Overview:Alphanumeric is seeking a Pharmacovigilance Senior Specialist (100% remote) based in the UK 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: ASAP.Type of contract: 9-month temporary contract (with possibility of extension).Location: 100% remote in the UK as per client request.
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 salaryPlease note that we cannot offer work visa sponsorships for this role.
In the case of non-resident candidates, we will ask for proof of eligibility to work in the UK.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 managementPrioritize work and time management, in line with business needsEducation 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.