Amgen has announced three new openings in Hyderabad for professionals in clinical trial delivery and pharmacovigilance operations. The available positions include Study Delivery Associate, Senior Associate Pharmacovigilance Operations, and Pharmacovigilance Operations Manager.

These full-time, on-site opportunities are suitable for candidates with experience in clinical research, CTMS, eTMF, ICSR case processing, safety systems, vendor management, regulatory compliance, and pharmacovigilance operations.

Quick Answer: Amgen is hiring for three Clinical and Pharmacovigilance roles in Hyderabad. Candidates with relevant educational qualifications and experience in clinical trials, ICSR processing, safety operations, CTMS, eTMF or vendor oversight can apply.

Amgen Hiring 2026 Overview

Available Positions

1. Study Delivery Associate

Job Requisition ID: R-243231
Career Category: Clinical
Estimated salary: ₹5–8 lakh per annum

The Study Delivery Associate provides administrative and operational support for clinical trial management. The selected candidate will assist study teams in meeting timelines, maintaining clinical systems and ensuring inspection-ready documentation.

Key Responsibilities

• Support study-level trackers, dashboards and timelines.
• Communicate study progress and deliverables to the Study Delivery Manager.
• Track study actions and follow up on risk-mitigation activities.
• Assist with risk and quality review documentation.
• Coordinate study-team training and inspection-readiness activities.
• Support investigator meetings, global site communications and logistics.
• Assist with study start-up, system setup and supplier-access management.
• Track informed consent forms and study-document readiness.
• Support vendor relationships and site-engagement activities.
• Manage the shipment and reconciliation of biological samples.
• Coordinate investigational-product logistics and reconciliation.
• Maintain timely and accurate information in CTMS and study-training systems.
• Process system-access requests.
• Prepare and maintain monitoring plans, regulatory documents and study guides.
• Support Trial Master File filing and document management.
• Contribute to process improvement and knowledge-sharing initiatives.

Qualification and Experience

Candidates must meet one of the following requirements:

• Bachelor’s degree; or
• Associate’s degree with four years of clinical execution experience; or
• High school diploma/GED with six years of clinical execution experience.

Amgen preferably seeks candidates with:

• Two years of experience in a life sciences or medically related field.
• At least one year of biopharmaceutical clinical research experience.
• Experience working in a biotechnology, pharmaceutical or CRO company.
• Exposure to global clinical trials.

A bachelor’s degree meets the stated basic qualification, but applicants with relevant clinical-research exposure will have a stronger profile.

Skills Required

Technical skills

• CTMS, eTMF and EDC systems
• Microsoft Word, Excel and PowerPoint
• Study trackers and clinical dashboards
• Clinical document filing and version control
• Accurate clinical-system data entry

Domain skills

• Clinical trial coordination
• Study start-up support
• Informed consent form tracking
• TMF filing and inspection readiness
• Regulatory documentation
• Biological sample and investigational-product logistics

Soft skills

• Attention to detail
• Global-team collaboration
• Problem-solving ability
• Organizational and time-management skills
• Willingness to learn new activities

Apply for Study Delivery Associate

2. Senior Associate Pharmacovigilance Operations

Job Requisition ID: R-251859
Career Category: Safety
Estimated salary: ₹8–14 lakh per annum

The Senior Associate Pharmacovigilance Operations will support ICSR processing, case review, vendor oversight, expedited safety reporting and regulatory compliance.

Key Responsibilities

• Support vendors handling safety-case intake and processing.
• Review individual case safety reports for quality and completeness.
• Escalate case-level processing and data-entry issues.
• Respond to queries related to intake, triage and ICSR data entry.
• Determine whether cases require expedited reporting to the FDA, EMA or business partners.
• Ensure reportable ICSRs are submitted within regulatory and contractual timelines.
• Conduct US case follow-up activities.
• Support ICSR literature-review processes.
• Initiate unblinding when requested.
• Provide local affiliate office E2B support, including nullification and redistribution.
• Perform business-partner reconciliation under safety agreements.
• Support reportable-event reconciliation for sponsored clinical trials.
• Develop and deliver case-management convention training.
• Support QPPV-delegated activities documented in the Pharmacovigilance System Master File.
• Maintain audit and health-authority inspection readiness.

