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Alphanumeric is hiring an experienced Pharmacovigilance Principal Scientist for a 100% remote, India-based project contract supporting one of the world’s leading pharmaceutical companies. This senior PV role focuses on PV management systems, ICSR governance, SOP development, CAPA, audit readiness, and global compliance.
This opportunity is ideal for professionals with strong expertise in pharmacovigilance operations, regulatory guidelines, safety systems, and quality-driven PV processes who are seeking high-impact remote roles.
🔍 Key Responsibilities
As a Pharmacovigilance Principal Scientist, you will:
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- Lead ICSR Management Team written standards (SOPs, WIs, Job Aids, Process Maps)
- Act as a global PV Operations SME for strategy, policy, and process decisions
- Support and mentor PV Scientists on ICSR processing, regulatory submissions, and oversight
- Author and investigate deviations, RCA, CAPA, and audit findings
- Drive quality issue management, root cause investigations, and preventive actions
- Support audit and inspection readiness for health authorities and partners
- Collaborate with third-party PV vendors and service providers
- Generate metrics, trend analyses, and management presentations
- Ensure data integrity and compliance across PV systems and documentation platforms
- Recommend and implement process improvements to prevent repeat findings
- Manage cross-functional deliverables in a global matrix environment
🎓 Qualifications & Experience
Education
- Degree in Life Sciences, Pharmacy, Medicine, or related field
- Equivalent professional PV experience may be considered
Experience Required
- Strong hands-on experience in PV SOPs, WIs, Job Aids, and process governance
- Proven expertise in CAPA, RCA, deviation management, and audit follow-ups
- In-depth knowledge of global PV regulations (ICH, GVP Modules, FDA)
- Experience with PV safety databases: Argus, ArisGlobal, Veeva Vault Safety
- Ability to map complex PV processes and translate them into compliant documentation
- Experience supporting health authority inspections and vendor oversight
- Excellent written and verbal communication with global stakeholders
💼 Why Join This Role?
- 🌍 100% Remote – Work from anywhere in India
- 🧠 Senior-level Pharmacovigilance leadership exposure
- 🏆 Work on projects for a top global pharmaceutical brand
- 📈 Enhance expertise in global PV governance & compliance
- 🤝 Collaborative, quality-driven international work environment
📝 How to Apply
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