Medical Device Safety Vigilance Specialist – Hyderabad | On-site
Job Summary:
Amgen is seeking a seasoned Medical Device Safety Vigilance Specialist for its Hyderabad site to manage post-market surveillance, adverse event/product complaint analysis, literature reviews, and support safety documentation. This role is critical in maintaining global compliance with safety regulations for medical devices and combination products.
Key Responsibilities:
Conduct correlation analysis between product complaints and adverse events.
Perform post-market surveillance and literature reviews for medical devices.
Pull and analyze data for Global Periodic Safety Reports (PSUR), Medical Device Regulation (MDR), and Clinical Evaluation Reports (CER).
Evaluate external safety data (e.g., MAUDE, FAERs databases).
Reconcile AE and product complaint excursions for trending and impact assessment.
Analyze regulatory intelligence and assess impact on safety surveillance.
Generate safety metrics for governance forums and support audits/inspections.
Required Skills & Qualifications:
8+ years (Doctorate) or 9+ years (Bachelor’s/Master’s) in post-market surveillance and data analysis.
Experience in safety monitoring within pharma or biotech.
Proficiency in product complaints and adverse event processing.
Familiarity with global medical device safety regulations and combination products.
Strong data analysis skills; proficiency with tools such as Power BI, Tableau, or Python.
Excellent problem-solving and scientific thinking.
Strong communication and teamwork capabilities.
Competency in MS Office (Excel, Word, Outlook, PowerPoint).
Preferred Skills:
Deep understanding of MDR, PSUR, and CER requirements.
Ability to derive insights from data analytics.
Experience working in a matrix organization.
Strong time management and prioritization.
Perks & Benefits:
Work with one of the world's leading biotechnology companies.
Exposure to global safety surveillance processes and regulatory standards.
Collaborative and innovation-driven work culture.
Career growth in medical device and combination product safety.
Company Description:
Amgen is a global leader in biotechnology, developing innovative therapies to treat serious illnesses. Its Hyderabad site is a strategic hub for advancing medical device safety, pharmacovigilance, and regulatory excellence across its global operations.
Work Mode: On-site (Hyderabad, India)
Call to Action:
Are you a safety expert with a passion for post-market vigilance and regulatory compliance? Apply now to join Amgen's safety team and make an impact in global patient safety.
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