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.