Overview:
Alphanumeric is seeking an experienced Pharmacovigilance Manager (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: 9-months 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 salary
Key Responsibilities:
- Provides oversight for 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.
- Ensure that third parties/vendors develop and implement robust processes to support quality-driven organization and in agreement with ICSR Management Team written standards.
- Build external relationships with key stakeholders and senior leaders.
- Provides support and guidance to the ICSR Management Leads and team members to ensure compliance with global regulations, adherence to the client´s SOPs and all ICSR Management Team written standards.
- Resolve issues and concerns within the ICSR Management team and escalate to ICSR. Management Director, where resolution is not possible or there is impact across PV Ops.
- Identify training requirements and work with training team to establish required training plan for individuals as required.
- Provide strategic advice to the ICSR Management Director team in regards to written. standards, processes and procedures.
- Mentor new staff during onboarding.
- Use influencing skills to drive best practice and innovation across PV Ops.
- Enhance matrix management across PV Ops, ensuring successful connections with PV Ops sub teams.
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.