Pharmacovigilance Senior Specialist (SME) / Remote (based in India) / 1-year contract

Overview: Alphanumeric is seeking a Pharmacovigilance Senior Specialist (100% remote) based in India for project-based contract work. This project is for one of the biggest pharmaceutical brands in the world. Job Purpose: The key purpose of this role is to support Pharmacovigilance Operations “PV Ops”– ICSR Management. Job conditions: Start date: as soon as possible Type of contract: 12-month temporary contract (with possibility of extension). Location: 100% remote in India. Notice that the leadership team is based in London. Working shift: business hours in London - some flexibility is well appreciated thanks to the global nature of our company. Competitive salary Key Responsibilities: • Contribute to creation, maintenance, and archiving of written standards for ICSR Management Team. • Work across a complex matrix environment to drive high-quality documentation of all processes and procedures to comply with internal standards and external regulatory requirements; where problems or issues are identified, assist in facilitating investigation into root cause and create corrective/preventative actions (CAPAs). • Escalate identified problems or issues to the appropriate Management Personnel with PV Operations. • Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes. • Work with third parties/vendors to assist in development and implementation of robust processes to support quality-driven organization and in agreement with ICSR Management Team written standards. • Support Technical Associates with enhancement of knowledge and skills for ICSR Management activities. • Acts as a global PV Operations subject matter expert for process discussions, including queries on strategy/policy related decisions; authors or provides significant input into the development of written standards. • Generates new ideas and proposals for global implementation; contributes to advancement of ICSR management • Prioritize work and time management, in line with business needs Education Requirements: Degree in life sciences or medically related field or previous experience equating to educational requirements. Job Related Experience: • Process development and maintenance of written standards, e.g. SOPs, Work Instructions, Job Aids, How To Guides, etc. • Ability to map processes and author written standards. • Knowledge and experience with pharmacovigilance systems. Apply Job!