KlinEra Hiring Drug Safety Associate Jobs in Mumbai for experienced pharmacovigilance professionals with Veeva expertise. Apply online today.
Introduction
KlinEra is inviting applications for the position of Drug Safety Associate in Mumbai for experienced pharmacovigilance professionals. Candidates with 2 to 4 years of experience in drug safety operations and hands-on exposure to Veeva Vault Safety are encouraged to apply. This opportunity offers valuable exposure to global safety reporting, regulatory compliance, SAE management, and clinical trial pharmacovigilance activities. Professionals looking to advance their careers in Pharmacovigilance Jobs, Clinical Research Jobs, and Regulatory Affairs Jobs can explore this promising opening with a growing clinical research organization.
About Company
KlinEra is a globally recognized clinical research and healthcare solutions organization providing comprehensive services across clinical development, pharmacovigilance, regulatory affairs, medical writing, and healthcare consulting. The company partners with pharmaceutical, biotechnology, and medical device organizations to support drug development and regulatory compliance throughout the product lifecycle.
With a strong focus on quality, innovation, and patient safety, KlinEra delivers customized solutions for clinical trials, safety monitoring, risk management, and regulatory submissions. Its team of experienced professionals works across multiple therapeutic areas and global markets, ensuring compliance with international healthcare regulations. Through its expertise in clinical research and pharmacovigilance, KlinEra continues to strengthen its position as a trusted partner within the pharmaceutical and life sciences industry.
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Job Details / Job Summary
| Particulars | Details |
|---|---|
| Company Name | KlinEra |
| Job Role | Drug Safety Associate |
| Department | Pharmacovigilance / Drug Safety |
| Qualification Required | B.Pharm, M.Pharm, Pharm.D, M.Sc Life Sciences, Biotechnology, Clinical Research, or relevant Life Science disciplines |
| Experience Required | 2–4 Years |
| Salary Package | As per company standards and candidate experience |
| Job Location | Mumbai, Maharashtra |
| Employment Type | Full-Time |
| Industry Type | Clinical Research / Pharmaceutical / Pharmacovigilance |
| Shift Timing | General Shift |
| Gender Eligibility | Male & Female |
| Application Mode | Email Application |
| Selection Process | Resume Screening, Interview, Technical Assessment, HR Discussion |
| Skills Required | Pharmacovigilance, SAE Management, Veeva Vault Safety, Regulatory Reporting, CIOMS Submissions |
| Official Notification Status | Active |
| Application Last Date | Apply at the earliest |
Eligibility Criteria
Candidates applying for this Pharma Company Hiring opportunity should meet the following requirements:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Clinical Research, or related discipline.
- Minimum 2 years and maximum 4 years of relevant pharmacovigilance experience.
- At least 1 year of practical experience working with Veeva Vault Safety.
- Knowledge of Indian and international pharmacovigilance regulations.
- Experience in SAE processing and safety reporting activities.
- Strong documentation and communication skills.
- Ability to work within regulatory timelines and compliance requirements.
- Candidates available to join within one month will be preferred.
Required Skills
The ideal candidate should possess the following professional competencies:
- Pharmacovigilance operations management
- Serious Adverse Event (SAE) handling
- Safety database management
- Veeva Vault Safety expertise
- CIOMS report preparation and submission
- DSUR compilation and regulatory submissions
- CDSCO compliance knowledge
- Clinical trial safety reporting
- Regulatory documentation management
- Audit and inspection readiness
- Data reconciliation and safety tracking
- Cross-functional communication skills
- Problem-solving and analytical capabilities
Roles and Responsibilities
The Drug Safety Associate will perform the following responsibilities:
- Submit global and local CIOMS reports within regulatory timelines.
- Maintain DCGI CIOMS-I acknowledgements and documentation records.
- Coordinate site submissions of safety reports.
- Prepare and submit annual Development Safety Update Reports (DSURs).
- Track and maintain safety reporting activities for assigned projects.
- Review Serious Adverse Events and assess reporting requirements.
- Reconcile SAE listings and ensure data consistency.
- Manage safety-related queries from regulatory authorities.
- Monitor updates from Indian and international health authorities.
- Support safety compliance initiatives across clinical projects.
- Maintain safety submission trackers and reporting databases.
- Prepare safety presentations and project-related documentation.
- Follow company SOPs, work instructions, and pharmacovigilance guidelines.
- Contribute to SOP development and process improvement initiatives.
- Participate in client meetings and project discussions.
- Assist during regulatory inspections and sponsor audits.
- Mentor junior team members whenever required.
- Support additional drug safety and pharmacovigilance activities assigned by management.
Salary Details
The salary package for this position will depend on the candidate’s qualifications, relevant experience, technical expertise, and previous compensation. Professionals with strong experience in Veeva Vault Safety, SAE management, and regulatory reporting may receive competitive industry-standard remuneration along with performance-based benefits and career growth opportunities.
Expected Salary Range:
- ₹4.5 LPA – ₹8.5 LPA (Approximate industry range)
- Final compensation will be determined by KlinEra during the hiring process.
Selection Process
The recruitment process may include the following stages:
1. Application Screening
The recruitment team reviews submitted resumes and evaluates eligibility criteria.
2. Technical Evaluation
Shortlisted candidates may undergo an assessment focusing on pharmacovigilance operations, SAE management, and regulatory reporting knowledge.
3. Interview Round
Candidates attend technical and functional interviews with hiring managers and pharmacovigilance leaders.
4. HR Discussion
Selected candidates participate in salary negotiation and employment discussions.
5. Final Offer
Successful candidates receive an official employment offer and onboarding instructions.
How to Apply
Interested and eligible candidates can apply by sending their updated resume to the official recruitment email.
Email ID: prachi.sonawane@klinera.com
Applicants should mention the following details in their application:
- Total Years of Experience
- Current CTC
- Expected CTC
- Notice Period
- Experience in Veeva Vault Safety (Yes/No)
Candidates meeting the required qualifications and experience criteria are encouraged to apply as early as possible for consideration.
Frequently Asked Questions (FAQs)
1. What qualifications are required for the Drug Safety Associate position at KlinEra?
Candidates with B.Pharm, M.Pharm, Pharm.D, M.Sc Life Sciences, Biotechnology, Clinical Research, or related life science qualifications can apply.
2. Are freshers eligible for this Pharmacovigilance Job?
No. This position requires 2 to 4 years of relevant pharmacovigilance or drug safety experience. Freshers Pharma Jobs are not applicable for this role.
3. What is the expected salary for this position?
The expected salary may range between ₹4.5 LPA and ₹8.5 LPA depending on experience, skills, and interview performance.
4. How can I apply for this Latest Pharma Jobs opening?
Candidates can apply by emailing their updated resume to the recruitment team and providing experience, salary, notice period, and Veeva experience details.