Amgen Pharmacovigilance Hiring Case Management – Specialist (Device Safety)

Amgen Hiring Case Management – Specialist (Device Safety) | Life Sciences | Hyderabad

Amgen is hiring for the position of Case Management – Specialist (Device Safety) at its Hyderabad, India location. This is an on-site role within the Pharmacovigilance and Drug Safety function, supporting global device and combination product safety operations. The opportunity is suited for experienced professionals in drug safety, pharmacovigilance, life sciences, or medical device safety who meet the required academic and experience criteria.

If you are looking for pharmacovigilance jobs in Hyderabad, drug safety specialist roles in biotech, or ICSR case processing careers in global regulatory environments, this position offers exposure to FDA, EMA, and worldwide regulatory reporting within a leading biotechnology company.

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Company Overview

Amgen is one of the world’s pioneering biotechnology companies, founded in 1980 with a clear mission to serve patients living with serious illnesses. With a strong presence across Oncology, Inflammation, General Medicine, and Rare Diseases, Amgen develops and delivers innovative biologic therapies that reach millions of patients globally.

The company operates in highly regulated international markets and maintains strict compliance with global pharmacovigilance regulations, Good Manufacturing Practices (GMP), and Good Pharmacovigilance Practices (GVP). Amgen’s culture is science-driven, collaborative, and grounded in strong ethical standards. Employees contribute directly to advancing biotechnology innovation while ensuring patient safety remains the top priority.

The Device Safety and Case Management team plays a critical role in monitoring adverse events, ensuring regulatory reporting compliance, and maintaining inspection readiness across global health authorities.

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Job Role & Responsibilities

The Case Management – Specialist (Device Safety) will be accountable for the quality and compliance of Individual Case Safety Reports (ICSRs) related to device and combination products for both clinical trial and post-market cases.

Key Responsibilities

• Oversee global processing of device and combination product ICSRs.
• Ensure high-quality case intake, review, and submission in compliance with FDA, EMA, and other regulatory authority requirements.
• Act as US/EU local safety office contact point for regulatory reporting.
• Submit Individual Case Safety Reports to health authorities, license partners, and vendors.
• Monitor vendor performance, analyze quality metrics, and identify trends in case processing.
• Ensure vendor compliance with approved pharmacovigilance processes and training requirements.
• Support audit readiness and external regulatory inspections.
• Undertake delegated activities from the Qualified Person for Pharmacovigilance (QPPV) as outlined in the PV System Master File.
• Assist with Periodic Aggregate Safety Reports (PASR) and lifecycle safety reporting activities when applicable.

Operational & Compliance Activities

• Work within Amgen’s Quality Management System framework.
• Ensure timely reporting and regulatory compliance for device safety cases.
• Implement Standard Operating Procedures (SOPs) for pharmacovigilance case management.
• Contribute to system improvements and process enhancements related to case intake.
• Maintain quality of Product Complaints (PC), Adverse Event (AE), and other safety records.
• Apply analytical skills to assess moderately complex safety cases across multiple systems.

This role demands strong regulatory awareness, attention to detail, and the ability to manage strict reporting timelines. Accurate case processing directly impacts patient safety, regulatory compliance, and global product integrity.

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Eligibility & Qualifications

Amgen is seeking highly experienced professionals with a strong academic background and substantial exposure to drug safety or life sciences functions.

Basic Qualification Criteria

One of the following combinations is required:

• 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

Preferred Education Background

Bachelor’s or higher degree in health-care or scientific disciplines such as:

B.Pharm, M.Pharm, Pharm.D, MBBS, BDS, BSc Nursing, MSc Nursing, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Biomedical Sciences, or related clinical and pharmaceutical sciences fields.

Preferred Experience

• Experience in Pharmacovigilance or Quality within biotech, pharmaceutical, or medical device industries.
• Hands-on exposure to safety databases or corporate intake systems.
• Familiarity with global safety reporting regulations.
• Experience supporting audits and regulatory inspections.

Required Skills & Competencies

• Strong understanding of Good Pharmacovigilance Practices (GVP) and Good Manufacturing Practices (GMP).
• Familiarity with clinical development processes.
• High case-level productivity and quality standards.
• Strong analytical and documentation skills.
• Ability to work in a matrixed team environment.
• Proficiency in Microsoft Office tools including Word, Excel, PowerPoint, Project, and Outlook.
• Ability to manage strict timelines and deliver high-quality results consistently.

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Location & Salary

Location: Hyderabad, India
Work Model: On-Site
Department: Pharmacovigilance / Device Safety / Case Management
Job ID: R-236207

Amgen offers competitive compensation aligned with industry standards for senior pharmacovigilance and drug safety professionals in India. In addition to base salary, employees receive comprehensive total rewards, benefits, and career development support.

The organization emphasizes professional growth, collaborative teamwork, and a supportive work environment focused on scientific excellence and patient safety.

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Application Process

Interested candidates can apply directly through Amgen’s official career portal using the link below:

Apply Here:
https://careers.amgen.com/en/job/-/-/87/91610855360

Application Tips

• Clearly mention experience in ICSR processing and safety reporting.
• Highlight exposure to FDA, EMA, or global regulatory submissions.
• Include audit or inspection support experience if applicable.
• Detail experience with pharmacovigilance databases and vendor oversight.

Shortlisted candidates will be contacted for further evaluation.

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Frequently Asked Questions (FAQs)

1. Is this role suitable for freshers?

No. This role requires significant experience in drug safety or life sciences.

2. Is pharmacovigilance experience mandatory?

Yes. Experience in drug safety, pharmacovigilance, or related quality functions is essential.

3. What type of reports will be handled?

The role involves Individual Case Safety Reports (ICSRs) and may support Periodic Aggregate Safety Reports (PASR).

4. Is this role regulatory-facing?

Yes. The specialist interacts with regulatory authorities such as FDA and EMA for safety reporting.

5. Is this a global role?

Yes. The position supports global device and combination product case management.

6. What career growth can be expected?

Professionals can advance to Senior Safety Specialist, Safety Manager, Global PV Lead, or Regulatory Safety Leadership roles.

Company	Amgen
Vacancies	Case Management – Specialist (Device Safety)
Required Education	Doctorate, Master’s, or Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Biotechnology, Nursing or related healthcare/scientific fields
Experience	4–9+ years in Drug Safety, Pharmacovigilance, or Life Sciences (as per qualification criteria)

Tagged as: Pharma Jobs in Hyderabad