The Associate Safety Data Management Specialist processes Individual Case Safety Reports, validates cases, and ensures compliance with pharmacovigilance regulations.
In this pharmacovigilance role, you will carry out processing activities of Individual Case Safety Reports (both clinical trials and post-marketing sources) in the ARGUS Safety database.
Processing activities include assessing case validity, undertaking duplicate checks, creating cases in the database, prioritizing cases as per company guidance, updating cases with information provided in XML source documents, identifying adverse events, confirming their seriousness, coding products, undertaking causality and listedness assessments, drafting narratives, determining appropriate case follow-up, reviewing processed cases to verify technical judgment, accuracy, and compliance with company requirements, etc.
Here Is What You Need (Minimum Requirements):
Education = B. Pharm, M. Pharm, or Pharm. D only.
Minimum experience = 1 year. Maximum = 2 years.
End-to-end ICSR processing, including labeling assessments.
Good knowledge of medical terminology and global regulatory requirements for drug safety.
Keen attention to detail.
Solid analytical skills.
Good written and oral communication skills.
Collaborative skills.
Continuous Learning.
Bonus Points If You Have (Preferred Requirements):
Hands-on experience in the ARGUS safety database.
Proficiency with processing source documents in XML format (E2B R2 and R3).
Course completion and/or certification in Pharmacovigilance.
Publications in peer reviewed journals.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE
Processing activities include assessing case validity, undertaking duplicate checks, creating cases in the database, prioritizing cases as per company guidance, updating cases with information provided in XML source documents, identifying adverse events, confirming their seriousness, coding products, undertaking causality and listedness assessments, drafting narratives, determining appropriate case follow-up, reviewing processed cases to verify technical judgment, accuracy, and compliance with company requirements, etc.
Here Is What You Need (Minimum Requirements):
Education = B. Pharm, M. Pharm, or Pharm. D only.
Minimum experience = 1 year. Maximum = 2 years.
End-to-end ICSR processing, including labeling assessments.
Good knowledge of medical terminology and global regulatory requirements for drug safety.
Keen attention to detail.
Solid analytical skills.
Good written and oral communication skills.
Collaborative skills.
Continuous Learning.
Bonus Points If You Have (Preferred Requirements):
Hands-on experience in the ARGUS safety database.
Proficiency with processing source documents in XML format (E2B R2 and R3).
Course completion and/or certification in Pharmacovigilance.
Publications in peer reviewed journals.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE
Top Skills
Argus Safety
XML
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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