Global Safety Senior Manager
Location: Hyderabad, India
Job ID: R-219494
Posted On: June 30, 2025
Work Type: On-Site | Full-Time
Category: Safety
About the Role:
Amgen’s Global Safety Senior Manager is a leadership role within the Therapeutic Area Safety Team, accountable for defining and executing the safety strategy for Amgen products. This individual will oversee major safety deliverables, signal management, risk assessments, regulatory responses, and safety content in support of filings. The position demands strategic vision, cross-functional collaboration, and advanced expertise in pharmacovigilance (PV).
Key Responsibilities:
Safety Strategy & Aggregate Report Leadership:
Lead planning, writing, and reviewing portions of aggregate safety reports.
Guide affiliates and internal partners regarding safety deliverables and strategy.
Oversee review and interpretation of AE/SAEs from clinical trials.
Provide input into protocols, SAPs, CRFs, and safety-relevant study documents.
Direct safety signal detection and lead evaluation and documentation efforts.
Collaborate with GSOs to develop and update Risk Management Plans.
Regulatory Filings & Inspection Readiness:
Prepare responses to regulatory safety inquiries.
Contribute to safety content for new drug applications and other filings.
Represent safety in audits and inspections as the delegated QPPV contact.
Maintain inspection readiness aligned with global PV standards.
Risk Management & Signal Oversight:
Evaluate risk minimization activities and propose improvement strategies.
Present safety assessments to cross-functional governance bodies.
Monitor safety trends via literature, safety databases, and real-world evidence.
Required Knowledge & Skills:
Expert knowledge of global pharmacovigilance regulations and risk management.
Proficient in safety signal detection, evaluation, and risk mitigation.
Working knowledge of MedDRA, safety databases, and aggregate data analysis.
Strong scientific writing and communication skills for cross-functional collaboration.
Advanced project leadership and stakeholder management capabilities.
Intermediate application of statistical/epidemiological tools to safety assessments.
Strategic planning, critical thinking, and problem-solving aptitude.
Qualifications:
Basic Requirements:
Education: Doctorate, Master’s, or Bachelor’s in Life Sciences or related field.
Experience: 12–17 years of directly relevant experience in pharmacovigilance or clinical research.
Preferred Requirements:
BS/BA in Life Sciences with MS and minimum 12 years of related experience.
2+ years of managerial or team leadership experience.
6+ years in biotech, pharmaceutical, or CRO environment.
Demonstrated experience mentoring teams or leading safety projects.
Estimated Salary: ₹40–55 LPA (based on seniority and team leadership responsibilities)
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Be'Er Sheva | Netanya | Kfar Saba | Tel Aviv | Yavne |Remote :
Xzagreb | Thailand | Switzerland | Remote | Remote, USA | Hungary | Minnesota | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Ireland | French | Manipal | Medan | Melbourne | Springville | Zaragoza | Castlebar | Texas | McFarland | Bishop | Lousiana | Belgium | Green Way | Riga | Victoria | Slovakia | Bountiful | Lenexa | Remote - Africa | Remote - Europe | Faridabad | Blue Bell | Hammond | Remote - Middle East | Remote - South America (Latin Americal) | Tulsa | Leinster |Republic of Colombia :
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Lima |France :
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Niš |Bohemia :
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