Job Summary
Fortrea, a leading global Contract Research Organization (CRO), seeks an experienced Associate Manager, Process Compliance, Review and Analysis to manage the quality of pharmacovigilance deliverables, including adverse event reports, product quality complaints, and medical information. The role demands expertise in Good Pharmacovigilance Practices (GVP), FDA/EU guidelines, and process optimization, ensuring accurate and compliant submissions to regulatory agencies and clients. Ideal for professionals with over five years of PV or safety writing experience and a strong background in quality assurance.
Key Responsibilities
Ensure quality deliverables and process implementation with minimal supervision.
Serve as the primary point of contact for delivery teams regarding regulatory updates, quality procedures, and best practices.
Analyze quality findings and develop corrective action plans.
Address client quality reviews, feedback, and audits for ongoing projects.
Conduct quality reviews on safety reports, regulatory documents (e.g., PSURs, PADERs, USPI), and clinical documents.
Oversee case processing quality, ensuring regulatory compliance.
Track, publish, and analyze quality metrics; drive process improvements.
Prepare for and support client audits and regulatory inspections.
Lead development, review, and training on SOPs, Work Instructions, and conventions.
Design training schedules and conduct skill-gap analyses based on quality findings.
Provide guidance on handling medical information queries and product complaints.
Support Computer System Validation activities and continuous process improvement initiatives.
Required Skills & Qualifications
Bachelor’s/Master’s/PhD in Medicine, Pharmaceutical Sciences, Life Sciences, Nursing, or related fields.
Minimum 5 years in the pharmaceutical/CRO industry, including 2 years in PV quality review or peer review.
Strong knowledge of GVP, FDA, EU guidelines, and pharmacovigilance operations.
Proficiency in Microsoft Office Suite.
Understanding of lean methodologies.
Preferred: experience with CAPA management, trend analysis, and safety case documentation quality assessment.
Perks & Benefits
Hybrid work flexibility (office or remote as needed).
Opportunity to influence quality standards in global pharmacovigilance.
Cross-functional exposure to regulatory, safety, and process improvement teams.
Professional development in global drug safety and regulatory affairs.
Access to cutting-edge CRO processes and training resources.
Company Description
Fortrea is a top global Contract Research Organization (CRO) delivering clinical development and technology solutions to pharmaceutical, biotechnology, and medical device industries across 20+ therapeutic areas. Operating in over 100 countries, Fortrea drives innovation in drug and device development while prioritizing patient safety and regulatory compliance.
Work Mode
Hybrid (Office/Remote as per project and management needs)
Call-to-Action
Advance your pharmacovigilance and process quality career with a global leader. Apply now to join Fortrea as an Associate Manager – Process Compliance and make a lasting impact on global healthcare.
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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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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 :
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Birmingham |Virginia :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Mississauga | North York | Australia | Richmond Hill | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
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Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Italy |Lombardy :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Najran | Rabigh | Riyadh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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Sweden |Taipei :
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