Revance
Manager,PharmacovigilanceOperations
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“Manager, Pharmacovigilance Operations at Revance. Skills: Pharmacovigilance operations, Case processing, Signal detection, Regulatory compliance. Lead patient safety operations. Manage select safety surveillance projects”
What You'll Achieve.
Measurable quality and compliance metrics
Industry & Context.
Assessing clinical relevance
What They're Looking For.
Must Have
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, 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, cross-functional collaboration and relationship management skills, Excellent written and verbal communication skills, High attention to detail and organizational skills
Nice to Have
Completed MD, PhD, or PharmD degree with 2 or more years of clinical or academic experience and 3 or more years of patient safety experience in a pharmaceutical or medical device company, understanding of: Audit and inspection management, Risk management plans (RMPs), Company Core Data Sheet (CCDS) development, Hands-on experience with regulatory inspections, internal and external audits, Exposure to global PV systems and multi-region compliance, Experience with new market entries, Experience developing aggregate reports (PSUR/PBRER, DSUR)
What You'll Do.
Lead patient safety operations
Manage select safety surveillance projects
Manage communications with vendors
Manage communications with clinical development team
Ensure safety reports processed and reported
Review cases for accuracy
Ensure safety reports submitted on time
Maintain electronic safety reporting portal
Lead PV compliance monitoring
Maintain Pharmacovigilance System Master File
Update PSMF quarterly
Coordinate regional PSMF updates
Maintain and update PV SOPs
Ensure inspection and audit readiness
Monitor and identify trends
Lead signal detection and analysis
Prepare and submit signal reports
How You'll Work.
Team & Collaboration
Partner closely with Clinical Development, Regulatory Affairs, Medical Information, Quality, Medical Affairs, Customer Support, external vendors, and global stakeholders; Collates inputs from cross-functional groups; Collates inputs from relevant cross-functional partners
Communication Scope
Excellent written and verbal communication skills
Process & Methodology
Project leadership capabilities, Manage multiple priorities, Lead projects independently
Full Job Description
Position Summary: We are seeking a collaborative, proactive, and detail-oriented Manager, Pharmacovigilance Operations to lead patient safety operations across a diverse product portfolio. This role serves as a key contributor within the Patient Safety organization and is responsible for leading day-to-day pharmacovigilance operations, supporting safety surveillance activities, ensuring compliance with global regulations, and maintaining inspection-ready processes and systems. The individual will partner closely with Clinical Development, Regulatory Affairs, Medical Information, Quality, Medical Affairs, Customer Support, external vendors, and global stakeholders to support compliant and efficient safety operations. The ideal candidate brings deep pharmacovigilance operations expertise, strong project leadership capabilities, and a passion for process excellence within a fast-paced and evolving environment. Key Responsibilities: 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. Safety Operations 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 th
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