Pharmacovigilance Manager - 100% remote, based in India

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: +-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.