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 ensuring oversight and monitoring 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.
Implements quality policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations by interpreting federal and state and/or international regulations as they apply to products, processes, practices and procedures. This position has the responsibility and authority to manage site compliance-related activities.
This position serves as the Audit Site Point of Contact and providing support for all internal (i.e., Sector and Corporate) and external (i.e., Notified Body, government agency, third-party certification bodies, etc.) audits.
This position has responsibility for ensuring the creation of relevant internal standards (metrics) by which to measure compliance, ensure meaningful reports for effective management oversight of GPRM/GPPS functions and provide supporting data to drive process improvement initiatives.
Additionally, this role is responsible for managing and coordinating/supporting internal and external GPRM/GPPS related audits/inspections, monitoring the effectiveness of existing standards to ensure compliance, quality, and consistency in implementation, and implementing/maintaining the GPRM/GPPS CAPA process.
Responsibilities include, but are not limited to the following:
Audit/Inspection and CAPA Responsibilities:
-Interfaces with regulators or auditors during regulatory inspections and internal/external audits.
-Host/co-host inspections/audits of Global PV system
- 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
- Support response owners through champion program for root cause analyses and audit plan
- Review and approve all (internal and external) audit root cause analyses and response plans
- Report and maintain audit data for metrics.
-Manage responses and monitors commitments to internal/external audit and regulatory inspection findings.
-Interacts frequently with other GPRM/GPPS team members , GPRM/GPPS Management, during PV inspections, auditors and Valeant business partners, as appropriate
-Ensures GPRM/GPPS team is in a constant state of Inspection Readiness.
Reporting Compliance and Metrics Responsibilities:
-Collaborates with business partners to resolve compliance issues which may impact contractual agreements
-Drives Pharmacovigilance compliance based on expectations and/or requirements of regulatory agencies, internal processes, and external business partner obligations.
- Ensure all required 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.
-Provides oversight to GPRM/GPPS Business Continuity Plans.
-Develops, evaluates and monitors internal/external compliance metrics.
-Ensures the creation of relevant internal standards (metrics) to support management oversight of GPRM/GPPS functions
-Ensures the generation and analysis of relevant internal standards (metrics) to drive process improvement initiatives.
-Develops new tools and optimizes existing tool(s) for generating and analyzing effective, ongoing metrics data.
-Generates and analyzes metrics data and reports to supports industry benchmarking initiatives.
Bachelor's degree, preferably in a healthcare-related field.
Minimum of 5 years auditing, metrics and/or compliance monitoring experience.
-Minimum of 2-5 years pharmacovigilance work experience strongly preferred.
-Minimum of 2-5 years auditing, metrics and/or compliance monitoring experience.
-Minimum of 5 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
-Experience in Medical Device post-market vigilance (complaint management) required
-Expertise in complaint handling including MDR and MDV reporting
-Experienced in MedWatch and international adverse event reporting requirements;
-Experienced in FDA Quality System Regulations- 21 CFR part 820, Part 803 and Part 806 and, Medical Device Directive and MEDDEV guidance documents, associated harmonized standards, ISO 13485, and related quality standards
Valeant is an EEO/AA employer M/F/D/V