Core Hours: Monday - Friday, 8am-5pm MST

Job Description

The Manager Patient Safety provides strategic oversight of the cross-functional and outsourced management for ICSR and periodic safety reporting compliance for global pharmacovigilance (PV; safety monitoring) at Tolmar and provides direction for aspects of pharmacovigilance activities in specific assigned projects or therapeutic areas. Contractual obligations with each marketing partner and vendor vary over time and may require adjustments to the role of the Manager Patient Safety. This role will also work collaboratively with the Tolmar Technical Complaints to ensure all aspects of investigations are supported from a medical standpoint.

Essential Duties and Responsibilities

• Lead the Patient Safety team in the oversight and management of PV external service provider including PV services, medical writing, ICSR processing, literature processing, signal detection, PSUR generation, and implementing new products for both US and Canada
• Define, determine the feasibility and incorporate industry leading innovative initiatives aimed at improving effectiveness of surveillance, signal detection and risk mitigation activities for both marketed and developing therapies.
• Assist with Tolmar global PV activities with Business Partners and outside service vendors.
• Work collaboratively with other PV experts within Tolmar and Business Partners and provide input for team decision making.
• Serve as a point of contact for pharmacovigilance (PV) vendors.
• Collaborate with Tolmar departments (e.g., Regulatory, Clinical, QA, and Legal), as needed. Provide Tolmar management and Health Authorities with safety- related information and data requests, as needed.
• ICSR and aggregate safety reports management oversight for Business Partners and contracted services.
• Work collaboratively with outsourced vendor on the execution of periodic aggregate safety reports (PADERs, PBRER, etc.).
• Manage compliance with all regulatory requirements for periodic aggregate safety report deliverables. Ensure vendor compliance with Tolmar’s and Business Partners’ requirements.
• Oversee safety reporting schedules and maintain metrics for compliance reporting.
• Support revisions within the Company labeling such as the Company Core Data Sheet (CCDS), the Canadian Monograph and US Full Prescribing Information as needed.
• Provide significant responses to regulatory agencies related to the assigned product(s). Support Tolmar by providing or coordinating medical opinions related to ICSR inquiries, etc. with Tolmar products.
• Assist with the management of Safety Data Exchange Agreement (SDEA) and Pharmacovigilance Agreements (PVA) development and updates for Market Authorization Holders (MAH), as needed, to comply with regulations. Confirm compliance with all SDEAs and PVAs.
• Participate in Tolmar and vendor team meetings as a Tolmar representative.
• Escalate issues with proposed mitigation strategies.
• Support medical review and coordination with Tolmar’s and/or Business Partner’s Quality Department, when an adverse event is associated with a product complaint.
• Coordinate when an adverse event report warrants product quality investigations, when requested.
• Support internal and external audit and inspection activities and maintain audit and inspection readiness for both FDA and Health Canada. Drive preparedness for regulatory authority inspection and internal audits for aggregate reporting processes.
• Perform other related duties, as assigned.

Knowledge, Skills & Abilities

• Ability to interact collaboratively and effectively in a team environment (including Clinical Development, Regulatory, Quality Assurance, and Legal), as well as with external colleagues and vendors.
• Demonstrated competencies in Pharmacovigilance and vendor management.
• Well-developed verbal and written communication skills.
• Strong conflict resolution and problem solving skills.
• Ability to work both independently and in a cross-functional team environment.
• Ability to manage and prioritize multiple projects and tasks demonstrating strong organization and time management skills; to work in a fast paced environment.
• Proficient computer skills with demonstrated experience in working with Microsoft suite of programs (Word, Excel, PowerPoint, Project, and Outlook).

• Ability to work productively in a high pressure environment.

Core Values

• The Manager Patient Safety is expected to operate within the framework of Tolmar’s Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

• PharmD, R.Ph., 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.

Working Conditions

• This position is remote. Minimal domestic or international travel may be required.

Compensation and Benefits

• Annual pay range $130,000 - $140,000
• Bonus eligible
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)