MidVik Solutions is hiring experienced Pharmacovigilance professionals for a Clinical Trial Submissions SME position in Jubilee Hills, Hyderabad. The opportunity is suitable for candidates with hands-on experience in clinical trial safety submissions, SUSAR, DSUR, ICSR, expedited reporting, Health Authority submissions and Ethics Committee submissions.
The role is particularly relevant for PV professionals looking to strengthen their experience in clinical trial safety and regulatory compliance. MidVik Solutions has also advertised other clinical and pharmacovigilance roles in Hyderabad, including physician pharmacovigilance positions.
Job Overview
| Details | Information |
|---|---|
| Company | MidVik Solutions |
| Job Role | PV Clinical Trial Submissions SME |
| Experience | 2–6 years |
| Location | Jubilee Hills, Hyderabad |
| Work Mode | Work From Office |
| Employment Type | Full-time |
| Industry | Pharmacovigilance / Clinical Research |
| Salary | Not disclosed by the employer |
Key Responsibilities
The selected candidate will be expected to contribute to clinical trial safety submission activities, including:
- Manage and support clinical trial safety submissions.
- Prepare and coordinate SUSAR submissions.
- Support preparation and submission of DSURs (Development Safety Update Reports).
- Handle ICSR and expedited safety reporting activities.
- Coordinate submissions to relevant Health Authorities.
- Support Ethics Committee submissions and associated documentation.
- Ensure submissions are completed accurately and within applicable timelines.
- Maintain compliance with applicable pharmacovigilance regulations and SOPs.
- Review submission-related documentation for completeness and accuracy.
- Coordinate with internal PV, clinical, regulatory and safety stakeholders.
- Identify submission-related issues and support timely resolution.
- Maintain appropriate records and documentation for audit and inspection readiness.
Required Skills
Candidates should have practical experience in:
- Clinical Trial Safety Submissions
- Pharmacovigilance
- SUSAR
- DSUR
- ICSR
- Expedited Reporting
- Health Authority Submissions
- Ethics Committee Submissions
- PV Regulations
- Pharmacovigilance Compliance
- Clinical Trial Safety
- Drug Safety Operations
Who Can Apply?
This opportunity is best suited for Pharmacovigilance professionals with 2–6 years of relevant experience, particularly candidates who have worked directly on clinical trial safety submissions.
Candidates with experience in SUSAR reporting, DSUR preparation, ICSR processing, expedited reporting and regulatory/ethics committee submissions should consider applying.
Relevant educational backgrounds may include Pharm.D, M.Pharm, B.Pharm, MSc Life Sciences, Clinical Research or other relevant life-science qualifications, subject to the employer’s specific hiring requirements.
Why Consider This Opportunity?
A Clinical Trial Safety Submissions role can provide valuable exposure to several critical areas of drug safety, including:
- Clinical trial pharmacovigilance
- Regulatory safety reporting
- SUSAR management
- DSUR activities
- ICSR and expedited reporting
- Health Authority interactions
- Ethics Committee submissions
- PV compliance and quality processes
For professionals building a career in clinical research, pharmacovigilance and drug safety, this type of role can offer cross-functional exposure across clinical safety and regulatory processes.
Location & Work Environment
The position is based in Jubilee Hills, Hyderabad, and is listed as a Work From Office opportunity. Candidates should therefore be prepared to work from the Hyderabad office.
How to Apply
Interested candidates can apply by sending their updated CV directly to:
Email: raju@midvik.com