Job Overview:
We are seeking a highly skilled and detail-oriented Submission Expert specializing in Individual Case Safety Reports (ICSR) to join our Pharmacovigilance team. The Submission Expert will play a critical role in ensuring the timely and accurate submission of ICSR to regulatory authorities in compliance with global pharmacovigilance regulations and guidelines.
Key Responsibilities:
CSR Submission Management: - Oversee the end-to-end process of ICSR submission to regulatory authorities, including but not limited to FDA, EMA, and other global health agencies. - Ensure that all submissions are completed within established timelines and by regulatory requirements.
2. Regulatory Compliance: - Stay updated on global pharmacovigilance regulations, guidelines, and requirements related to ICSR submissions. - Ensure compliance with regulatory standards and guidelines in all aspects of ICSR submission activities.
3. Quality Assurance: - Implement quality control measures to ensure the accuracy, completeness, and consistency of ICSR submissions. - Conduct periodic audits and reviews to identify and address any discrepancies or deficiencies in the submission process and reporting rules Configuration of Product and license
4. Documentation and Record-Keeping: Maintain comprehensive documentation of all ICSR submission activities, including correspondence with regulatory authorities, submission records, and related documentation. - Ensure the accuracy and completeness of submission documentation for audit and inspection readiness.
Qualifications and Requirements:
1. Bachelor's degree in pharmacy, life sciences, or related field; advanced degree preferred.
2. Minimum of 5 years of experience in pharmacovigilance, with a focus on ICSR submission activities.
3. In-depth knowledge of global pharmacovigilance regulations and guidelines, including ICH E2B standards.
Experience with pharmacovigilance databases and submission systems (e.g., EudraVigilance, FAERS). - Strong attention to detail and accuracy, with the ability to manage multiple priorities in a fast-paced environment. - Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams. - Proficiency in relevant software applications, including Microsoft Office suite and pharmacovigilance software platforms.
Preferred Skills:- Experience with regulatory submissions in multiple regions (e.g., US, EU, Japan) is highly desirable. - Familiarity with safety data exchange agreements (SDEAs) and risk management plans (RMPs) is an asset.
Join Our Team: If you are a dedicated professional with a passion for pharmacovigilance and a commitment to ensuring the safety of patients worldwide, we invite you to apply for the Submission Expert - ICSR position. Join us in our mission to advance healthcare through innovation and excellence in pharmacovigilance.
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Ranchi |Karnataka :
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Punjab :
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Atlanta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Garden city | Lawrence |Kenlucky :
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Frank Scottile Blvd |LA :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Eden Prairie | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
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Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
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New Hampshire |Ohio :
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Memphis | Nashville |Texas :
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Madison | Wausau |Wisconsin :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Bulgaria |Denmark :
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Latvia | Leuven | Poland | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |China :
China |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Cork :
Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Republic of Ireland :
Dublin | Limerick | Waterford |Ulster :
Donegal |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |South Holland :
Leiden |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
North York | Uxbridge | Richmond Hill | Mississauga |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |South Yorkshire :
Sheffield |United Kingdom :
United Kingdom | Stirling | Maidenhead | London | Harlow | Salt Lake City | Leeds |Estonia :
Tartu | Estonia |Harju County (Maakond) :
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North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Tel Aviv | Netanya | Be'Er Sheva |Italy :
Italy |Lombardy :
Rho |Japan :
Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Remote, USA | Switzerland | Remote - Europe | Remote - Middle East | Remote |Bucharest :
Bucharest |Makkah :
Khulais | Riyadh | Rabigh | Jeddah | Najran |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand |Brazil :
Sao paulo |South America :
Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |