Director, Pharmacovigilance Vendor Management


Job Description

The purpose of this position is to support Alcon management to develop, communicate and implement External Service Provider (ESP) strategies and key pharmacoviligance priorities. This position is also responsible for ESP performance (quality, compliance and productivity) and site audit / inspection management in collaboration with Alcon Medical Safety and QA functional teams.

Major Accountabilities:
• Efficiently manage pharmacovigilance activities outsourced to ESP including all operational aspects (contractual, day-to-day operations, financial performance, metrics, and forecasting).
• Responsible for managing financial requirements and budget for assigned ESP.
• Identifies issues and proposes mitigating plans to facilitate decision-making and prioritization.
• Responsible for ESP governance meetings, issues / escalation management and tracking.
• Responsible for transition of activities to ESP and adherence to standard operating procedures.
• Supports implementation of ESP performance management tools and systems in consultation with different stakeholders including R&D, QA, IT, Procurement and Finance.
• Conducts periodic monitoring of outsourced activities and ensures contractual commitments are met consistently.
• Supports functional heads from Medical Safety and QA to drive quality, compliance and productivity at ESP sites.
• Facilitates and manages effective communication at leadership levels between Alcon and ESPs to ensure business integrity.
• Acts as a liaison for exchange of ideas / proposals / target assignments to achieve highest efficiency, productivity and compliance for all outsourced activities.
• Supports ESPs during audits and inspections for logistics, documentation, CAPAs and closure of finding (if any); alerts Alcon management of pending compliance issues as well as audit and inspection findings at ESP sites.

Key Performance Indicators:
• Effective management (in accordance with contracts) of assigned ESPs
• Timely reporting of potential issues to Alcon and ESP management (as appropriate)
• Adherence to performance and financial targets for defined ESP functions
• Feedback to internal and ESP stakeholders for continuous improvements

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Minimum requirements

• Bachelor's Degree or Equivalent years of directly related experience (HS +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
• The ability to fluently read, write, understand and communicate in English
• 10 Years of Relevant Experience, preferably in pharmacovigilance, knowledge of drug safety regulatory requirements and/or general project management as well as third party management experience
• Demonstrated success in project planning, resource management, and implementation of strategies
• Strong interpersonal skills and experience working with cross-functional and diverse teams
• Excellent communication skills, presentation skills and computer skills (MS Office)
• Excellent negotiation, conflict resolution, decision-making and problem-solving skills


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