Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding Pharmacovigilance Operations – PASR Authoring & Safety Reporting Company: Amgen Location: Hyderabad, Telangana, India Work Location: On-Site Department: Safety / Pharmacovigilance Operations Employment Type: Full-Time Job ID: R-246911 Experience Required: 3–7 Years (estimated based on role complexity and PASR ownership responsibilities) Salary Package Expected CTC: ₹10 LPA – ₹22 LPA (Estimated market range based on pharmacovigilance aggregate reporting experience, PASR authoring skills, regulatory knowledge, and pharmaceutical industry exposure. Actual compensation may vary.) Job Summary The Pharmacovigilance Operations Specialist is responsible for supporting the end-to-end preparation, authoring, compilation, quality review, and submission readiness of global Periodic Aggregate Safety Reports (PASRs). The role focuses on regulatory-compliant safety reporting activities including DSUR, PBRER, PSUR, PADER/PAER, Device PSUR, and country-specific safety reports.

The position requires collaboration with Safety Scientists, Regulatory Affairs, Clinical teams, CROs, and business partners to ensure accurate, high-quality, and timely delivery of safety reports.

Key Responsibilities Periodic Aggregate Safety Report (PASR) Management Support compilation and authoring of global aggregate safety reports, including:

Development Safety Update Reports (DSUR)

Periodic Benefit Risk Evaluation Reports (PBRER)

Periodic Safety Update Reports (PSUR)

Semi Annual Safety Update Reports (SSUR)

Periodic Adverse Drug Experience Reports (PADER/PAER)

Device PSUR

Country-specific safety reports:

Korea PSUR

Brazil PSUR

Colombia Clinical Research Annual Safety Report

Ensure reports are prepared according to:

Global regulatory requirements

Company procedures

Regulatory guidelines

Applicable reporting standards

Report Authoring & Cross-Functional Coordination Coordinate meetings with cross-functional stakeholders to ensure alignment on report deliverables.

Manage PASR timelines, milestones, and deliverables.

Identify potential risks, delays, and issues and escalate appropriately.

Collaborate with

Therapeutic Area Safety Scientists

Regulatory Affairs teams

Clinical Development teams

Medical reviewers

External CROs and business partners

Collect safety contributions from stakeholders and compile content into PASR templates.

Author safety sections of aggregate reports with scientific accuracy and regulatory compliance.

Quality Control & Review Activities Perform peer review and quality checks of PASR sections.

Review safety content for

Accuracy

Completeness

Consistency

Regulatory compliance

Coordinate Amgen review cycles and manage resolution of comments.

Initiate and track approval workflows.

Apply quality review checklists and established procedures.

Review final published report versions, including:

Blinded reports

Unblinded reports

EU reports

FDA reports

Rest of World reports

Documentation & Compliance Management Maintain accurate documentation and audit trails throughout the reporting lifecycle.

Archive finalized reports and supporting documentation.

Manage report distribution to

Contract Research Organizations (CROs)

Business Partners (BPs)

Relevant stakeholders

Ensure compliance with

Pharmacovigilance procedures

Regulatory timelines

Quality standards

PV Metrics & Process Improvement Generate and maintain PASR performance metrics, including:

Key Compliance Indicators (KCIs)

Key Performance Indicators (KPIs)

Monitor reporting timelines and operational performance.

Maintain updated knowledge of

Regulatory guidelines

Industry standards

Pharmacovigilance best practices





Technological advancements

Literature Management Support Support literature management activities as required.

Assist with safety literature review processes.

Ensure relevant safety information is appropriately captured and documented.

Required Qualifications Bachelor’s or Master’s degree in:

Pharmacy

Life Sciences

Medicine

Related healthcare discipline

Experience in Pharmacovigilance operations within:

Pharmaceutical companies

Biotechnology organizations

CRO environments

Required Experience Experience in aggregate safety reporting activities.

Hands-on experience with:

DSUR preparation

PBRER/PSUR authoring

PADER/PAER reporting

Safety document review

Experience coordinating cross-functional safety deliverables.

Understanding of global pharmacovigilance regulations.

Required Skills Strong knowledge of aggregate report lifecycle management.

Good understanding of

ICH E2C guidelines

ICH safety reporting requirements

GVP principles

Global regulatory expectations

Solid medical writing and scientific documentation skills.

Excellent attention to detail and quality focus.

Strong project coordination and timeline management skills.

Ability to manage multiple priorities within strict deadlines.

Strong stakeholder communication and collaboration skills.

Proficiency in Microsoft Office applications, especially:

Word

Excel

PowerPoint

Preferred Skills Experience with global regulatory submissions.

Experience working with health authority reporting requirements.

Knowledge of safety databases and pharmacovigilance systems.

Experience supporting regulatory inspections and audits.

Familiarity with literature surveillance processes.

Experience generating PV compliance metrics.

Career

Opportunity at Amgen Prospect to work on global pharmacovigilance reporting activities.

