Specialist/SR Specialist, Pharmacovigilance

Description

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 pharmacovigilance position supports data quality of complaint handling process to ensure compliance with all competent authorities. This role performs triage and case review of adverse events for BIAH products manufactured or sold in the US and is recognized as a Subject Matter Expert in Data/Quality by customers and acts as a resource and trainer for colleagues.

Duties & Responsibilities

• Participates in the processing of adverse event and TPC reports and data quality checks in compliance with applicable regulations and BI procedures.


• Performs individual case reviews.


• Performs triage of ADEs and Inquiries.


• Submits TPC & ADE Investigation requests to QA.


• Develops & executes queries.


• Guides PV & VeTS management in maintaining compliance with regulatory requirements and BI procedures.


• Reviews case information in individual case reports or line listings as requested by management.


• Reviews advertising and promotional material and prepares it for regulatory submission, if applicable.


• Actively Participates in internal or external inspections as needed.


• Generates and circulates compliance reports to PV management.


• Guides PV & VeTS with daily processes and issues.


• Responds to VeTS questions regarding data entry, provides feedback via ABT, OCS, and email regarding corrections/issues identified during case review.


• 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.


• Supports and monitors compliance of complaint handling process.


• Tracks QA investigations for DER submissions.


• Helps maintain PV-Works dictionary.


• Participates in the drafting, review and implementation of department SOP´s and Related Documents within an environment of continuous improvement.


• Completes other tasks as assigned by supervisor.


• Performs all company business in accordance with all regulations and company policies and procedures.


• Immediately reports noted/observed violations to management.


• Demonstrates high ethical and professional standards with all business contacts to maintain company´s excellent reputation in the community.

Requirements

SR Specialist:

• Bachelor´s degree in Life Science with five (5) years´ experience in a regulatory/compliance (GMP) environment and with at least two to three (2-3) years direct experience in complaint handling, PV & Data Quality.

Specialist:

• Associates Degree or Veterinary Technician degree from an accredited institution required, with two (2) years of experience working in a regulatory/compliance, or equivalent GMP environment with a focus on complaint handling, PV & Data Quality.


• Bachelors Degree from an accredited institution in Life Science preferred.

Functional Competencies:

• Knowledge of Pharmaceutical Life Cycle Process


• Knowledge of Reg Requirement & Compliance


• Leveraging Strategic Relationships


• Managing Conflict


• Negotiation Skills


• Market knowledge

Foundational Competencies:

• Accountability and Ownership


• Integrity and trust


• Values diversity and inclusion

Core Competencies:

• Must have a basic knowledge working with Microsoft Office products and databases.


• Must have strong organizational and time management skills required in order to work with diverse cultures and multiple departments.


• Ability to work in a team environment or experience working in a project environment.


• Strong oral and written communication skills are required in order to work with diverse cultures and multiple departments.


• Ability to remain calm under pressure and work to meet strict regulatory timelines.


• Attention to detail, quality focused and strong technical and problem solving skills.


• Ability to manage conflict and provide solutions to balance business need with user friendliness.


• Occasionally may need to be flexible with working with team members in different time zones.


• Experience working within regulated pharmaceutical and/or biological industry environments.


• Must possess a strong understanding of basic veterinary practice issues and procedures.


• Must be able to understand and apply relevant GMPs and have an understanding of pharmacovigilance and complaint handling compliance requirements.