Pharmacovigilance Associate

5 days ago

Ameerpet Hyderabad Telangana, India FORWARD LIFE PVT.LTD Full time

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

**Employment Type**: Full-time

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

**Benefits**:

- Health insurance
- Provident Fund

Work Location: In person

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