What are the responsibilities and job description for the Pharmacovigilance (PV) Business Analyst / SME position at HPTech Inc.?
Job Details
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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