Exposure to complex safety programs across multiple therapeutic areas.

Collaboration with global safety experts and regulatory teams.

Development opportunities in aggregate reporting, safety surveillance, and PV leadership roles.

Contribution to ensuring patient safety through high-quality regulatory reporting.

Pharmacovigilance

Operations – PASR Authoring & Safety Reporting Company: Amgen Location: Hyderabad, Telangana, India Work Location: On-Site Department: Safety / Pharmacovigilance Operations Employment Type: Full-Time Job ID: R-246911 Experience Required: 3–7 Years (estimated based on role complexity and PASR ownership responsibilities) Salary Package Expected CTC: ₹10 LPA – ₹22 LPA (Estimated market range based on pharmacovigilance aggregate reporting experience, PASR authoring skills, regulatory knowledge, and pharmaceutical industry exposure. Actual compensation may vary.) Key Responsibilities Periodic Aggregate Safety Report (PASR) Management Support compilation and authoring of global aggregate safety reports, including:

Development Safety Update Reports (DSUR)

Periodic Benefit Risk Evaluation Reports (PBRER)

Periodic Safety Update Reports (PSUR)

Semi Annual Safety Update Reports (SSUR)

Periodic Adverse Drug Experience Reports (PADER/PAER)

Device PSUR

Country-specific safety reports:

Korea PSUR

Brazil PSUR

Colombia Clinical Research Annual Safety Report

Ensure reports are prepared according to:

Global regulatory requirements

Company procedures

Regulatory guidelines

Applicable reporting standards





Report Authoring & Cross-Functional Coordination Coordinate meetings with cross-functional stakeholders to ensure alignment on report deliverables.

Manage PASR timelines, milestones, and deliverables.

Identify potential risks, delays, and issues and escalate appropriately.

Collaborate with

Therapeutic Area Safety Scientists

Regulatory Affairs teams

Clinical Development teams

Medical reviewers

External CROs and business partners

Collect safety contributions from stakeholders and compile content into PASR templates.

Author safety sections of aggregate reports with scientific accuracy and regulatory compliance.

Quality Control & Review Activities Perform peer review and quality checks of PASR sections.

Review safety content for

Accuracy

Completeness

Consistency

Regulatory compliance

Coordinate Amgen review cycles and manage resolution of comments.

Initiate and track approval workflows.

Apply quality review checklists and established procedures.

Review final published report versions, including:

Blinded reports

Unblinded reports

EU reports

FDA reports

Rest of World reports

Documentation & Compliance Management Maintain accurate documentation and audit trails throughout the reporting lifecycle.

Archive finalized reports and supporting documentation.

Manage report distribution to

Contract Research Organizations (CROs)

Business Partners (BPs)

Relevant stakeholders

Ensure compliance with

Pharmacovigilance procedures

Regulatory timelines

Quality standards

PV Metrics & Process Improvement Generate and maintain PASR performance metrics, including:

Key Compliance Indicators (KCIs)

Key Performance Indicators (KPIs)

Monitor reporting timelines and operational performance.

Maintain updated knowledge of

Regulatory guidelines

Industry standards

Pharmacovigilance best practices

Technological advancements

Literature Management Support Support literature management activities as required.

Assist with safety literature review processes.

Ensure relevant safety information is appropriately captured and documented.

Required Qualifications Bachelor’s or Master’s degree in:

Pharmacy

Life Sciences

Medicine

Related healthcare discipline

Experience in Pharmacovigilance operations within:

Pharmaceutical companies

Biotechnology organizations

CRO environments

Required Experience Experience in aggregate safety reporting activities.

Hands-on experience with:

DSUR preparation

PBRER/PSUR authoring

PADER/PAER reporting

Safety document review

Experience coordinating cross-functional safety deliverables.

Understanding of global pharmacovigilance regulations.

Required Skills Strong knowledge of aggregate report lifecycle management.

Good understanding of

ICH E2C guidelines

ICH safety reporting requirements

GVP principles

Global regulatory expectations

Strong medical writing and scientific documentation skills.

Excellent attention to detail and quality focus.

Robust project coordination and timeline management skills.

Ability to manage multiple priorities within strict deadlines.

Strong stakeholder communication and collaboration skills.

Proficiency in Microsoft Office applications, especially:

Word

Excel

PowerPoint

Preferred Skills Experience with global regulatory submissions.

Experience working with health authority reporting requirements.

Knowledge of safety databases and pharmacovigilance systems.

Experience supporting regulatory inspections and audits.

Familiarity with literature surveillance processes.

Experience generating PV compliance metrics.

Career

Opportunity at Amgen Opportunity to work on global pharmacovigilance reporting activities.

Exposure to complex safety programs across multiple therapeutic areas.

Collaboration with global safety experts and regulatory teams.

Development opportunities in aggregate reporting, safety surveillance, and PV leadership roles.

Contribution to ensuring patient safety through high-quality regulatory reporting.

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