Tolmar · 1 day ago
Manager Pharmacovigilance and Patient Safety
Windsor, CO
Full-time
Hybrid
Senior Level
$140K/yr - $150K/yr
5+ years expTolmar is a company that provides strategic leadership in pharmacovigilance and patient safety. The Manager of Pharmacovigilance and Patient Safety will oversee cross-functional and outsourced activities, ensuring regulatory compliance and operational excellence in ICSR management and safety reporting.
BiotechnologyHealth CareManufacturing
Responsibilities
Lead the Patient Safety team in overseeing and managing PV external service providers, including ICSR processing, literature monitoring, signal detection, medical writing, PSUR preparation, and onboarding 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 point of contact for PV vendors and/or business partners
Partner with internal functions (Regulatory, Clinical, QA, Legal) to fulfill safety-related information requests from Tolmar leadership and Health Authorities
Oversee 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 all aggregate safety deliverables; monitor and ensure vendor adherence to Tolmar 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
Provide or coordinate medically sound responses to regulatory inquiries related to assigned products, including ICSR‑related questions
Support development, maintenance, and compliance monitoring of Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) with Market Authorization Holders
Represent Tolmar in internal and vendor meetings
Identify, escalate, and recommend mitigation strategies for safety or compliance issues
Support medical review activities and collaborate with Tolmar’s and/or partners’ Quality Departments for adverse events associated with product complaints
Coordinate product quality investigations when 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 oversight of PVPS team member as assigned
Perform additional responsibilities as assigned
Qualification
Required
PharmD or Ph.D., MD, BSN or equivalent required
5 or more years of experience within the pharmaceutical or healthcare-related 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 within an aggregate reporting function
Direct and recent experience in vendor management of outsourced PV activities
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 within cross-functional teams
Proven ability to manage multiple priorities, meet deadlines, and operate effectively in a fast-paced environment
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project, Outlook)
Ability to perform effectively under pressure
Excellent team management skills
Preferred
Prior management experience preferred
Benefits
Bonus eligible
Benefits information: https://www.tolmar.com/careers/employee-benefits
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
1001-5000 employees
H1B Sponsorship
Tolmar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
Recent News
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