Website:
synapmed.com
Job details:
About the Role:
(Please note: Candidates with strictly ICSR/Case Processing experience background will not be shortlisted).
Synapmed is actively seeking a highly skilled Medical Reviewer - Manager of Drug Safety & Pharmacovigilance to join our growing team in Hyderabad. In this critical role, you will take ownership of end-to-end medical review, aggregate reporting, and signal management activities for our global markets. You will operate in a hybrid work model, collaborating with cross-functional teams to ensure global regulatory compliance and patient safety.
Key Responsibilities:
Independently author, review, and finalize Aggregate Safety Reports including PSURs and PBRERs in compliance with US FDA, EMA, and ICH guidelines.
Perform routine and ad-hoc signal detection, signal validation, and author Signal Evaluation Reports.
Provide expert medical review and safety assessments for complex cases.
Extract, analyze, and interpret complex safety data from global safety databases (e.g., Oracle Argus, ArisG, Veeva).
Provide strategic medical safety input and ensure the quality and timeliness of all regulatory submissions.
Mentor and guide team members on global pharmacovigilance regulations and best practices in safety writing.
Mandatory Requirements:
Education (Strict Requirement): MBBS or MD is mandatory.
(Profiles without these specific medical degrees will not be evaluated for this role).
Experience:
5 to 8 years of dedicated experience in Pharmacovigilance.
Technical Skills:
Must possess hands-on experience authoring PSURs/PBRERs and managing signals.
Regulatory Knowledge:
Deep understanding of US, EU, and ICH pharmacovigilance regulations.
Work Setup:
Willingness to work in a Hybrid model from our Hyderabad office.
Compensation & Benefits:
Budget: Up to ₹25,00,000 LPA (Based on experience, current compensation, and technical interview performance).
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