Manager/AD, Global Pharmacovigilance

Description

This is a multi-level posting. Candidates will be hired in at the level based on education, experience, and business need.

 

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

 

This role ensures Pharmacovigilance compliance with all competent authorities (including but not limited to FDA, USDA-APHIS, EMA, CFIA etc..) as described in the corporate and Boehringer AH PV SOPs, FDA 21 CFR, USDA 9 CFR, and current European regulations. This role will review, assess, and approve product/adverse event complaints for Boehringer AH Product globally and submit to appropriate authorities as required. The incumbent provides expert guidance to Global Pharmacovigilance (PV) Management around ADE analysis, interpretation of PV trends and/or signal detection.

 

This role provides expert guidance and functional support to the Global PV Team and leads data quality of complaint handling process to ensure compliance with all competent authorities. This role performs triage and case review of adverse events for Boehringer AH products globally. The incumbent is responsible for and develops technical training and monitors the technical expertise of other personnel in the department.

 

This role contributes to the knowledge base of the department and acts as a key resource for internal and external colleagues. The position holder is recognized as a Subject Matter Expert in Pharmacovigilance Data/Quality and case review by internal and external colleagues and acts as a resource and trainer for colleagues.

Duties and Responsibilities

• Reviews and evaluates all complaints for accurate and consistent data, coding, case assessments and submission to applicable regulatory authorities.
• Leads training on implementation of changes to case processing or data entry.
• Is considered a Subject Matter Expert regarding PV case processing and data entry.
• Develops and Guides training for pharmacovigilance procedures and processes as necessary
• Responsible for and guides the evaluation of case data.
• Performs Data Quality and compliance reviews as assigned for External Partners providing outsourced services for all Boehringer Products globally.
• Performs re-training for External Partners as needed.
• Independently applies basic scientific principles, performs literature searches, keeps abreast of literature in own field and attends scientific meetings; demonstrates a contemporary level of technical proficiency in field.
• Performs all company business in accordance with all regulations and company policies and procedures.
• Immediately reports noted/observed violations to management.
• Prepares regulatory reports; 3 Day Alerts, 15 Day Alerts, Periodic Reports and provides data for USDA APHIS inquiries and/or CVM follow up case reports in a timely manner as required.
• Supports coordination and production of PV related reports and documents including but not limited to: Safety Update Reports (SUR), Product Benefit Risk Reports including Annual Statement, PV statements, Reconciliation reports in compliance with internal procedures
• Maintains compliance with corporate procedures and with global regulatory requirements.
• Provides support during audits and inspections as needed.
• Manages deviations, Corrective Action Preventive Actions (CAPAs) and other PV compliance issues to resolution.
• Provides expert input on the PSMF iteration update compilation, manage the documentation of the iteration and file the updated versions as per internal process.
• Manages the collection, review, and approval of Global PV procedures and quality documents (SOPs/Guidelines).
• Participates in the drafting, review and implementation of Global PV SOPs and related documents, and this within an environment of continuous improvement.
• Initiates and maintains document and information storage and retrieval functions for Global PV Teams.
• Evaluates and acts to ensure document quality.
• Resolves issues regarding documentation to be archived.
• Determines appropriate distribution for document and procedure updates.
• Proactively contributes as an expert to developing and managing the Gl