Your Mission:Pharmacovigilance Compliance & Quality Oversight- Oversee the pharmacovigilance compliance framework for safety reporting across patient support, pharmacy, and infusion clinic operations, ensuring alignment with agreements, regulations, and internal procedures.
- Lead and maintain a risk-based quality control program for pharmacovigilance intake and reporting, including sampling, review criteria, performance benchmarks, and monitoring.
- Oversee quality reviews of adverse event and product complaint records to ensure timeliness, completeness, accuracy, regulatory compliance, documentation quality, and privacy adherence.
- Monitor compliance metrics, quality trends, deviations, and operational risks, and prepare reports for quality and governance review.
Investigations, Deviations & CAPA Management- Lead investigations into pharmacovigilance deviations, reconciliation discrepancies, procedural non-compliance, and documentation issues using root-cause analysis methodologies.
- Assess the impact of quality issues on patient safety, data integrity, regulatory obligations, and contractual commitments.
- Develop, assign, monitor, and evaluate CAPAs to ensure accountability, timely completion, effectiveness, and escalation of unresolved issues.
- Notify manufacturer partners of reportable deviations and compliance concerns in accordance with contractual requirements and escalate significant risks to quality and pharmacovigilance leadership.
Training, Guidance & Knowledge Management- Oversee the development, review, and maintenance of pharmacovigilance training materials and ensure personnel are qualified before performing safety reporting activities.
- Deliver training, coaching, and awareness sessions to operational, clinical, pharmacy, and cross-functional teams.
- Provide subject matter expertise on pharmacovigilance requirements, agreements, procedures, and quality expectations to PV Associates, Specialists, and stakeholders.
- Communicate changes to reporting requirements, systems, agreements, or procedures through appropriate training and education activities
Process Improvement, Documentation & Change Management- Drive the development, review, and continuous improvement of SOPs, work instructions, templates, job aids, and quality tools to align with current practices, contractual requirements, and regulatory expectations.
- Collaborate with PV Operations, Quality Assurance, Program Management, NavieGo, Coverdale, BioScript Pharmacy, and other stakeholders to implement sustainable process improvements.
- Lead or support continuous improvement, operational excellence, and quality initiatives, ensuring activities are properly scoped, documented, implemented, and evaluated.
- Support change management for new systems, regulatory updates, client requirements, and organizational priorities while promoting quality, accountability, and continuous improvement.
Leadership Responsibilities- Provide clear direction, set measurable goals, and hold team members accountable for performance and results.
- Coach, develop, and support team members through feedback, performance reviews, and career development planning.
- Foster a high-performing, inclusive team culture aligned with company values and business objectives.
- Attend and contribute to QBRs by providing pharmacovigilance insights, updates, and compliance-focused recommendations.
- Demonstrate pharmacovigilance compliance leadership across the organization by supporting adherence to regulatory, contractual, and internal process requirements.
What You Bring to the Table:- Qualifications:
- Education:
- Bachelor's degree in Health Sciences, Life Sciences, Nursing, Pharmacy, or a related field required.
- Additional certifications in Pharmacovigilance, Quality Management, or Regulatory Affairs are considered an asset.
- Experience:
- Minimum 5 years of experience in pharmacovigilance, adverse event reporting, safety case management, medical information, or a related healthcare field.
- Experience within a Patient Support Program (PSP), specialty pharmacy, infusion clinic, or other regulated healthcare environment preferred.
- Experience in quality, compliance, operational oversight, or team leadership within a pharmacovigilance setting is considered a strong asset.
- Skills:
- Strong knowledge of pharmacovigilance principles, adverse event reporting requirements, and safety case management processes.
- Experience developing and managing quality programs, deviation investigations, and corrective and preventive action (CAPA) processes.
- Ability to conduct root-cause analyses, identify trends, assess compliance risks, and implement effective corrective actions.
- Experience developing, delivering, and maintaining training and awareness programs.
- Ability to interpret and apply regulatory, contractual, and procedural requirements within operational environments.
Compensation:At BioScript, your base pay is one part of your total compensation package and isdeterminedwithin a range. Our pay ranges are based on the local cost of laborbenchmarks for each specific role, level, and geographic location.
Ready to make your mark?Ifyou'repassionate about transforming ideas into extraordinary results and excited to join a forward-thinking team, we want to hear from you!
