Pharmacovigilance Team Leader (100 % remote, based in the UK)
Alphanumeric is seeking a Pharmacovigilance Team Leader (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:
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.
Please 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 all aspects of 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 Scientists with enhancement of knowledge and skills for ICSR Management activities.
* Acts as a global PV Operations Leader 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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