Device Safety Case Management Specialist Job in Hyderabad at Amgen Experienced pharmacovigilance professionals apply online for global regulatory role.
The global pharmacovigilance and device safety domain continues to expand as regulatory expectations grow stronger worldwide. If you have substantial experience in drug safety, medical device vigilance, or pharmacovigilance quality systems, this senior-level opportunity in Hyderabad may align with your career goals. Amgen is currently hiring for the position of Case Management – Specialist (Device Safety) for its on-site Hyderabad location.
This role is suited for experienced professionals who can manage Individual Case Safety Reports (ICSRs), vendor oversight, regulatory compliance, and global safety reporting processes. Device Safety Case Management Specialist Job in Hyderabad at Amgen
Company Overview
Amgen is a globally recognized biotechnology company established in 1980, focused on discovering, developing, and delivering innovative therapies. The organization operates across major therapeutic areas including oncology, inflammation, general medicine, and rare diseases. With a strong global presence, Amgen integrates science-driven research, manufacturing excellence, and regulatory compliance to serve patients with serious illnesses.
The company promotes a collaborative and innovation-focused work culture, emphasizing regulatory integrity, scientific excellence, and patient safety. Device Safety Case Management Specialist Job in Hyderabad at Amgen
Job Location & Employment Type
- Job Title: Case Management – Specialist (Device Safety)
- Job ID: R-236207
- Location: Hyderabad, India
- Work Mode: On-Site
- Department Category: Information Systems / Pharmacovigilance
- Employment Type: Full-Time
This is a mid-to-senior level position requiring extensive experience in drug safety or life sciences. Device Safety Case Management Specialist Job in Hyderabad at Amgen
Department & Functional Area
The role operates within the Global Pharmacovigilance and Device Safety framework. The selected candidate will work closely with: Device Safety Case Management Specialist Job in Hyderabad at Amgen
- License partners
- Vendors
- Regulatory authorities (FDA/EMA)
- Qualified Person for Pharmacovigilance (QPPV)
- Quality and compliance teams
The position involves oversight of device and combination product safety case processing globally.
Key Roles & Responsibilities
The Device Safety Specialist will be accountable for ensuring quality, regulatory compliance, and inspection readiness across case management processes.
Core Responsibilities
- Oversee global processing of device and combination product ICSRs for clinical trials and post-market surveillance.
- Monitor vendor performance for case intake and processing quality.
- Ensure compliance with worldwide regulatory reporting timelines.
- Support submissions of safety reports to FDA, EMA, and business partners.
- Act as US/EU local safety office contact for safety reporting.
- Identify and escalate device-related case management issues.
- Ensure inspection readiness and provide audit support.
- Support activities delegated by the QPPV as outlined in the PV System Master File.
- Assist with Periodic Aggregate Safety Report (PASR) processes when applicable.
Operational & Compliance Activities
- Work within the established Quality Management System.
- Maintain training compliance and controlled documentation standards.
- Ensure proper documentation of Product Complaints (PC), Adverse Events (AE), and other safety records.
- Implement SOP requirements related to device and combination product vigilance.
- Contribute to process improvements and intake system implementation.
- Analyze trends in case quality metrics and generate reports.
- Apply analytical thinking to moderately complex safety scenarios.
Device Safety Case Management Specialist Job in Hyderabad at Amgen
Eligibility Criteria
Basic Qualifications
Candidates must meet one of the following educational and experience criteria:
- Doctorate degree with 4 years of Drug Safety or Life Sciences experience
OR - Master’s degree with 7 years of Drug Safety or Life Sciences experience
OR - Bachelor’s degree with 9 years of Drug Safety or Life Sciences experience
This is not a fresher role. Significant professional experience in pharmacovigilance or related fields is mandatory. Device Safety Case Management Specialist Job in Hyderabad at Amgen
Preferred Qualifications
- Experience in pharmacovigilance, drug safety, or quality systems in biotech, pharmaceutical, or medical device industries.
- Bachelor’s degree in a healthcare or scientific discipline.
- Experience working with safety databases or corporate intake systems.
- Exposure to vendor oversight and regulatory audits.
- Familiarity with project management tools.
- Proven ability to meet strict timelines and maintain high-quality outputs.
- Ability to function effectively in matrix or cross-functional teams.
Technical & Functional Skills Required
- Strong knowledge of global regulatory frameworks including Good Pharmacovigilance Practices (GVP) and Good Manufacturing Practices (GMP).
- Understanding of the clinical development lifecycle.
- High attention to detail in safety case documentation.
- Analytical skills for evaluating moderately complex safety data.
- Strong productivity and case-level accuracy.
- Proficiency in Microsoft Office tools including Word, Excel, PowerPoint, Project, and Outlook.
- Effective communication skills for interacting with global stakeholders.
Salary & Benefits
Salary details have not been publicly disclosed and will be offered as per company norms based on experience and qualifications. Device Safety Case Management Specialist Job in Hyderabad at Amgen
Amgen offers competitive total rewards aligned with industry standards, including:
- Comprehensive benefits package
- Professional development opportunities
- Collaborative and inclusive work environment
- Structured performance management systems
Detailed compensation and benefits information will be discussed during the recruitment process.
Selection Process
The recruitment process may include:
- Online application submission.
- Resume screening.
- Technical interview(s) focusing on pharmacovigilance and device safety.
- Compliance and regulatory discussion round.
- HR and compensation discussion.
- Final selection and offer release.
Candidates should prepare thoroughly in global PV regulations, device vigilance, and ICSR processing standards.
How to Apply
Eligible and interested candidates can apply directly through the official Amgen careers portal.
Visit: careers.amgen.com
Search using Job ID: R-236207
Location: Hyderabad, India
Applications must be submitted online through the company’s official recruitment system.
Important Dates
- No specific application deadline mentioned. Early application is recommended.
Why Apply for This Pharmacovigilance Role?
This position offers significant professional value for experienced pharmacovigilance specialists:
- Opportunity to work with a globally recognized biotechnology organization.
- Exposure to global regulatory frameworks (FDA, EMA).
- Hands-on involvement in device and combination product vigilance.
- Direct engagement with QPPV and regulatory authorities.
- Experience in audit and inspection readiness processes.
- Career advancement within global drug safety operations.
For professionals seeking leadership-level responsibility in device safety and pharmacovigilance compliance, this role provides international exposure and high-impact responsibilities. Device Safety Case Management Specialist Job in Hyderabad at Amgen
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares employment opportunities for informational purposes only. We are not affiliated with Amgen or its recruitment team. Candidates are advised to verify all job details directly from the official company website before applying. We do not charge any fee for job postings or applications. Device Safety Case Management Specialist Job in Hyderabad at Amgen
Final Call-to-Action
If you meet the required experience and qualifications in drug safety or pharmacovigilance, consider applying for this Device Safety Specialist role in Hyderabad. Ensure your resume highlights ICSR processing, regulatory compliance expertise, and vendor management experience before submitting your online application. Take the next step toward advancing your global pharmacovigilance career. Device Safety Case Management Specialist Job in Hyderabad at Amgen
