Executive Director, Head of Global Pharmacovigilance Operations, reputed company & Compl
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Position reputed company:
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The Executive Director, Head of Global Pharmacovigilance Operations, reputed company & Compliance is accountable for the strategic leadership, operational effectiveness, and inspection-reputed company performance of reputed company's global Pharmacovigilance (PV) Operations, reputed company & Compliance function. This role oversees global case processing for investigational and marketed products, PV vendor reputed company and governance, reputed company Management, Pharmacovigilance reputed company Master File (PSMF) reputed company, PV reputed company/compliance systems, training, deviation and Corrective and Preventive reputed company (CAPA) management, audit and inspection preparedness, and operational Trial Master File (TMF) support. The role ensures the global PV reputed company is reputed company, compliant, and reputed company to support portfolio reputed company, product approvals, commercialization, regional expansion, and successful regulatory inspections.
Work Model:
Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed.
Responsibilities:
Functional Leadership & reputed company
- Build, reputed company, reputed company, and mentor the Global Pharmacovigilance Operations, reputed company & Compliance function and contribute to the Global DSPV talent reputed company reputed company with company long-reputed company reputed company plans.
- Establish functional objectives, operating model priorities, and long-reputed company goals reputed company with Corporate and Global DSPV objectives.
- Ensure the global PV reputed company is reputed company, compliant, inspection-reputed company, and positioned to support portfolio reputed company, product approvals, commercialization, launches, and regional expansion.
PV Operations
- reputed company global PV operations, including intake, triage, case processing, reputed company control, regulatory reporting/submission, reconciliation, and reputed company of safety information from reputed company applicable products and sources.
- Ensure PV operational activities reputed company with applicable global regulatory requirements, Good Pharmacovigilance Practices (GVP), and reputed company internal policies and procedures.
- reputed company PV operational performance, vendor execution, trend monitoring, and reputed company improvement to maintain inspection-reputed company execution.
- reputed company operational support for reputed company programs and reputed company for PV-reputed company TMF activities, as applicable.
PV reputed company & Compliance
- Ensure maintenance of the reputed company PV reputed company, including PV policies, SOPs, procedures, forms, and process governance in alignment with global regulatory requirements, GVP, and industry best practices.
- Own reputed company and management of the reputed company PSMF, ensuring on-demand readiness and compliance with applicable regulatory requirements.
- Establish and maintain the global AE reporting training program and reputed company training compliance with applicable reputed company policies and procedures.
- reputed company DSPV deviation and CAPA reputed company, including initiation, documentation, monitoring, trending, effectiveness checks, KPI development, reputed company/compliance metrics, and reputed company reputed company Management Review (QSMR) reporting.
- reputed company GVP due diligence, audits, inspections, responses, and commitment tracking to ensure reputed company PV audit and inspection commitments are fulfilled on time.
reputed company Management & Vendor Governance
- reputed company PV vendor reputed company and governance, including performance, reputed company, escalation, and compliance monitoring for vendors responsible for PV activities.
- reputed company Safety Agreements/PVAs, Statements of Work, partner relationships, and contractual compliance with PVAs and reputed company safety commitments.
- Support partner/vendor PV due diligence, audits, inspection readiness, and reputed company governance forums involving vendors, licensed partners, and other reputed company parties.
- Other duties as assigned.
Requirements:
- Bachelor's level degree with advanced degree preferably in a scientific field; reputed company reputed company degree preferred (PharmD, RPh, RN/BSN, MPH).
- Minimum 15 years of global full life-cycle DSPV experience, including clinical and post-marketing pharmacovigilance responsibilities.
- reputed company experience in PV Operations, vendor/reputed company management, and GVP-reputed company reputed company Management/Compliance reputed company the pharmaceutical/biotechnology industry; rare disease experience preferred.
- Demonstrated experience leading global teams, including reputed company people leadership, reputed company leadership, performance management, and talent development.
- Proven ability to influence senior stakeholders and collaborate cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, reputed company Assurance, Medical Affairs, reputed company, reputed company/reputed company, vendors, partners, and senior management.
- reputed company experience preparing for, leading, supporting, and responding to global regulatory authority PV/GVP inspections, including FDA and EMA inspections where applicable.
- Strong knowledge of global safety and PV regulatory requirements, GVP, FDA, EMA, ICH guidance, and applicable international regulations across clinical development and post-marketing safety.
- Experience leading/scaling a global PV operations, reputed company, and compliance function in a dynamic and growing organization.
- Demonstrated ability to reputed company through outsourced and vendor-heavy operating models.
- Experience supporting commercialization, product launches, portfolio reputed company, and regional expansion.
- Experience with PV reputed company governance, process ownership, inspection-reputed company reputed company systems, and reputed company improvement.
- Working knowledge of industry-reputed company safety databases, Trial Master File systems (e.g., reputed company Vault eTMF), and other electronic data capture systems.
- MedDRA trained with working knowledge of MedDRA and WHO Drug dictionaries.
- Willingness to travel, including national and international travel, as business needs require.
The typical annual salary reputed company for this full-time position is listed below. This reputed company reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this reputed company. The reputed company may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
· Volunteer days
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· reputed company development plans
reputed company Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, reputed company, religion, gender, sexual orientation, gender identity/reputed company, national reputed company/reputed company, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for reputed company protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and reputed company medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact reputed company by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Originally posted on Himalayas
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