Drug Safety Officer

4 days ago

Vadodara Gujarat, India Confident Full time

**Job Summary**:
The Drug Safety Officer is responsible for monitoring, assessing, and ensuring the safety of pharmaceutical products throughout their lifecycle. This role involves the collection and analysis of adverse event data, preparation of safety reports, and collaboration with regulatory authorities to maintain compliance with global pharmacovigilance regulations.

**Key Responsibilities**:

- **Adverse Event Reporting**:

- Collect, evaluate, and process Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources.
- Ensure timely and accurate data entry into safety databases in accordance with company Standard Operating Procedures (SOPs) and regulatory
- **Safety Data Analysis**:

- Analyze clinical trial and post-marketing data to identify potential safety signals.
- Conduct risk assessments and recommend mitigation strategies as
- **Regulatory Compliance**:

- Prepare and submit safety reports to regulatory authorities, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
- Stay updated on global pharmacovigilance regulations and ensure company
- **Cross-Functional Collaboration**:

- Work closely with clinical research, regulatory affairs, and medical affairs teams to provide safety input on study protocols and product information.
- Participate in safety review meetings and provide expert advice on safety-related matters.
- **Training and Development**:

- Provide training to internal staff on pharmacovigilance processes and regulatory requirements.
- Mentor junior team members and support their professional

**Qualifications**:

- **Education**:

- Bachelor’s degree in Pharmacy, Life Sciences, Medicine, or a related field.
- Advanced degrees (e.g., Master’s, PharmD) or certifications in pharmacovigilance
- **Experience**:

- Minimum of 2-5 years of experience in drug safety or pharmacovigilance roles.
- Familiarity with global regulatory requirements and pharmacovigilance
- **Skills**:

- Proficient in safety database systems and Microsoft Office Suite.
- Strong analytical and problem-solving abilities.
- Excellent written and verbal communication skills.

**Preferred Qualifications**:

- Experience with MedDRA and WHO Drug Dictionary coding.
- Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP).
- Ability to work effectively in a cross-functional team environment.

**Job Types**: Full-time, Permanent, Contractual / Temporary

Pay: ₹185,119.40 - ₹626,380.57 per year

**Benefits**:

- Health insurance

Schedule:

- Day shift

Work Location: In person

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