Pharmacovigilance Sr. Business Analyst / SME Job at LABINE AND ASSOCIATES, INC., Collegeville, PA

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  • LABINE AND ASSOCIATES, INC.
  • Collegeville, PA

Job Description

Responsibilities:

  • Collaborate with cross-functional teams to ensure seamless integration of business and technical requirements.
  • Provide expert guidance on pharmacovigilance best practices and
  • Ability to rapidly analysis and understand current process by reading sops and documentation and getting familiar with client business language
  • Conduct training sessions for team members on case processing and pharmacovigilance systems.
Requirements:
  • Bachelor's degree in Life Sciences, Pharmacy, or related field.
  • Minimum of 10-15 years of experience in pharmacovigilance case processing and business analysis
  • Strong business analysis skills with the ability to understand and document business process and requirements.
  • Experience in working with ARGUS processing system is a must
  • Excellent communication skills, both written and verbal.
  • Proven ability to bridge the gap between business requirements and technical systems.
  • In-depth knowledge of pharmacovigilance regulations and guidelines, including FDA and EMA regulations.
  • Proficiency in medical coding with MedDRA and understanding of the WHO Drug Dictionary.
  • Experience working in a pharmacovigilance as a case processor is a plus
Preferred Qualifications:
  • Advanced degree (Master's or PhD) in a relevant field.
  • Experience with global pharmacovigilance operations.
  • Certification in pharmacovigilance or related areas.

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