Director, Medical Safety - Sponsor-Dedicated (Home-based)

About the role

IQVIA is recruiting a Director, Medical Safety for a sponsor-dedicated, home-based position. The role provides global medical safety and pharmacovigilance oversight across clinical development and post-marketing programs, leads medical review of safety data, and manages medical safety projects and teams.

Key responsibilities

• Lead medical review of clinical trial and post-marketing safety data, including adverse events, adverse drug reactions, coding, causality, expectedness, seriousness and benefit-risk assessments.
• Review safety documentation such as narratives, aggregate reports, annual and periodic safety reports, risk management plans, regulatory submissions, labeling, protocols, investigator brochures and case report forms.
• Support safety governance, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight and 24-hour medical support as required.
• Serve as Global Safety Physician, project lead or medical safety advisor, ensuring quality, compliance, operational delivery, training, stakeholder communication and timely completion.
• Present safety findings and give expert medical advice to clients, internal teams and cross-functional stakeholders.
• Lead and develop medical safety teams of physicians and medical safety professionals globally, covering people management, workload planning, performance management, mentoring, training, resource allocation and succession planning.
• Oversee financial, operational and quality performance of projects and contribute to business development, proposals, budgeting, bid defenses, client presentations and service-line growth.
• Represent the Medical Safety function internally and externally, drive continuous improvement and undertake special projects as required.

Required profile

• Medical degree (MD or equivalent) from an accredited institution, with substantial clinical practice experience and/or pharmaceutical physician experience.
• Current medical licensure (or equivalent professional registration) in the country of practice.
• Significant experience in medical safety, pharmacovigilance or medical monitoring within the pharmaceutical, biotechnology, CRO or healthcare industry.
• Proven ability to manage multiple priorities, meet deadlines and deliver high-quality outcomes in a complex environment.
• Demonstrated leadership, including people management, project oversight, financial accountability and strategic decision-making.

Required skills

• Strong knowledge of global pharmacovigilance, clinical research, safety reporting, GCP and applicable regulatory requirements.
• In-depth understanding of clinical development, pharmaceutical research and medical safety/monitoring activities.
• Consulting, communication, stakeholder management and relationship-building skills.