Pharmacovigilance Sr. Business Analyst/SME - Contract Role

Responsibilities

1. Collaborate with cross-functional teams to ensure seamless integration of business and technical requirements.
2. Provide expert guidance on pharmacovigilance best practices.
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.
4. Detail-oriented with strong analytical skills.
5. Ability to work independently and as part of a team.
6. Strong problem-solving and decision-making abilities.
7. Proactive and adaptable to changing environments.