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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