Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
This role is responsible for providing assistance and support in actively monitoring compliance metrics supporting the compilation of pharmacovigilance metrics related to ICSRs and aggregate reporting to ensure of the Pharmacovigilance (PV) System for local, regional, and global PV based on the principles of Good Pharmacovigilance Practice (GPvP) for Valeant’s pharma, consumer and medical device products.
This individual communicates and collaborates with Pharmacovigilance Management and cross-functional teams as necessary throughout the organization to optimize Pharmacovigilance quality and compliance. He/She communicates and collaborates with business partner counterparts as necessary to ensure compliance with the pharmacovigilance agreements.
The Compliance Specialist is responsible for ensuring accuracy and consistency of compliance investigations, investigation categorizations and corrections/corrective actions taken related to late Individual Case Safety Reports (ICSRs), late Aggregate Reports (ARs) and any other compliance investigations performed by Global PV Compliance team.
The Compliance Specialist will serve as the CAPA coordinator as an internal liaison between managers/departments to drive and collect pertinent information related to corrective/preventive actions (CAPA). S/he will support in management and tracking of CAPAs relevant to PV upon evaluation/review of PV audit/inspection findings as required.
Responsibilities include, but are not limited to the following:
- Post-audit management of data and actions including assignment of action owners, facilitation and capture of root cause analyses and response plans
- Act as Liaison between response action owners and internal/ external auditing body
-Manage responses and monitors commitments to internal/external audit and regulatory inspection findings.
- Manage and tracks CAPA commitments to completion and closure
Reporting Compliance and Metrics Responsibilities:
- Ensure all required ICSRs/medical device reports and aggregate reports are submitted in accordance with the federal and state and/or international regulations as applicable
- Participate in the investigation and review process of late reporting related to post-market adverse event reporting for the US, Europe, and other International regulatory bodies
-Performs root-cause analysis of any non-compliance reporting GPRM/GPPS process and training standards are effectively implemented, appropriately documented and consistent with departmental, organizational, corporate and regulatory requirements.
-Works with key stakeholders to define and ensure compliance with global business and regulatory requirements.
-Generates and analyzes metrics data and reports to supports industry benchmarking initiatives
Bachelor's degree, preferably in a healthcare-related field.
- Minimum of 4 years, pharmacovigilance case processing and/or PV compliance monitoring including metrics experience.
- Minimum of 2-5 years pharmacovigilance work experience strongly preferred.
-Minimum of 2 years pharmacovigilance work experience strongly preferred.
-Excellent analytical and process skills and the ability to apply these skills to Valeant GPRM/GPPS organization.
-Excellent communication, consulting, customer service and problem solving skills.
-Strong attention to detail along with the ability to meet deadlines.
-PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required).
-Excellent time management skills.
-Strong interpersonal skills and ability to interact with all levels of the organization
-Ability to work well in a matrixed, global team environment