Drug Safety Officer
2 weeks ago
**Overview**:
**Responsibilities**:
- **Adverse Event Processing**:
Receive, evaluate, and process adverse event reports from various sources, ensuring accurate and timely documentation in compliance with regulatory requirements.
- **Case Management**:
Conduct thorough case investigations, including follow-up with healthcare professionals and patients to obtain additional information.
Document all findings in the safety database.
- **Regulatory Compliance**:
Stay informed about current pharmacovigilance regulations and guidelines.
Ensure all adverse event reports are handled in compliance with local and international regulatory requirements.
- **Safety Surveillance**:
Monitor safety signals, trends, and patterns in adverse event data.
Collaborate with cross-functional teams to assess and communicate potential safety concerns.
- **Quality Assurance**:
Participate in internal and external audits related to pharmacovigilance activities.
Implement corrective and preventive actions as necessary.
- **Signal Detection**:
Contribute to signal detection activities, including the review of relevant literature and participation in safety review meetings.
**Qualifications**:
- Bachelor's degree in Pharmacy, Life Sciences, Nursing, or related field.
- Strong understanding of pharmacovigilance regulations and guidelines.
- Excellent communication and interpersonal skills.
- Detail-oriented with the ability to manage multiple tasks efficiently.
- Proficient in using safety databases and other relevant software.
**Benefits**:
- Competitive salary and performance-based bonuses.
- Career development opportunities and training programs.
**Job Types**: Full-time, Permanent, Fresher
**Salary**: ₹9,967.44 - ₹45,345.73 per month
**Benefits**:
- Health insurance
- Paid sick time
- Paid time off
Schedule:
- Day shift
- Weekend availability
Supplemental pay types:
- Performance bonus
- Quarterly bonus
**Education**:
- Bachelor's (preferred)
Work Location: In person
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