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.

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