Associate Director Patient Safety (Remote - Us Based)

Purpose and Scope

The Associate Director of Patient Safety will play a leadership and team role in ICSR case review, periodic safety reports, and provide strategic and tactical advice and pharmacovigilance guidance for Tolmar products. This position will work in collaboration with the full Tolmar Patient Safety team to provide national and international strategic oversight of the periodic safety reporting compliance for global pharmacovigilance (PV; safety monitoring) at Tolmar. This role will also work collaboratively with Tolmar Technical Complaints to ensure all aspects of investigations are supported from a medical standpoint.

Essential Duties and Responsibilities

• Oversight and direction for Tolmar global and local PV activities with Business Partners and outside service vendors.

• Work collaboratively with outsourced vendor on the execution (both oversight and authorship where appropriate) of periodic aggregate safety reports (ASR, PBRER, etc.).
• Serve as a point of contact for pharmacovigilance (PV).
• Work on the Pharmacovigilance requirements including the the EU-RMP, and creating and maintaining the SOPs/WI, development, and maintenance global and local RMPs as required.
• Escalate issues with proposed mitigation strategies for pharmacovigilance.
• Evaluate current signal detection activities and recommend advances for continuous improvement.
• Work with service providers (PV service providers, patient support programs and customer support) to ensure all pharmacovigilance regulations are in place and followed.
• Oversee and supervise PV global outsourcing activities through identification, selection, negotiation, management, and maintenance of Good Pharmacovigilance Practices (GVP) and required PV activities in assigned projects or therapeutic areas.
• Work collaboratively with other PV experts within Tolmar and Business Partners and provide input for team decision making.
• Participate in Tolmar and vendor team meetings.
• Support local literature searches, search of the Canada Vigilance database, and Monthly reconciliation.
• Support revisions within the Company Core Data Sheet (CCDS), and Canadian Product Monograph(s), the US Package Insert for Tolmar products as needed. In addition, support Tolmar business partner label changes in required territories.
• Lead and support internal and external audit and inspections, and maintain audit and inspection readiness. Drive preparedness for regulatory authority inspection and internal audits for aggregate reporting processes.
• Collaborate with the ongoing aggregate review and analysis of commercial products’ safety data by reviewing adverse events and signal detection observations. Critically evaluate signal detection data, and review summary metrics and compliance reports and distribute reports within Tolmar per internal SOPs.
• Support training requirement for Pharmacovigilance in the appropriate Tolmar territories.
• Assist in 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.
• Other duties as assigned.
• Incorporate industry leading innovative initiatives aimed at improving effectiveness of surveillance, signal detection and risk mitigation activities for both marketed and developing therapies.
• Lead the responses to regulatory agencies for PV in relevant territories related to Tolmar product(s). Support Tolmar by providing or coordinating medical opinions related to ICSR inquiries, etc. with Tolmar products.
• Collaborate with Tolmar departments (e.g., Regulatory, Clinical, QA, and Legal), as required. Provide Tolmar management with safety- related information, as needed.
• ICSR and aggregate safety reports management oversight for Business Partners and contracted services.

Knowledge, Skills & Abilities

• Well-developed oral and written communication skills.
• Strong ability to lead people and coach, educate and mentor employees.
• Ability to work both independently and in a cross-functional team environment.
• Demonstrated competencies in international GVP and vendor management.
• Proficient computer skills with demonstrated experience in working with Microsoft suite of programs (Word, Excel, PowerPoint, Project, and Outlook).
• Ability to manage and prioritize multiple projects and tasks demonstrating strong organization and time management skills; to work in a fast-paced environment.
• Strong conflict resolution and problem solving skills.
• 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.

Core Values

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

Education & Experience

• Direct knowledge of national and international PV regulations and requirements.
• Direct and recent experience in postmarketing pharmacovigilance and vendor management of outsourced PV activities.
• Work productively in a dynamic environment.
• Must have high level of exposure in preparation, authorship, and submission of international periodic aggregate safety reports, ICSR analysis, signal detection and risk management, literature reporting, in Pharmacovigilance environment.
• Appropriate advanced medical degree with 8-12 or more years of experience within the pharmacovigilance industry experience.
• PharmD, MD, DNP strongly preferred (Bachelor’s in a medical discipline maybe considered with additional Pharmacovigilance industry experience).

Compensation and Benefits

• Benefits information: https://www.tolmar.com/careers/employee-benefits
• Pay: $155,000 - $165,000 annually, depending on experience
• Bonus eligible

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.

Working Conditions

• Remote work. Limited travel (5%) to Colorado for face-to-face meetings or to support audits or inspections.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Education

• Bachelors or better in Nursing or related field

• Medical Doctor or better in Management or related field
• PHD or better in Science or related field

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)