Looking for a Drug Safety Associate job in Mumbai? KlinEra is hiring experienced pharmacovigilance professionals for its Drug Safety team. Candidates with 2-4 years of pharmacovigilance experience and at least 1 year of Veeva experience are encouraged to apply.
This opportunity is ideal for professionals seeking to advance their careers in drug safety, pharmacovigilance, regulatory submissions, SAE management, and safety reporting within the clinical research and pharmaceutical industry.
Job Overview
| Details | Information |
|---|---|
| Position | Drug Safety Associate |
| Company | KlinEra |
| Location | Mumbai, Maharashtra |
| Experience | 2-4 Years |
| Required Skill | Veeva (Minimum 1 Year Experience) |
| Joining Timeline | Within 1 Month |
| Industry | Pharmacovigilance / Drug Safety |
| Employment Type | Full-Time |
Key Responsibilities
The selected candidate will be responsible for:
- Regulatory submission of Global and Local CIOMS reports within applicable timelines.
- Maintenance of DCGI CIOMS-I acknowledgements.
- Site submission of Global and Local CIOMS reports.
- Submission of Annual DSUR reports to regulatory authorities.
- Maintaining CIOMS tracking for all assigned projects.
- Maintenance and reconciliation of SAE listings.
- Reviewing Serious Adverse Events (SAEs) and ensuring regulatory compliance.
- SAE query resolution and tracking with CDSCO and relevant authorities.
- Monitoring and implementing updates from Indian and global drug regulatory agencies.
- Tracking safety submissions and compliance activities.
- Preparing and delivering safety-related presentations.
- Following KlinEra SOPs, Work Instructions, and Pharmacovigilance guidelines.
- Supporting development and updates of departmental SOPs and Work Instructions.
- Ensuring compliant safety reporting according to Indian and international pharmacovigilance regulations.
- Training and mentoring junior safety professionals when required.
- Participating in project team meetings and client discussions.
- Supporting client inspections and regulatory audits.
- Performing additional pharmacovigilance and drug safety activities assigned by management.
Required Qualifications
Candidates should possess:
Educational Qualification
- B.Pharm
- M.Pharm
- Pharm.D
- M.Sc Life Sciences
- Biotechnology
- Clinical Research
- Other relevant Life Science disciplines
Experience Requirements
- 2 to 4 years of Pharmacovigilance or Drug Safety experience.
- Minimum 1 year of hands-on experience with Veeva.
- Experience in SAE processing, safety reporting, CIOMS submissions, or regulatory compliance preferred.
Preferred Skills
- Pharmacovigilance operations
- SAE management
- Regulatory submissions
- CIOMS reporting
- DSUR preparation
- CDSCO regulations
- Safety database management
- Veeva Vault Safety
- Audit readiness
- Clinical trial safety reporting
Why Join KlinEra?
- Opportunity to work on global pharmacovigilance projects.
- Exposure to regulatory reporting and safety compliance activities.
- Collaborative clinical research environment.
- Professional growth in drug safety and pharmacovigilance.
- Hands-on experience with international regulatory requirements.
How to Apply
Interested candidates can send their updated resume to:
Email: prachi.sonawane@klinera.com
Please include the following details in your application:
- Notice Period
- Current Salary
- Expected Salary
- Total Years of Experience
- Veeva Experience (Yes/No)
Early applicants meeting the eligibility criteria will be given preference.