Pharmacovigilance Principal Scientist - 100% remote from India

Degree in life sciences or medical related field or equivalent experience. Hands-on experience in process development, optimization, and governance of PV written standards (SOPs, WIs, Job Aids, Process Maps, How-To Guides). Experience and strong understanding of CAPA, RCA, and structured follow-up action plans. Ability to map complex PV processes, translate operational requirements into clear documentation, and manage updates through formal quality systems. Practical knowledge of global pharmacovigilance regulatory guidelines (e.g., ICH, GVP Modules, FDA regulations). Experience working within safety databases or PV systems (e.g., Argus, ArisGlobal, Veeva Vault Safety). Experience in operational risk assessment, quality issue management, CAPA creation, and health authority/partner audit preparation is preferred. Strong written and verbal communication skills. Ability to collaborate across global teams. Ability to influence decision-making. Ability to support a culture of quality and compliance. Process development and maintenance of written standards. Ability to map processes and author written standards. Knowledge and experience with pharmacovigilance systems.

Contribute to creation, maintenance, and written standards for ICSR Management Team. Act as a global PV Operations Leader for process discussions. Support PV Scientists with knowledge enhancement for ICSR Management. Work across a complex matrix environment to drive high-quality documentation. Identify and facilitate investigation into root cause and create CAPAs. Investigate and author deviations from established written procedures. Author investigations, RCA, CAPA for non-conformances from audit findings. Support trending analysis with third party service provider and client. Provide metrics for presentations. Recommend process changes to avoid repeat findings. Escalate identified problems or issues. Generate new ideas and proposals for global implementation. Work with third parties/vendors to implement robust processes. Prioritize work and time management. Partner with third parties and PV service providers/vendors to design and monitor processes. Assist in inspection and audit readiness activities. Support data integrity initiatives. Manage workload and priorities effectively.