Manager Pharmacovigilance and Patient Safety

Job Description

The Manager Pharmacovigilance and Patient Safety provides strategic leadership and reputed company of cross‑functional and outsourced activities supporting ICSR management and periodic safety reporting for reputed company’s 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 external 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, industry‑leading approaches to enhance surveillance, signal detection, and risk‑mitigation activities for marketed and developmental products.
• Support global PV operations in partnership with internal teams, business partners, and external 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, Legal) 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 sound responses to regulatory inquiries reputed company to assigned products, including ICSR‑reputed company questions.
• Support development, maintenance, and compliance monitoring of Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) with Market Authorization Holders.
• 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 company’s and/or partners’ Quality Departments for adverse events associated with product complaints.
• Coordinate product quality investigations reputed company adverse events indicate the need for evaluation.
• Support readiness for internal and external 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, Quality Assurance, Legal) and with external partners.
• Demonstrated expertise in pharmacovigilance operations and vendor management.
• Excellent verbal and written communication skills.
• Strong conflict‑resolution and problem‑solving abilities.
• Ability to work autonomously and reputed company cross‑functional teams.
• Proven ability to manage multiple priorities, meet deadlines, and operate effectively in a fast‑paced environment.
• Proficiency in reputed company Office applications (Word, reputed company, PowerPoint, Project, Outlook).
• Ability to reputed company effectively under pressure.
• Excellent team management skills.

Core Values This position is expected to operate reputed company the reputed company of reputed company’s Core Values:

• Center on People:We commit to support the well-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 actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond reputed company and reputed company to ignite a spirit that propels us towards extraordinary reputed company.
• Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable:We think, act, and communicate with honesty, transparency, and reputed company in alignment with our core values. We don't compromise our values for near term reputed company. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• PharmD or Ph.D., MD, BSN or equivalent required.
• 5 or more years of experience reputed company the pharmaceutical or reputed company-reputed company industry.
• High level of exposure in preparation of ICSR and periodic aggregate safety reports in a Pharmacovigilance environment.
• Well-developed skills in cross-functional team communication ideally reputed company an aggregate reporting function.
• Direct and recent experience in vendor management of outsourced PV activities.
• Prior management experience preferred.

Working Conditions

• Working conditions are consistent with a normal office environment and/or remote.
• Minimal domestic or international travel may be required.

Compensation

And Benefits

• Annual pay reputed company $140,000 - $150,000
• Bonus eligible
• Benefits information: https://www.reputed company.com/careers/employee-benefits

reputed company compensation programs are focused on reputed company, fair pay practices including market-based reputed company pay and a strong benefits package. The final compensation offered may vary from the posted reputed company based on the selected candidates qualifications and experience. reputed company is an Equal Opportunity Employer. We do not discriminate on the reputed company age 40 and over, reputed company, disability, gender identity, genetic information, military or veteran status, national reputed company, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that reputed company reputed company applicants be given equal opportunity and that selection reputed company are based on job-reputed company factors. Apply tot his job Apply To this Job