Medical Reviewer - Lead

Golden Opportunities; Chennai; Remote; INR 1,100,000 - 1,900,000; Full time

Job summary

Golden Opportunities in India is seeking an experienced regulatory affairs professional to prepare and review comprehensive aggregate safety reports such as PBRER, PADER, and RMP. The role requires coordination with multiple stakeholders to collect data and respond to regulatory queries.

Candidates should have 7–10 years of relevant experience, MBBS qualification, and strong skills in PSUR, ICSR, signal detection, and medical review. This is a work-from-home opportunity with Pan India coverage.

Qualifications

• MBBS required with pharma-industry exposure preferred.
• Experience with regulatory safety reporting and signal detection.
• Experience in compiling PSUR/ICSR/Aggregate reports.

Responsibilities

• Prepare and review Aggregate reports (PBRER, PADER, RMP, ADCO).
• Coordinate with stakeholders to gather data for reports.
• Liaise with service providers and resolve queries.
• Coordinate internal and external stakeholders for reports completion.
• Prepare and review regulatory authority query responses.

Skills

PSUR

ICSR

Aggregate report

Safety Physician

Medical Review

Signal Detection

Education

MBBS

Job description

• Job Location: Pan India
• Work Model: Work from Home
• Candidate Expectations Total and Relevant Experience 7 Years to 10 Years
• Candidate Location - Anywhere Skills PSUR, ICSR, Aggregate report, Safety Physician, Medical Review, Signal Detection
• Candidate Industry (Pharma) Diversity No
• Education and Certification Qualification: MBBS
• Specific Remarks: Distance education not accepted.
• Certification: NA Detailed

Job Description

• Preparation and review of aggregate reports such as Periodic Benefit‑Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Risk Management Plans (RMPs), Addendum to Clinical Overview (ADCO) etc.
• Co‑ordination with various stakeholders to gather data required for Aggregate reports.
• Work closely with service providers and resolve their queries.
• Co‑ordinate with various stakeholders internal and external required for the completion reports.
• Preparation and review of Query responses from Regulatory Authority.

Key Skills

• PSUR, ICSR, Aggregate report, Safety Physician, Medical Review, Signal Detection

Other Specific Remarks Additional Requirements:

• Proper documents for entire career and PF Form 16 Mandatory