Drug Safety Coordinator

2 weeks ago

Kochi, India mercury connections Full time

**Job Overview**:
A Drug Safety Coordinator is responsible for coordinating and supporting activities related to the collection, assessment, and reporting of adverse events associated with pharmaceutical products. They work closely with cross-functional teams, regulatory authorities, and external partners to ensure compliance with pharmacovigilance regulations and guidelines.

**Key Responsibilities**:
1. Adverse Event Management:

- Receive and process adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials.
- Ensure timely and accurate documentation of adverse events in the safety database.

2. Case Assessment:

- Conduct initial assessments of adverse event reports to determine seriousness, expectedness, and causality.
- Collaborate with medical professionals and assessors to gather additional information for comprehensive case evaluations.

3. Reporting:

- Prepare and submit expedited and periodic safety reports to regulatory authorities in compliance with applicable regulations.
- Generate and distribute safety reports internally and externally as required.

4. Communication:

- Serve as a point of contact for internal and external stakeholders regarding drug safety queries.
- Communicate with healthcare professionals, investigators, and regulatory agencies as needed.

5. Compliance:

- Stay updated on pharmacovigilance regulations and guidelines to ensure compliance.
- Participate in the development and implementation of pharmacovigilance processes and procedures.

6. Training:

- Provide training and support to internal staff and external partners on drug safety reporting requirements and processes.

7. Quality Assurance:

- Participate in quality assurance activities related to pharmacovigilance, including internal audits and inspections.

**Qualifications**:

- Bachelor's or advanced degree in pharmacy, life sciences, nursing, or a related field.
- Knowledge of pharmacovigilance regulations, guidelines, and best practices.
- Familiarity with safety databases and adverse event reporting systems.

**Skills**:

- Strong attention to detail and accuracy in data entry and documentation.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively in cross-functional teams.
- Analytical and problem-solving skills.

**Experience**:

- Previous experience in drug safety, pharmacovigilance, or a related field.
- Familiarity with safety databases and adverse event reporting systems.
- Experience in preparing and submitting regulatory safety reports.

**Salary**: ₹450,000.00 - ₹480,000.00 per year

Schedule:

- Day shift

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- Kochi, Kerala (required)

Ability to Relocate:

- Kochi, Kerala: Relocate with an employer provided relocation package (required)

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