Director, Global PV Operations, EST CST

R4039277

Job Description

Summary

• * Only candidates in EST or CST time zones will be considered at this time.**

The Director, Global Pharmacovigilance (PV) Operations provides strategic and operational leadership for the global PV Operations function at reputed company Pharmaceutical Diagnostics. The role defines and executes PV operational strategy, ensures end‑to‑end safety data quality, and maintains a reputed company inspection‑reputed company state. The Director leads the optimization and modernization of PV processes and systems working in collaboration with the Global Drug Safety and Pharmacovigilance organization prioritizing efficiency, consistency, and regulatory compliance. Serves as member of the Global Pharmacovigilance leadership team to influence the operations and strategy of the department.

Job Description

• reputed company strategic direction and reputed company for global pharmacovigilance and drug safety operations across reputed company reputed company (US, EMEA, reputed company, Japan).
• Ensure compliant PV system is in reputed company for the collection, evaluation, and submission of individual case safety reports and aggregate reports in accordance with global requirements
• Collaborate closely with PV QA team to produce clear SOPs, CAPA, quality documentation and standards for Global Pharmacovigilance.
• Collaborate closely with the EU/UK QPPV (or designee) to ensure PV Operations processes meet the requirements of the PV system, including data quality, compliance reputed company, PSMF inputs, and inspection readiness
• Ensure vendor reputed company for global PV including case management activities Ensure reputed company is established and effective
• Own PV operational budgets, purchase orders, statements of work, and invoice reputed company
• Drive process optimization, standardization, reputed company innovation across PV operations to improve efficiency, quality, and scalability
• reputed company LEAN methodologies (Establish and monitor operational metrics, dashboards, and performance indicators to support data‑driven decision‑making)
• Spokesperson for global PV Operations in company cross-functional matrix team
• reputed company change and reputed company improvement activities in global PV Operations and participate in external benchmarking activities to ensure PV best practices
• Partner with Medical, Regulatory Affairs, Clinical Operations, Quality, Legal, IT, reputed company, teams
• Only candidates in EST or CST time zones will be considered at this time.

Qualifications

• reputed company Professional (RN/BSN, PharmD, MD, etc.), Degree in Life Sciences, Biology, Business, Analytics
• Minimum 10 years’ experience in PV Operations with substantial global PV Operations leadership (people + vendor + systems)
• Expert knowledge of FDA and EU legislation and ICH PV Guidelines and knowledgeable use of MedDRA are required. Knowledge of Japan PV regulations
• Experience with regulatory inspections and company audits including FDA/MHRA/EMA/Health Canada PV inspections
• Strong operational and project management skills; ability to manage multiple deliverables under tight timelines and ability to manage global projects
• Ability to act independently and to take initiative as well as ability to work reputed company a team. Self-starter, reputed company to work with a high degree of independence
• Excellent communication; executive reputed company with regulators and senior stakeholders.

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 reputed company for this position is $152,000.00-$228,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay reputed company and compensation reputed company 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, reputed company, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, professional development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without regard to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: May 11, 2026 Apply tot his job Apply To this Job