Manager Pharmacovigilance and Compliance Lead (Remote)

Core Work Schedule is Monday - Friday, 8:00 - 5:00 Mountain Time

Purpose and Scope

The Manager Pharmacovigilance (PV) and Compliance Lead will collaborate with departmental colleagues and cross-functional teams to ensure compliance with safety regulations.  This includes but is not limited to contributing to the development of pharmacovigilance processes and procedures; Staying up-to-date with evolving pharmacovigilance guidelines and best practices; and Vendor and Business Partner oversight at Tolmar.

 Essential Duties and Responsibilities

• Assist the Pharmacovigilance and Patient Safety team in the oversight and management of PV external service provider of all PV services, while monitoring Key Performance Indicators (KPIs).
• Support Deviation documentation and CAPAs.
• Define and determine the feasibility of incorporating industry leading innovative initiatives aimed at improving effectiveness of surveillance, signal detection and risk mitigation activities for both marketed and developing therapies.
• Monitor compliance of Tolmar’s Business Partners and outside service vendors to pharmacovigilance regulations and terms of Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) and generate metrics for Senior Management.
• Serve as a point of Contact for Tolmar Business Partners and PV Vendors.
• Work collaboratively with other PV experts within Tolmar and Business Partners and provide input for team decision making.
• Collaborate with Tolmar departments (e.g., Regulatory, Medical Affairs, Clinical, QA, and Legal), as needed. Provide Tolmar management 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 vendors on the execution of periodic aggregate safety reports (PADERs, PBRER, etc.).
• Manage compliance with all regulatory requirements for aggregate safety report deliverables. Ensure vendor compliance with Tolmar’s and Business Partners’ requirements.
• Oversee safety reporting schedules and maintain metrics for compliance reporting.
• Lead in the initiation and revision of departmental Standard Operation Procedures (SOPs).
• Assist with the management of PVA and SDEA development and updates for Market Authorization Holders (MAH), as needed, to comply with regulations. Confirm compliance with all PVAs and SDEAs.
• Participate in Tolmar, Tolmar PV Department and vendor team meetings as a Tolmar representative, as needed.
• Escalate issues with proposed mitigation strategies.
• Support internal and external audit and inspection activities and maintain audit and inspection readiness especially for both FDA and Health Canada. Drive preparedness for regulatory authority inspections, business partner, and internal audits for PV responsibilities. This would include evaluating proposed corrections, CAPAs for compliance with applicable regulations, guidelines and applicable Tolmar policies.
• Perform other related duties, as assigned.

 Knowledge, Skills & Abilities 

• Must have a high level of experience in the following areas:
• Inspections and audits;
• Aggregate Safety Reports;
• Vendor Management; and
• Pharmacovigilance Compliance.
• Demonstrate experience in management of personnel and well-developed skills in cross-functional team communication.
• Experience in the authoring of Pharmacovigilance-related SOPs.
• Experience with Marketing and Business Partners.
• Working knowledge of Pharmacovigilance safety databases, such as Argus, ARISg, etc.)
• Working knowledge of Veeva QMS is a plus.
• Strong computer skills (MS Office), especially Excel.
• Able to work with international colleagues as well as remotely.
• Able to work productively in a high-pressure environment.

Core Values

• The Manager Pharmacovigilance and Compliance Lead 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.

Compensation and Benefits

• Annual pay range $135,000 - $145,000
• Bonus eligible
• Benefits information: 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. 

Working Conditions

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

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.