Medreich Limited Pharmacovigilance Jobs – Bengaluru

Medreich Limited Pharmacovigilance Jobs – Bengaluru

Medreich Limited is hiring Pharmacovigilance professionals in Bengaluru for a specialized role in Aggregate Reporting and Core Submissions. The position involves end-to-end authoring, scientific evaluation, and timely submission of global periodic safety reports and core regulatory submissions. The role also serves as a Subject Matter Expert (SME) for cumulative safety data analysis, signal detection, and preparation of key regulatory documents. Candidates with 4–5 years of experience and an M.Pharm/Pharm.D background are preferred.

Pharmacovigilance Aggregate Reporting and Core Submissions Specialist

Job Role & Responsibilities

The Pharmacovigilance Aggregate Reporting and Core Submissions Specialist will be responsible for:

• End-to-end authoring of global periodic safety reports.
• Scientific evaluation of cumulative safety data.
• Timely submission of periodic safety reports and core submissions.
• Analysing cumulative safety data.
• Detecting and evaluating safety signals.
• Compiling key regulatory files.
• Ensuring compliance with global Health Authority requirements.

Key Regulatory Documents

The role involves preparation and compilation of:

• Periodic Safety Update Reports (PSURs)
• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Risk Management Plans (RMPs)
• Addendums to Clinical Overviews

Eligibility & Qualifications

Experience

• 4–5 years of relevant experience in Pharmacovigilance is preferred.

Educational Qualification

• M.Pharm / Pharm background preferred.

Eligible Qualification Courses

M.Pharm | Pharm.D | Pharmacy-related qualifications

How to Apply

Interested candidates can connect with the recruitment contacts below:

Email: varsha.h@medreich.com
Email: swathi.ds@medreich.com

Candidates with relevant Pharmacovigilance, aggregate reporting, safety evaluation, signal detection, and regulatory submissions experience may apply.

Job Summary