Pharmacovigilance

2 weeks ago

Ahmedabad, India Pharmazone Full time

**Designation - Signal Detection and Management**
- 1. Assist the Signal Management Lead to develop the new signal detection process and changes to the signal tracking tool.
- 2. Assess currently utilized quality documents and develop/modify business processes as needed.
- 3. Develop training materials and provide training.
- 4. Develop and implement a consistent process to produce KPIs
- 5. Work closely with PM to ensure that timelines are met.
- 6. Coordinate and lead SMC meetings**Experience**:

- 1. Experienced in signal detection tools and processes
- 2. Skilled in implementing new business processes and technology solutions for signal detection in clinical development
- 3. Experienced in LEAN methodology
- 4. Working knowledge of regulations related to signal detection (GVP Module IX).
- 5. Proven expertise working with FAERS and WHO-Vigibase data
- 6. Ability to review complex information to develop business related strategies for integration of clinical development data and real-world data in the signaling process
- 7. At least 2-3 years of pharmacovigilance experience, especially in signal detection and management.
- 8. Strong consulting experience
- 9. Excellent Excel/WP/PowerPoint and technical writing skills
- 10. Clinical experience a plus**Experience**:
2-3 YEARS

**Qualification**:
M. Pharm / B. Pharm

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