Global Safety Manager
Location: Hyderabad, India
Job ID: R-218926
Posted On: July 01, 2025
Work Type: On-Site | Full-Time
Category: Safety
About Amgen:
Amgen is a global leader in biotechnology, leveraging cutting-edge science and technology to transform the lives of patients with serious illnesses. For over four decades, Amgen has pioneered innovative therapies across Oncology, Inflammation, General Medicine, and Rare Disease. Join our mission to serve patients while building a meaningful and impactful career.
Position Overview:
As a Global Safety Manager (PV Scientist Manager), you will play a pivotal role in ensuring the safety of Amgen’s clinical and marketed products. You will contribute to signal management, aggregate report writing, regulatory response preparation, and risk management activities across Amgen’s global portfolio. This role requires deep scientific, regulatory, and pharmacovigilance expertise to proactively assess and communicate safety insights that impact patient care and product development.
Key Responsibilities:
Aggregate Reports & Documentation:
Plan, prepare, and review non-medical portions of aggregate safety reports (e.g., DSURs, PBRERs).
Collaborate with affiliates and cross-functional stakeholders to gather and integrate safety data.
Review adverse event (AE) and serious adverse event (SAE) data from clinical trials when needed.
Study Support & Clinical Oversight:
Support study protocols, statistical analysis plans, and case report form development.
Attend clinical study team meetings to represent the safety function.
Review safety tables, figures, listings, and data collection tools.
Signal Detection & Management:
Conduct safety signal detection, data analysis, and authoring of signal evaluation reports.
Collaborate with Global Safety Officers (GSOs) to write and present safety assessment documents.
Search and evaluate data sources, literature, and adverse event data for signal monitoring.
Safety Governance & Communication:
Contribute to safety governance and cross-functional safety team decisions.
Present safety issue assessments and mitigation strategies to decision-making committees.
Risk Management:
Assist in developing and updating risk management plans (RMPs), including region-specific RMPs.
Support tracking and evaluation of risk minimization measures.
Draft responses to Health Authority inquiries on safety risks and mitigation strategies.
Regulatory Support:
Contribute to safety content for regulatory filings and new drug applications (NDAs).
Support regulatory strategies under the guidance of senior scientists or GSOs.
Inspection Readiness:
Maintain compliance with PV System Master File and QPPV-delegated responsibilities.
Serve as a point of contact during internal and external audits and inspections.
Process Improvement:
Participate in the development and standardization of global pharmacovigilance processes.
Drive or support implementation of innovative methods and practices within the therapeutic area.
Basic Qualifications:
Education:
Master’s degree OR
Bachelor’s degree
Experience:
Minimum 9+ years of relevant experience in pharmacovigilance, safety science, regulatory affairs, or clinical development
Required Competencies:
Strong understanding of global pharmacovigilance regulations and safety reporting requirements
Experience in signal detection, aggregate report writing, and regulatory communication
Knowledge of clinical safety data interpretation and case evaluation
Familiarity with RMP development, inspection readiness, and PV systems compliance
Effective written and verbal communication skills with global stakeholders
Analytical thinking, attention to detail, and strong organizational abilities
Estimated Salary: ₹20–28 LPA (based on experience and market standards)
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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 :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
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Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
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 :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Tallinn |Hà Nội :
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Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
Springville | Belgium | Xzagreb | Slovakia | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Castlebar | Lenexa | Leinster | Nairobi | Riga | McFarland | Remote - Europe | Lousiana | Ireland | Green Way | Texas | Faridabad | Blue Bell | Remote, USA | Switzerland | Manipal | Medan | Tulsa | French | Victoria | Zaragoza | Remote - South America (Latin Americal) | Minnesota | Hungary | Remote - Africa | Melbourne | Remote - Middle East | Thailand | Remote | Hammond |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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Sofia |Sweden :
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