Associate Director, Patient Safety
Posted on Apr 5, 2021 by Tolmar Inc
The Associate Director of Patient Safety will play a leadership and team focus role in ICSR case review, periodic safety reports, and provide strategic and tactical advice and guidance for all Tolmar products. Provides national and international strategic oversight of the cross-functional and outsourced management for aggregate 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 priorities of the role. 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
Provide oversight and direction for Tolmar global and local 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.
Oversee and supervise PV global outsourcing activities through identification, selection, negotiation, management, and maintenance of Good Pharmacovigilance Practices (GPVP) and required PV activities in assigned projects or therapeutic areas.
Collaborate with Tolmar departments (eg, Regulatory, Clinical, QA, and Legal), as needed. Provide Tolmar management with safety- related information, as needed.
Support the oversight of individual case safety reports (ICSR) review, MedDRA coding, Sponsor's positioning, case follow up, benefit-risk assessment for both marketed and investigational products.
ICSR and aggregate safety reports management oversight for Business Partners and contracted services.
Work collaboratively with outsourced vendor on the execution (both oversight and authorship where appropriate) of periodic aggregate safety reports (PADERs, PBRER, DSURS, etc.).
Evaluate current signal detection activities and recommend advances for continuous improvement
Manage compliance with all national and international regulatory requirements for periodic aggregate safety report deliverables. Ensure vendor compliance with Tolmar's and Business Partners' requirements.
Partner cross-functionally internally to define reporting and submission requirements to enable vendor resource planning to deliver all safety reports.
Lead safety reporting schedules and maintain metrics for compliance reporting.
Lead 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 revisions within the Company Core Data Sheet (CCDS), and US Full Prescribing Information as needed.
Lead the 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.
Manage 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. Author Health Hazard Evaluations (HHE) in collaboration with other medical professionals.
Coordinate when an adverse event report warrants product quality investigations, when requested.
Incorporate industry leading innovative initiatives aimed at improving effectiveness of surveillance, signal detection and risk mitigation activities for both marketed and developing therapies.
Lead and support internal and external audit activities and maintain audit and inspection readiness. Drive preparedness for regulatory authority inspection and internal audits for aggregate reporting processes. Serve as the primary functional interface from Pharmacovigilance for subject matter expertise on aggregate safety reporting content.
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.
Strong ability to lead people and coach, educate and mentor employees.
Demonstrated competencies in international GPVP 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).
The Associate Director, 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
Doctorate level medical degree (PharmD or MD) preferred; BSN, R.Ph. or equivalent required.
12 or more years of experience with substantial pharmaceutical or healthcare-related industry experience.
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.
Demonstrated experience in people management and well-developed skills in cross-functional team communication ideally within an Aggregate reporting, ICSR reporting, signal detection and risk management, and literature review operations.
Direct and recent experience in post-marketing pharmacovigilance and vendor management of outsourced PV activities.
Direct knowledge of national and international PV regulations and requirements for both NDA and ANDA products.
Compensation and Benefits
Annual pay range $155,000 - $165,000
Link to general benefits information:
This position is remote. Minimal domestic or international travel may occur.
Doctorate or better.
Masters or better in Nursing or related field.