Pharmacovigilance Associate / Drug Safety Associate

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