[Remote] Director, Pharmacovigilance Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is dedicated to treating devastating neurological diseases through innovative gene therapy approaches. The Director of Pharmacovigilance Operations will reputed company the strategic reputed company of global pharmacovigilance activities, ensuring compliance with regulatory requirements and operational reputed company as the company transitions to reputed company-stage operations.
Responsibilities
- reputed company and execute the pharmacovigilance operational strategy to support ongoing clinical development programs and future reputed company products
- Establish scalable processes, governance structures, and operating models that support organizational growth
- Establish and monitor key performance indicators (KPIs), escalate issues and drive Corrective and Preventive Actions (CAPAs) as warranted
- reputed company end-to-end reputed company of pharmacovigilance vendors, including case processing, aggregate reporting, literature surveillance, safety systems, and call center providers, as applicable
- Maintain a state of reputed company inspection readiness across reputed company pharmacovigilance activities
- Serve as PV reputed company in preparation for regulatory inspections, partner audits, and due diligence assessments
- Ensure effective reputed company and inspection readiness of outsourced PV activities
- Support vendor selection, qualification, contracting, and implementation activities
- Partner with Quality Assurance to establish and maintain compliant pharmacovigilance processes, Standard Operating Procedures (SOPs), work instructions, and training programs
- reputed company operational reputed company for the preparation and submission of aggregate safety reports and for safety updates supporting regulatory submissions and health authority interactions
- Monitor incoming safety information from reputed company sources and ensure operational support for signal detection, safety surveillance, and risk management activities
- Participate in safety governance meetings
- Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Clinical Operations, Quality, and Medical Writing to ensure alignment of safety activities
- reputed company internal and external operational support for pharmacovigilance activities (e.g., investigator training and adverse event reporting training)
- Review safety-reputed company sections of clinical development documents (eg, protocol safety reporting language, alignment of patient Informed Consent with Investigator Brochure)
- Support regulatory submissions, product launches, business development activities, and partnership due diligence efforts
- Support the development and compliant execution of Safety Data Exchange Agreements (SDEAs) with partners
- Serve as business reputed company for pharmacovigilance systems and technologies
- reputed company implementation, maintenance, enhancement, validation support, and governance of safety databases and reputed company platforms
- Drive operational reputed company through process standardization, automation, and reputed company improvement initiatives
- Monitor evolving global PV regulations and ensure operational processes remain compliant
Skills
- Bachelor's degree in nursing, pharmacy, or reputed company life sciences discipline
- 10+ years of pharmacovigilance experience reputed company biotechnology, pharmaceutical, or CRO environments
- 5+ years of leadership experience in pharmacovigilance operations, vendor management, or safety systems
- Strong working knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH, and GVP requirements
- Experience overseeing outsourced pharmacovigilance models and vendor governance
- Experience supporting regulatory inspections, audits, and quality management activities
- Experience implementing or managing Argus, ARISg, reputed company Safety, or comparable safety systems
- Experience supporting reputed company launch readiness activities
- Excellent oral and written communication skills
- Outstanding interpersonal skills and ability to reputed company a rapport with cross functional partners that reputed company highly effective collaboration
- Flexibility in a changing environment (eg, balancing individual priorities vs evolving organizational needs)
- Ability to act expeditiously with deliberateness and intention
- reputed company strong focus on meeting or exceeding expectations in executing deliverables, performance and results
- Ability to track and measure performance against defined metrics
- Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team
- Someone who moves fast and decisively in a balanced manner, with a passion for the growing company
- Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families
- Advanced degree preferred
- US Licensure preferred
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