Associate Director / Director - Regional Pharmacovigilance Leader (META)

The purpose of the Associate Director / Director, Regional Pharmacovigilance role is to provide operational and people leadership across pharmacovigilance activities for the aligned regional hub, translating global pharmacovigilance strategy into consistent execution across the region, and also working with other regional PV leaders to ensure consistency and cross-application of learnings when appropriate. This role is accountable for ensuring consistency, quality, compliance, and continuous improvement of pharmacovigilance operations across all affiliates within the region, serving as the primary link between regional affiliate safety personnel, Global Patient Safety (GPS), Qualified Persons for Pharmacovigilance (QPPVs), and the Medical Quality Organization (MQO).

Responsibilities

Provide operational and people leadership across pharmacovigilance activities for the aligned regional hub; Translate global pharmacovigilance strategy into consistent execution across the region; Lead, develop, and motivate regional pharmacovigilance personnel; Ensure adequate, qualified pharmacovigilance coverage across the region, including Local QPPV / responsible person and deputy positions where legally mandated; Operate and maintain the regional pharmacovigilance system and quality system; Act as the primary interface between Global Patient Safety (GPS) and regional affiliate safety personnel; Run the regional chapter of the QPPV and Local Responsible Person network; Oversee interactions with Ministries of Health and national regulatory authorities on pharmacovigilance matters; Coordinate and ensure inspection and audit readiness; Establish and maintain regional business continuity plans covering all pharmacovigilance activities; Oversee the local performance of pharmacovigilance operations vendors and service providers within the region; Ensure local risk-management deliverables, including country-specific RMPs, are delivered to global standards and national timelines; Act in accordance with privacy policies and related procedures

Requirements

Bachelor's degree (or higher) in pharmacy, a medical degree, life science, or health care/pharmaceutical-related field, or equivalent demonstrated experience; Minimum 5 years of pharmacovigilance experience in the pharmaceutical industry; Demonstrated expertise in the interpretation and application of international regulations related to drug and device safety reporting and strong knowledge of quality systems; Demonstrated ability supervising, managing, and leading teams across multiple affiliates or geographies; Experience building pharmacovigilance capabilities, both internally and externally with a range of partners; Consistently demonstrates strong leadership qualities: effectively communicates cross-functionally, remains flexible, maintains accountability to ensure deliverables/timelines are met, and produces high-quality work on complex problems; Regulatory agency inspection experience; Demonstrated experience managing pharmacovigilance operations across multiple countries with differing regulatory regimes, languages and business models; Where the role holder serves as a Local QPPV / responsible person, or as a nominated deputy, the qualification, experience, residency, language and certification requirements prescribed by the relevant national legislation must also be met, and current evidence of those qualifications maintained

Nice to have

Experience holding, deputizing for, or directly overseeing a Local QPPV or nationally designated responsible person position; Professional knowledge of English including medical terminology; Excellent communication (written and verbal), interpersonal, organizational and negotiation skills; Cross-functional networking, relationship development and management; Decision making and prioritization; Demonstrated ability to innovate and drive successful transformational change; Ability to travel as needed (~20%)