Pharmacovigilance Operations Manager

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Revance

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

☁️ SaaS

📋 Compliance

🤝 B2B

💰 $100M Post-IPO Equity - Revance Therapeutics on 2024-03

SaaS • Compliance • B2B

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📋 Description

• Leads global Patient Safety Operations and effectively manages select safety surveillance projects for multiple product categories, including prescription drugs, class I, II, and III medical devices, OTC drugs, and cosmetics. • Manages communications with vendors, CROs, QPPVs, and partners regarding the evaluation, processing, and reconciliation of case reports (ICSRs, MDRs, cosmetic AE reports). • Manages communications with the clinical development team regarding safety data exchange and reconciliation between clinical and safety databases for clinical studies. • Ensures that all safety reports received by the Patient Safety group from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. • Reviews all cases to ensure the accuracy, integrity and completeness of information entered in the safety database. • Ensures that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as required and on time. • Maintains the company electronic safety reporting portal, collates suggested inputs from cross-functional groups, and communicates with IT to ensure appropriate implementation. • Leads PV compliance monitoring. • Maintains the company core Pharmacovigilance System Master File (PSMF). Collates inputs from relevant cross-functional partners and updates the PSMF quarterly. Coordinates regional PSMF updates with QPPVs. • Maintains and updates PV SOPs, vendor Joint Operating Guidelines (JOGs) and relevant departmental policies. • Ensures continuous inspection and audit readiness of the Revance pharmacovigilance system by maintaining compliant processes, complete and inspection-ready documentation, effective vendor oversight, and measurable quality and compliance metrics. • Monitors and identifies possible trends and concerns related to the use of Revance products, and key competitor products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety. • Leads signal detection and analysis, as well as preparation and submission of signal reports.

🎯 Requirements

• Master's degree in Life Sciences, Pharmacology, Public Health, Nursing, or a related scientific field with 6–8+ years of pharmacovigilance experience, OR Bachelor's degree with 8+ years of relevant experience • Progressive experience within pharmaceutical, biotechnology, or medical device environments • Direct experience with: • End-to-end case processing and ICSR/MDR lifecycle management • Safety databases (Argus preferred) • Signal detection and safety surveillance activities • Strong understanding of: • Global GVP regulations and ICH guidelines • Pharmacovigilance compliance requirements • Regulated processes and clinical trial lifecycle • Experience analyzing and interpreting safety data and assessing clinical relevance • Demonstrated ability to manage multiple priorities and lead projects independently • Strong cross-functional collaboration and relationship management skills • Excellent written and verbal communication skills • High attention to detail and strong organizational skills

🏖️ Benefits

• Competitive Compensation including base salary and annual performance bonus. • Flexible PTO, holidays, and parental leave. • Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!