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Pharmacovigilance - Business Analyst

Cygnus Professionals Inc.
Collegeville, PA Full Time
POSTED ON 2/5/2025
AVAILABLE BEFORE 3/6/2025

Title: Pharmacovigilance Sr. Business Analyst / SME

Location: College Ville, PA (Onsite Role)

Employment Type: Full Time Role


Complete JD

Responsibilities:

1 Collaborate with cross-functional teams to ensure seamless integration of business and technical requirements.

2 Provide expert guidance on pharmacovigilance best practices and 

3 Ability to rapidly analysis and understand current process by reading sops and documentation and getting familiar with client business language 

4 Conduct training sessions for team members on case processing and pharmacovigilance systems.

Requirements:

1 Bachelor’s degree in Life Sciences, Pharmacy, or related field.

2 Minimum of 10-15 years of experience in pharmacovigilance case processing and business analysis 

3 Strong business analysis skills with the ability to understand and document business process and requirements.

4 Experience in working with ARGUS processing system is a must

5 Excellent communication skills, both written and verbal.

6 Proven ability to bridge the gap between business requirements and technical systems.

7 In-depth knowledge of pharmacovigilance regulations and guidelines, including FDA and EMA regulations.

8 Proficiency in medical coding with MedDRA and understanding of the WHO Drug Dictionary.

9 Experience working in a pharmacovigilance as a case processor is a plus 

Preferred Qualifications:

1 Advanced degree (Master’s or PhD) in a relevant field.

2 Experience with global pharmacovigilance operations.

3 Certification in pharmacovigilance or related areas.

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