**Job Title:** Safety and Medical Quality Lead - Observational Research
**Location:** United Kingdom - Uxbridge (Flex Commuter / Hybrid)
**Additional Locations:** United Kingdom - Remote; United Kingdom - Cambridge
**Category:** Clinical
**Job ID:** R-201431
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### **About Amgen**
Amgen is a global biotechnology leader committed to improving the lives of patients. By tackling serious diseases through innovative research and groundbreaking treatments, Amgen has helped millions worldwide. With a culture rooted in collaboration, scientific excellence, and patient-centered approaches, Amgen offers a platform for professionals to make a meaningful impact.
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### **Key Responsibilities**
- **Quality Oversight**: Provide quality input for processes relating to observational research studies, including the clinical trial risk assessment (CT-RACT).
- **Vendor Oversight**: Evaluate, qualify, and oversee pharmacovigilance vendors, ensuring compliance with standards and regulations.
- **Compliance and Auditing**: Lead the pharmacovigilance (GPvP) annual audit plan, conduct audits, and investigate quality events. Support inspections and regulatory compliance activities.
- **Continuous Improvement**: Support root cause analysis (RCA) and develop corrective and preventive action (CAPA) plans for process improvements.
- **Risk Management**: Assess and manage risks related to observational research and pharmacovigilance, and contribute to risk-based audit planning.
- **Reporting and Metrics**: Prepare and communicate compliance metrics, including audit and inspection data.
- **Collaboration**: Work closely with internal stakeholders and external partners to maintain and improve compliance practices.
---
### **Qualifications**
- **Education**: Degree educated in a related field.
- **Experience**: Proven experience in R&D, operations, or quality within the pharma/biotech sector.
- **Leadership**: Demonstrated leadership expertise in developing teams and managing projects, with a focus on resource allocation.
- **Auditing Experience**: Experience in auditing, preferably in Good Pharmacovigilance Practice (GPvP) or Good Clinical Practice (GCP), and knowledge of global regulatory requirements.
- **Technical Skills**: Some knowledge of statistical programming (e.g., STATA, SAS) and computer systems audits.
- **Communication**: Excellent oral and written communication skills, with the ability to manage competing priorities effectively.
- **Time Management**: Strong organizational skills and the ability to handle multiple tasks and deadlines.
---
### **What You Can Expect**
- **Location Flexibility**: Work remotely or from our Uxbridge or Cambridge offices with occasional office presence.
- **Growth and Development**: Amgen supports your professional growth and well-being through a generous rewards plan and a collaborative environment.
- **Inclusive Culture**: Join a diverse, inclusive community where your contributions matter, and new ideas are encouraged.
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Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Rangpo |Tamil Nadu :
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Birmingham |Alaska :
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Tuscaloosa |Arizona :
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Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Wilmington |Florida :
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Boise |Illinois :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
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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 | New Brunswick | Newark | 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 | West Orange | Westfield | Wharton | Whippany |New Mexico :
Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Mexico |South Carolina :
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Dalian |Republic of China :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Cairo |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
Harlow | Stevenage | Salt Lake City | Stirling | England | Leeds | London | United Kingdom | Maidenhead |Estonia :
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Surabaya |Jakarta :
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Yavne | Tel Aviv | Be'Er Sheva | Netanya | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
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Almaty |Remote Korea :
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Warsaw |Remote :
Remote, USA | Remote - Africa | Remote - Europe | Remote - Middle East | Remote | Switzerland | Remote - South America (Latin Americal) |Bucharest :
Bucharest |Makkah :
Jeddah | Khulais | Rabigh | King Abdullah Economic City | Riyadh | Najran |Nišava District :
Niš |Singapore :
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Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
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