Amgen Technology is inviting applications for the position of Senior Associate, Pharmacovigilance Operations in Hyderabad, Telangana. Candidates with 2–5 years of experience and a graduate or postgraduate qualification can explore this opportunity in pharmacovigilance and drug safety reporting. The role focuses on preparing, compiling, reviewing, and managing Periodic Aggregate Safety Reports (PASRs) in accordance with applicable regulatory requirements. Professionals with experience in safety report authoring, clinical research documentation, quality review, and regulatory compliance are encouraged to apply.
Amgen Senior Associate Pharmacovigilance Operations Recruitment
Company Overview
Amgen is a biotechnology company focused on developing medicines for serious diseases. Its operations include activities supporting drug development, patient safety, and regulatory compliance.
Job Details
- Company: Amgen Technology
- Designation: Senior Associate, Pharmacovigilance Operations
- Department: Pharmacovigilance Operations
- Job Location: Hyderabad, Telangana, India
- Experience: 2–5 years
- Employment Type: Full-time, Permanent
- Industry: Pharmaceutical and Life Sciences
- Salary: Not disclosed
Job Role & Responsibilities
The selected candidate will support the end-to-end preparation and management of Periodic Aggregate Safety Reports (PASRs). The role involves coordinating report contributions, authoring safety content, conducting quality reviews, managing approvals, and ensuring reports are completed within regulatory timelines.
Key Responsibilities
PASR Compilation and Authoring
- Compile and author periodic aggregate safety reports in accordance with global regulatory requirements.
- Support the preparation of Development Safety Update Reports (DSURs).
- Work on Periodic Benefit-Risk Evaluation Reports (PBRERs) and Periodic Safety Update Reports (PSURs).
- Support preparation of Semi-Annual Safety Update Reports (SSURs), Periodic Adverse Drug Experience Reports (PADERs/PAERs), and Device PSURs.
- Assist with country-specific reports, including Korea PSURs, Brazil PSURs, and Colombia Clinical Research Annual Safety Report Submission and Evaluation forms.
- Collaborate with Therapeutic Area Safety Scientists to prepare safety content.
Stakeholder Coordination and Timeline Management
- Schedule and coordinate meetings with cross-functional stakeholders.
- Collect report contributions from internal teams and external business partners.
- Compile submitted content into the appropriate PASR templates.
- Monitor report timelines and escalate risks or delays to team leads and management.
- Coordinate report reviews and resolve comments before final approval.
Quality Review and Documentation
- Conduct peer quality control reviews of authored safety sections.
- Coordinate internal reviews and initiate approval workflows.
- Review and approve published report versions, including blinded, unblinded, EU/FDA, and Rest of World versions, as applicable.
- Maintain and archive accurate report documentation.
- Distribute reports to Contract Research Organizations (CROs) and business partners.
- Perform peer and quality reviews within established timelines using applicable checklists.
Regulatory Compliance and Reporting Metrics
- Ensure compliance with regulatory guidelines, internal processes, report styles, and applicable standards.
- Maintain current knowledge of regulatory requirements, technological developments, and industry practices.
- Generate Periodic Aggregate Safety Report metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
Literature Management
- Assist with literature management activities when required.
Eligibility & Qualifications
Educational Qualifications
The recruitment listing specifies the following educational requirements:
- Any graduate.
- Any postgraduate.
Experience Required
- 2–5 years of professional experience.
- Relevant experience in pharmacovigilance operations, periodic safety reporting, safety report authoring, or regulatory documentation would be applicable to the responsibilities of this position.
Relevant Skills
- Pharmacovigilance operations.
- Periodic Aggregate Safety Report (PASR) compilation.
- Safety report authoring and quality control.
- Development Safety Update Report (DSUR).
- Periodic Benefit-Risk Evaluation Report (PBRER).
- Periodic Safety Update Report (PSUR).
- PADER and related regulatory reports.
- Clinical research documentation.
- Regulatory compliance.
- Stakeholder coordination and workflow management.
- Literature management.
- Reporting metrics and quality review.
Location & Salary
- Job Location: Hyderabad, Telangana, India.
- Salary: Not disclosed in the recruitment listing.
- Employment Type: Full-time, permanent.
Candidates should confirm compensation and other employment terms during the recruitment process.
How to Apply
Interested candidates can apply through the job listing on Naukri.
Application Process
- Open the job listing using the link below.
- Review the job responsibilities and eligibility requirements.
- Update your resume to include relevant pharmacovigilance, safety reporting, and regulatory documentation experience.
- Complete the application process through the recruitment portal.
- Monitor your registered email and phone for further communication.
Apply Here: Amgen Senior Associate Pharmacovigilance Operations
Selection Process
The supplied recruitment listing does not specify the interview rounds or selection stages. Applicants should follow the instructions provided through the recruitment portal.
Important Dates
Candidates should refer to the official recruitment listing for the latest application status and availability.
Documents Required
Keep the following documents ready, as applicable:
- Updated resume or CV.
- Educational certificates and mark sheets.
- Relevant work experience details.
- Information about pharmacovigilance and safety reporting experience.
- Valid contact information.
Additional Requirements
- Ability to manage multiple reports and deadlines.
- Strong attention to detail during report preparation and quality review.
- Effective communication with cross-functional teams and external partners.
- Understanding of regulatory reporting processes and applicable guidelines.
- Ability to maintain accurate documentation and follow established workflows.
- Willingness to support literature management activities when required.
Frequently Asked Questions
1. What qualification is required for the Amgen Senior Associate Pharmacovigilance Operations position?
The recruitment listing specifies any graduate or any postgraduate qualification.
2. How much experience is required?
Candidates should have 2–5 years of experience.
3. Where is the job located?
The position is listed in Hyderabad, Telangana, India.
4. What are the main responsibilities?
The role involves PASR compilation and authoring, safety report quality review, stakeholder coordination, regulatory compliance, report distribution, and documentation management.
5. What is the salary offered by Amgen?
The salary is not disclosed in the supplied recruitment listing. Candidates should confirm compensation during the hiring process.
6. How can candidates apply?
Candidates can submit their applications through the Naukri job listing linked above.
Job Summary Table
| Category | Details |
|---|---|
| Company | Amgen Technology |
| Vacancies | Senior Associate, Pharmacovigilance Operations |
| Required Education | Any Graduate or Any Postgraduate |
| Experience | 2–5 years |
| Location | Hyderabad, Telangana, India |