
Team player with strong interpersonal skills.
Willingness to learn and adapt to regulatory changes.

Experience:

Fresher Pharm D candidates can apply (training will be provided).

Prior internship/experience in pharmacovigilance, clinical research, or regulatory affairs will be an added advantage.

Employment Type:

Full-time

Job Type: Full-time

Pay: ₹17,000.00 - ₹22,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person