Medreich Limited is hiring Pharmacovigilance professionals in Bengaluru for the position of Pharmacovigilance Aggregate Reporting and Core Submissions Specialist. The role focuses on authoring, scientific evaluation, and timely submission of global periodic safety reports and core submissions.
Job Details
| Job Details | Information |
|---|---|
| Company | Medreich Limited |
| Position | Pharmacovigilance Aggregate Reporting and Core Submissions Specialist |
| Location | Bengaluru |
| Experience | 4–5 years |
| Qualification | M.Pharm / Pharm |
| Domain | Pharmacovigilance |
Position
Pharmacovigilance Aggregate Reporting and Core Submissions Specialist
The position is responsible for the end-to-end authoring, scientific evaluation, and timely submission of global periodic safety reports and core submissions. The role also acts as a primary Subject Matter Expert (SME) in cumulative safety data analysis, signal detection, and preparation of key regulatory files.
Responsibilities
- Author and scientifically evaluate global periodic safety reports and core submissions.
- Ensure timely submission of periodic safety reports.
- Analyse cumulative safety data.
- Detect safety signals.
- Compile Periodic Safety Update Reports (PSURs).
- Compile Periodic Benefit-Risk Evaluation Reports (PBRERs).
- Compile Risk Management Plans (RMPs).
- Prepare Addendums to Clinical Overviews.
- Ensure compliance with global Health Authority requirements.
- Act as a primary Subject Matter Expert (SME) for the assigned activities.
Eligibility and Qualifications
- M.Pharm / Pharm background.
- 4–5 years of experience in Pharmacovigilance.
Required Skills
Candidates should have experience relevant to:
- Pharmacovigilance aggregate reporting
- PSUR/PBRER preparation
- Risk Management Plans (RMPs)
- Cumulative safety data analysis
- Signal detection
- Scientific evaluation
- Regulatory submissions
- Addendums to Clinical Overviews
- Global Health Authority requirements
Application Details
Interested candidates can connect with:
- Varsha: varsha.h@medreich.com
- Swathi: swathi.ds@medreich.com