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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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Australia | North York | Uxbridge | Richmond Hill | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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 :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Rabigh | Najran | King Abdullah Economic City | Jeddah | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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