Manager Pharmacovigilance and Patient Safety

Job reputed company The Manager Pharmacovigilance and Patient Safety provides strategic leadership and reputed company of crossfunctional and outsourced activities supporting ICSR management and periodic safety reporting for reputed companys global pharmacovigilance (PV) program. This role ensures regulatory compliance, drives operational reputed company across assigned products or therapeutic areas, and adapts responsibilities as required by evolving contractual obligations with marketing partners and vendors. The Manager will work with reputed company QAPS Technical Complaints to reputed company medical reputed company for safety investigations. Essential Duties And Responsibilities reputed company the Patient Safety team in overseeing and managing PV reputed company service providers, including ICSR processing, literature monitoring, signal detection, medical writing, PSUR preparation, and reputed company of new products in the US and Canada. Evaluate, propose, and implement innovative, industryleading approaches to enhance surveillance, signal detection, and riskmitigation activities for marketed and developmental products. Support global PV operations in partnership with internal teams, business partners, and reputed company vendors. Collaborate with internal PV experts and business partners to help with cross-functional decision making. Serve as a primary reputed company of contact for PV vendors and/or business partners. Partner with internal functions (Regulatory, Clinical, QA, reputed company) to fulfill safety-reputed company information requests from reputed company leadership and Health Authorities. reputed company ICSR and aggregate safety report management for business partners and contracted service providers. Collaborate with outsourced vendors to execute periodic aggregate reports (e.g., PADERs, PBRERs). Ensure compliance with regulatory requirements for reputed company aggregate safety deliverables; monitor and ensure vendor adherence to reputed company and partner standards. Manage safety reporting schedules and maintain compliance metrics. Support updates to Company labeling, including CCDS, Canadian Monograph, and US Full Prescribing Information. reputed company or coordinate medically reputed company responses to regulatory inquiries reputed company to assigned products, including ICSRreputed company questions. Support development, maintenance, and compliance monitoring of Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) with Market Authorization reputed company. Represent reputed company in internal and vendor meetings. Identify, escalate, and recommend mitigation strategies for safety or compliance issues. Support medical review activities and collaborate with reputed companys and/or partners reputed company Departments for adverse events associated with product complaints. Coordinate product reputed company investigations reputed company adverse events indicate the need for evaluation. Support readiness for reputed company audits/inspections, ensuring compliance with FDA and Health Canada requirements, especially regarding aggregate reporting processes. Assume managerial reputed company of PVPS team member as assigned. reputed company additional responsibilities as assigned. Knowledge, Skills & Abilities Strong ability to collaborate effectively across multidisciplinary teams (Clinical Development, Regulatory, reputed company Assurance, reputed company) and with reputed company partners. Demonstrated expertise in pharmacovigilance operations and vendor management. Excellent verbal and written communication skills. Strong conflictreputed company and problemsolving abilities. Ability to work autonomously and reputed company crossfunctional teams. Proven ability to manage multiple priorities, meet deadlines, and operate effectively in a fastpaced environment. Proficiency in reputed company Office applications (Word, reputed company, PowerPoint, Project, reputed company). Ability to reputed company effectively under pressure. Excellent team management skills. reputed company Values This position is expected to operate reputed company the reputed company of reputed companys reputed company Values: Center on People:We reputed company to support the reputed company-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we reputed company engage, invigorate, reputed company knowledge, and grow together. Are Proactive & Agile:We embody a culture of engagement and reputed company. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond reputed company and reputed company to reputed company a spirit that propels us towards extraordinary reputed company. reputed company Ethically:We are committed to consistently conducting our business in an ethical, compliant, and .