Qualification and Experience

Candidates must meet one of the following requirements:

• Bachelor’s degree with two years of directly related experience; or
• Associate’s degree with six years of directly related experience; or
• High school diploma/GED with eight years of directly related experience.

Candidates with a bachelor’s degree in Pharmacy, Life Sciences, Medicine, Nursing, Biotechnology or another medically related discipline, along with at least two years of direct pharmacovigilance experience, may be suitable.

Skills Required

Technical skills

• Safety database or pharmacovigilance system proficiency
• ICSR intake, triage and data entry
• Case review and follow-up
• E2B case transmission support
• Microsoft Word, Excel, PowerPoint, Project and Outlook

Domain skills

• Global pharmacovigilance regulations
• FDA and EMA expedited reporting
• Case reportability assessment
• Business-partner reconciliation
• Literature case processing
• Clinical-trial safety reconciliation
• Inspection and audit readiness

Soft skills

• Strong attention to detail
• Query-management ability
• Quality-focused decision-making
• Communication and stakeholder coordination
• Ability to escalate issues appropriately

Apply for Senior Associate PV Operations

3. Pharmacovigilance Operations Manager

Job Requisition ID: R-251860
Career Category: Safety
Estimated salary: ₹16–25 lakh per annum

The Pharmacovigilance Operations Manager will oversee ICSR operations, vendor performance, case-processing compliance, safety training, quality trends and inspection-readiness activities.

Key Responsibilities

• Oversee timely and high-quality ICSR processing.
• Manage day-to-day case-processing vendor activities.
• Ensure vendors receive appropriate resources, onboarding and training.
• Monitor adverse-event intake, triage and submission timelines.
• Assess workloads and support resource allocation.
• Analyse case-quality-control findings and trends.
• Recommend corrective and preventive actions based on quality findings.
• Generate, communicate and archive QC reports.
• Lead the development of case-management training materials.
• Manage multiple business-partner relationships.
• Review safety-data exchange contract wording.
• Monitor compliance with regulatory and contractual requirements.
• Assign activities to direct and indirect team members.
• Escalate significant case-processing issues.
• Generate performance metrics covering volumes, compliance and turnaround times.
• Support vendor audits, internal audits and regulatory inspections.
• Perform case review, follow-up and business-partner reconciliation when required.
• Maintain inspection readiness for delegated QPPV activities.

Qualification and Experience

Candidates must meet one of the following requirements:

• Master’s degree with three years of directly related experience; or
• Bachelor’s degree with five years of directly related experience; or
• Associate’s degree with ten years of directly related experience; or
• High school diploma/GED with twelve years of directly related experience.

Applicants must also have previous experience managing teams, projects, programmes or resource allocation.

Professionals with qualifications in Pharmacy, Life Sciences, Medicine, Nursing, Biotechnology or a related discipline and strong pharmacovigilance operations experience may be suitable.

Skills Required

Technical skills

• Pharmacovigilance safety systems
• ICSR processing and case review
• Quality-control trend analysis
• Compliance and performance reporting
• Microsoft Word, Excel, PowerPoint, Project and Outlook

Domain skills

• Global pharmacovigilance regulations
• Vendor and business-partner oversight
• Safety-data exchange agreements
• CAPA and quality management
• Regulatory inspections and internal audits
• QPPV and PSMF-related activities
• Safety-operations resource management

Soft skills

• Project and team leadership
• Vendor-management ability
• Decision-making and escalation
• Stakeholder communication
• Analytical and problem-solving skills

Apply for Pharmacovigilance Operations Manager

Estimated Salary at Amgen

Amgen has not disclosed compensation for these openings. Based on the role level, location and experience requirements, the estimated annual salary ranges are:

These figures are estimates and may vary according to experience, current compensation, specialised skills and Amgen’s internal salary structure.

Benefits

Benefits were not clearly specified in the job descriptions.

How to Apply

Apply for Study Delivery Associate

Apply for Senior Associate PV Operations

Apply for Pharmacovigilance Operations Manager