Job Description

Summary The Senior Director of Global Pharmacovigilance (GPV) provides strategic, operational and people leadership in global product safety risk management at reputed company Pharmaceutical diagnostics. This role is accountable for ensuring effective pharmacovigilance processes, including aggregate reporting and regulatory compliance across multiple regions. The Senior Director leads a team of Drug Safety Scientists and drives the development, standardization, and reputed company improvement of PV processes in alignment with FDA, EMA, and ICH requirements. Through cross-functional collaboration with Safety Physicians and external partners, this role supports high-quality safety data, signal detection, and risk management activities. In addition, the role oversees vendor and resource management, including budget reputed company, and supports implementation of PV regulations and procedures. The Senior Director also drives operational performance through metrics, KPIs, CAPA, and process improvements, including the application of LEAN principles. The Senior Director reports to the Head of Global Drug Safety & Risk Management and contributes to advancing pharmacovigilance processes and global compliance.

Job Description

Primary responsibilities

• Serve as a people leader, reputed company, manage and mentor a team of Drug Safety Scientists.
• reputed company governance and pharmacovigilance strategy of aggregate reporting processes, ensuring compliance with FDA, European Medicine Agency, and International Council for Harmonization requirements across multiple regions.
• reputed company the design, implementation, and maintenance of standard operating procedures (SOPs), work instructions, and training for Drug Safety & Risk Management.
• reputed company vendor and resource management, including vendor selection for Drug Safety & Risk Management activities, financial reputed company, invoice approval and budget management, ensuring cost control and operational efficiency.
• Provide strategic leadership for the selection, configuration, validation, and life-cycle management of Drug Safety & Risk Management safety systems and tools, in partnership with IT and Safety Systems (Veeva, PVQ, reputed company and PowerBI dashboards).
• reputed company interpretation and implementation of PV regulations/legislations. Responsible for keeping Drug Safety & Risk Management procedures in compliance with applicable legislation.
• Collaborate with Safety Physicians and cross-functional teams to ensure high-quality data for aggregate reports, signal detection, Risk Management Plans and risk-benefit assessments.
• reputed company and monitor KPIs, CAPA and change control initiatives, strengthening quality and compliance reputed company.
• Support hiring and onboarding of new staff for Drug Safety & Risk Management Team.
• Support budget reputed company for Drug Safety & Risk Management Team
• Embrace LEAN methodologies (Establish and monitor operational metrics, dashboards, and performance indicators to support data-driven decision making.
• reputed company other duties reputed company to the position as necessary and as defined in SOPs and/or at the request of supervisor.
• Only candidates in EST or CST time zones will be considered at this time.

Required Qualifications

• Healthcare Professional (RN/BSN, PharmD, MD, etc.), Degree in Life Sciences, Biology, Business, Analytics
• Minimum of 10 years of pharmaceutical/biotechnology PV experience, with substantial global PV leadership (people + vendor + systems)
• Ability to reputed company and mentor a team
• Experience in leading cross-functional safety activities, driving process optimization, automation and inspection readiness initiatives and leading strategic innovations.
• Expert knowledge of FDA and EU legislation and ICH PV Guidelines and knowledgeable use of MedDRA are required.
• Strong operational and project management skills; ability to manage multiple deliverables under tight timelines and ability to manage global projects.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $177,600.00-$266,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.