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.
