· Ensures effective functioning of PV projects in compliance with client agreements and applicable regulations and guidelines. · Have ownership of assigned projects and tasks and ensure adherence to timelines and quality. · Management of quality, compliance and documentation across PV projects. · Manage and monitor workload of department / function and alert the functional head / designate in the event of concerns or issues regarding personnel management that may affect the quality and functioning of the work. · Line management for assigned personnel. · Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulation and guidance’s. · Train and mentor personnel, as needed. · Identify new training and development requirements, relevant to the function. · Respond to / represent department / function during audits and inspections · Author and review SOPs and other documents relevant for department/ function. · Other responsibilities as assigned by the Management.
About the Role: We are seeking a dynamic and experienced Director of Medical Information Call Center to lead our global operations supporting medical inquiries, adverse event capturing, and product complaint intake. The ideal candidate will bring a strong background in medical affairs, pharmacovigilance, and contact center leadership, along with a passion for driving compliance, service excellence, and team performance in a Highly regulated environment. Strategy & Leadership • Oversee strategic and operational management of a 24/7 medical information contact center. • Develop and execute SOPs, workflows, and staffing models to ensure timely, accurate responses to healthcare professionals, patients, and clients. • Lead cross-functional teams across medical affairs, regulatory, pharmacovigilance, and quality. • Handle medical information calls, including complex, sensitive, or escalated queries from healthcare professionals, patients, or caregivers. Quality & Compliance • Ensure adherence to global regulatory standards (e.g., FDA, EMA, MHRA, ICH) for medical information, safety, and product complaint handling. • Supervise the creation, review, and approval of Standard Response Documents (SRDs) and FAQs. • Coordinate audits and inspections; implement corrective and preventive actions (CAPAs). Technology & Operations • Manage systems for case intake, triage, documentation, and reporting • Use data dashboards and analytics to monitor KPIs (response time, call resolution, quality scores). • Oversee vendor partnerships and technology integrations to streamline operations and enhance user experience. People & Culture • Recruit, train, and lead a team of medical professionals and multilingual call center agents. • Foster a culture of accountability, empathy, compliance, and continuous learning. • Provide performance coaching, team development, and succession planning. Qualifications Required: • Advanced degree in Life Sciences, Pharmacy, Nursing, Medicine, or equivalent (e.g., PharmD, MD, RN, PhD). • 10+ years’ experience in medical information, pharmacovigilance, or clinical operations. • At least 5 years in a leadership role managing call center teams or outsourced service providers. • In-depth knowledge of regulatory requirements for medical communication and safety reporting. • Experience with safety databases and medical information systems. • Strong project management and cross-functional leadership skills. Preferred: • Previous experience overseeing global or multilingual operations. • Certification in project management, quality, or pharmacovigilance (e.g., PMP, ISO, BPS). • Familiarity with AI/NLP or chatbot integrations in healthcare customer service. • Multilingual abilities or experience leading language-diverse teams.