Associate Director / Director - Regional Pharmacovigilance Leader (Americas)

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 working with other regional PV leaders to ensure consistency and cross-application of learnings when appropriate. The role leads a team of affiliate-level pharmacovigilance professionals, drives cross-functional integration of pharmacovigilance capabilities, and represents the region in GPS-level governance and strategy. Holding a Local QPPV / responsible person nomination is not a core expectation of this role.

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 consistency, quality, compliance, and continuous improvement of pharmacovigilance operations across all affiliates within the region; Serve as the primary link between regional affiliate safety personnel, Global Patient Safety (GPS), QPPVs, and the Medical Quality Organization (MQO); 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 GPS and regional affiliate safety personnel; Oversee regional quality oversight, CAPAs and vendor performance; Run the regional QPPV and Local Responsible Person network; Oversee interactions with Ministries of Health and national regulatory authorities on pharmacovigilance matters; Build a culture of inspection readiness and support affiliate inspections and audits; 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; Experience 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; 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

Excellent communication (written and verbal), interpersonal, organizational and negotiation skills; Professional knowledge of English including medical terminology; Demonstrated expertise in the interpretation and application of international regulations related to drug, device safety reporting and strong knowledge of quality systems; Cross-functional networking, relationship development and management; Demonstrated experience managing pharmacovigilance operations across multiple countries with differing regulatory regimes, languages and business models; Decision making and prioritization; Demonstrated ability to innovate and drive successful transformational change; Ability to travel as needed (~20%); Experience holding, deputizing for, or directly overseeing a Local QPPV or nationally designated responsible person position

Benefits

Company bonus (depending, in part, on company and individual performance); Company-sponsored 401(k); Pension; Vacation benefits; Medical, dental, vision and prescription drug benefits; Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); Life insurance and death benefits; Certain time off and leave of absence benefits; Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)