Drug Safety Associate

🚀 WE’RE HIRING | Drug Safety Associate | KlinEra | Mumbai 🚀

Looking for a Drug Safety Associate job in Mumbai? KlinEra is hiring experienced Pharmacovigilance professionals for its Drug Safety team.

This opportunity is ideal for candidates with 2–4 years of Pharmacovigilance experience and at least 1 year of hands-on experience with Veeva who are looking to advance their careers in drug safety, SAE management, regulatory submissions, CIOMS reporting, and global safety compliance.

🏢 Company: KlinEra
🌐 Industry: Pharmacovigilance / Drug Safety / Clinical Research
👉 Role: Drug Safety Associate
💼 Experience: 2–4 Years
📍 Location: Mumbai, Maharashtra
🏢 Work Mode: Work From Office
🕒 Employment Type: Full-Time
⚡ Joining Timeline: Within 1 Month

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🔧 Key Responsibilities
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✔ Regulatory submission of Global and Local CIOMS reports within applicable timelines
✔ Maintain DCGI CIOMS-I acknowledgements
✔ Perform site submission of Global and Local CIOMS reports
✔ Submit Annual DSUR reports to regulatory authorities
✔ Maintain CIOMS tracking for assigned projects
✔ Perform maintenance and reconciliation of SAE listings
✔ Review Serious Adverse Events (SAEs) and ensure regulatory compliance
✔ Resolve and track SAE queries with CDSCO and regulatory authorities
✔ Monitor updates from Indian and global regulatory agencies
✔ Track safety submissions and compliance activities
✔ Prepare and deliver safety-related presentations
✔ Follow KlinEra SOPs, Work Instructions, and Pharmacovigilance guidelines
✔ Support development and revision of SOPs and Work Instructions
✔ Ensure compliant safety reporting as per global regulations
✔ Train and mentor junior safety professionals when required
✔ Participate in project meetings and client discussions
✔ Support client inspections and regulatory audits
✔ Perform additional pharmacovigilance activities assigned by management

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🎓 Required Qualifications
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Candidates with the following educational qualifications are eligible to apply:
✔ B.Pharm
✔ M.Pharm
✔ Pharm.D
✔ M.Sc Life Sciences
✔ Biotechnology
✔ Clinical Research
✔ Other relevant Life Science disciplines

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💼 Experience Requirements
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✔ 2–4 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

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🛠 Preferred Skills
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✅ Pharmacovigilance Operations
✅ SAE Management
✅ Regulatory Submissions
✅ CIOMS Reporting
✅ DSUR Preparation
✅ CDSCO Regulations
✅ Safety Database Management
✅ Veeva Vault Safety
✅ Audit Readiness
✅ Clinical Trial Safety Reporting
✅ Regulatory Compliance
✅ Drug Safety Documentation

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🎯 What We’re Looking For
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✔ Strong understanding of pharmacovigilance regulations
✔ Experience handling safety reporting activities
✔ Knowledge of Indian and global regulatory requirements
✔ Excellent documentation and tracking skills
✔ Strong analytical and problem-solving abilities
✔ Ability to work in a fast-paced project environment
✔ Effective communication and stakeholder management skills
✔ Attention to detail and compliance-focused mindset

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🌟 Why Join KlinEra?
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✨ Opportunity to work on global pharmacovigilance projects
✨ Exposure to regulatory reporting and safety compliance activities
✨ Hands-on experience with international regulatory requirements
✨ Collaborative clinical research environment
✨ Professional growth in Drug Safety and Pharmacovigilance
✨ Exposure to client interactions and regulatory inspections
✨ Career advancement opportunities within safety operations

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📩 Apply Now
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📧 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)

🔁 Referrals are highly appreciated!

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⚡ If you have experience in Pharmacovigilance, Drug Safety Operations, SAE Management, and Regulatory Reporting, KlinEra offers an excellent opportunity to accelerate your career in global drug safety and compliance.