
Pharmacovigilance Associate
1 week ago
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, ₹22,000.00 per month
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
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