Senior Associate Pharmacovigilance Operations Job at Amgen in Hyderabad, India
Amgen is hiring for the position of Senior Associate – Pharmacovigilance Operations in Hyderabad, India. This is a full-time, on-site opportunity within the Medical Services career category, designed for experienced pharmacovigilance professionals with strong expertise in global safety reporting, ICSR processing, and regulatory compliance.
This role plays a critical function in supporting US and EU safety operations, acting as a key point of contact for FDA and EMA safety reporting, vendor oversight, and inspection readiness activities. Senior Associate Pharmacovigilance Operations Job
Job Details
- Job Title: Senior Associate – Pharmacovigilance Operations
- Job Requisition ID: R-233379
- Company: Amgen
- Location: Hyderabad, India
- Work Type: On Site
- Employment Type: Full Time
- Career Category: Medical Services
About the Company
Amgen is a global biotechnology leader dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong presence across major global markets, Amgen is known for its science-driven culture, commitment to patient safety, and excellence in regulatory and pharmacovigilance practices. Senior Associate Pharmacovigilance Operations Job
The organization maintains robust global safety systems to ensure compliance with international health authority regulations and to protect patient well-being throughout the product lifecycle. Working at Amgen provides professionals with exposure to complex global safety operations, cutting-edge systems, and high-impact regulatory responsibilities.
Group Purpose
The Pharmacovigilance Operations group functions as a US and EU Local Safety Office, serving as a primary point of contact for regulatory authorities such as the FDA and EMA. The team is responsible for safety case intake, processing, reporting, vendor oversight, quality trend analysis, and regulatory inspection readiness. Senior Associate Pharmacovigilance Operations Job
This role supports global safety reporting obligations and ensures compliance with regulatory timelines, contractual agreements, and internal quality standards. Senior Associate Pharmacovigilance Operations Job
Job Summary
The Senior Associate – Pharmacovigilance Operations is responsible for managing and supporting pharmacovigilance activities related to clinical trials and post-marketing safety reporting. The role involves extensive interaction with vendors, business partners, internal stakeholders, and regulatory authorities.
The position requires hands-on experience in case processing, reconciliation, vendor oversight, and expedited safety reporting to FDA and EMA, while ensuring adherence to global pharmacovigilance regulations and company procedures.
Key Responsibilities
- Act as a US/EU local safety office representative and point of contact for FDA and EMA safety reporting
- Support submission of Individual Case Safety Reports (ICSRs) to FDA, EMA, and business partners
- Support reconciliation of reportable events for Amgen-sponsored clinical trials
- Oversee vendor case intake, processing, and reconciliation activities
- Perform detailed case review and ensure high-quality safety data
- Escalate case-level and data entry issues as required
- Support intake, triage, and data entry query management for ICSRs
- Make reporting decisions for expedited safety reports in compliance with regulations and contracts
- Ensure ICSRs are submitted within regulatory and contractual timelines
- Support business partner reconciliation activities per safety agreements
- Undertake responsibilities delegated by the QPPV as outlined in the Pharmacovigilance System Master File
- Maintain a continuous state of inspection readiness
- Represent pharmacovigilance operations during health authority inspections and internal audits
- Support convention-related and process-related training delivery
- Perform additional duties as defined in standard operating procedures or assigned by management
Senior Associate Pharmacovigilance Operations Job
Key Activities
- Perform reportable event reconciliation by reviewing non-matching safety data across clinical and safety databases
- Oversee and manage vendor clinical safety reconciliation teams
- Ensure timely and high-quality ICSR processing meeting global regulatory requirements
- Conduct US case follow-up activities
- Review and respond to adverse event intake, triage, and submission queries
- Initiate unblinding activities when required
- Select cases for reporting to FDA, EMA, and business partners based on regulatory and contractual requirements
- Ensure compliance with reporting timelines and criteria
- Interface with local safety offices, vendors, and business partners for case processing
- Provide Local Affiliate Office (LAO) E2B support, including nullification and redistribution
- Support ICSR literature review activities
- Assist with additional case processing functions as required
Senior Associate Pharmacovigilance Operations Job
Knowledge and Skills
- Strong understanding of global pharmacovigilance regulatory requirements
- In-depth knowledge of FDA and EMA safety reporting regulations
- Familiarity with the clinical development process
- Proven experience in safety case processing with high productivity and quality
- Strong attention to detail and data accuracy
- Proficiency in pharmacovigilance safety databases
- Strong working knowledge of Microsoft Office tools, including Word, Excel, PowerPoint, Outlook, and Project
- Effective communication and stakeholder management skills
- Ability to work independently while collaborating with cross-functional and global teams
Senior Associate Pharmacovigilance Operations Job
Education and Experience
Educational Qualification
- Bachelor’s degree in a relevant scientific or healthcare discipline
Experience Requirement
- Minimum 5+ years of directly related experience in pharmacovigilance or drug safety operations
Why You Should Join Amgen
- Opportunity to work with a global biotechnology leader
- Exposure to complex US and EU pharmacovigilance operations
- Direct involvement in FDA and EMA safety reporting
- Strong focus on quality, compliance, and patient safety
- Professional growth in advanced pharmacovigilance and regulatory roles
- Collaborative and science-driven work environment
- Long-term career development within global medical services
Senior Associate Pharmacovigilance Operations Job
Frequently Asked Questions (FAQs)
Is this role remote or on-site?
This position is on-site and based in Hyderabad, India.
What level of experience is required?
Candidates must have at least 5 years of directly related pharmacovigilance experience.
Will this role involve interaction with regulatory authorities?
Yes, the role supports safety reporting and inspection readiness related to FDA and EMA.
Is vendor oversight part of the role?
Yes, vendor oversight for case intake, processing, reconciliation, and quality is a core responsibility.
What safety systems knowledge is required?
Hands-on experience with pharmacovigilance safety databases and E2B reporting is expected.
How to Apply
Senior Associate Pharmacovigilance Operations Job
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