Senior Manager, Pharmacovigilance Compliance and Inspection Readiness 
Position Responsibilities 
  • Leads Worldwide Patient Safety (WWPS) inspections and audits both proactively in terms of readiness, preparation and post-evaluation ensuring implementation of corrective and preventative actions (CAPAs). Works with R&D Global Quality Team.
  • Supports the creation, monitoring and resolution of Deviation Investigations and Audit/Inspection Findings as needed.
  • Leads Investigations related to Deviations or Audit/Inspection Findings and provides end to end support in identifying risks to the Quality systems and in developing appropriate CAPAs and effectiveness checks.
  • Manages the audit and inspection process of key business partner and CRO relations and adherence to contractual agreements in regard to compliance. Trends and analyzes deviations from various sources. Shares and communicates the result of analysis and intelligence with stakeholders as appropriate.
  • Work with WWPS – PV Compliance and Quality Risk Management in developing, implementing and/or coordinating quality monitoring and compliance monitoring programs not directly related to information technology.
  • Assist in the development of departmental standard operating procedures. Participate in the preparation and conduct of departmental training, where required, to support audit, inspection readiness and other related continuous improvement initiatives impacting WWPS.
  • As appropriate, partners with WWPS and service provider personnel to resolve quality issues as well as to optimize processes for reliability, effectiveness and efficiency.
  • Serves as a source of information pertaining to global safety regulations for internal and external customers involved in pharmacovigilance activities.
  • Communicates vision and supporting strategies with clarity, consistency, and impact to align stakeholder activities regarding safety reporting requirements.
Degree / Experience Requirements 
  • A Bachelor’s degree with the minimum of eight years pharmaceutical industry experience, and with a minimum of five years in pharmacovigilance, drug development, clinical development, regulatory affairs or related industry experience
  • Extensive knowledge of worldwide regulations pertaining to pharmacovigilance.
  • Prior experience in participating or leading audit or inspection program in the pharmaceutical industry.
  • Prior experience with providing guidance to senior management on regulatory and compliance issues germane to pharmacovigilance.
  • Strong scientific background in chemical or biomedical related field (postgraduate training or equivalent experience preferred).
Key Competency Requirements 
  • Successful and creative negotiation of difficult compliance issues.
  • Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.        
  • Advocates the highest standards of quality and compliance.
  • Maintains an in-depth knowledge of global governmental regulations that impact the research, development and marketing of medicines and devices as well as relevant Company policies and procedures associated with pharmacovigilance within the area of expertise, maintains awareness of industry trends and developments.
  • Demonstrates ability to analyze and interpret complex regulations to determine impact on company operations and policies and in developing action plans to optimize compliance.
  • Possesses excellent communication skills which are used to convey recommendations for quality improvements to our internal and external customers.
  • Demonstrated effective oral/written communication and strong interpersonal relationship skills.
Competence in the use of computers including familiarity with; 
  • Windows, word processing and data management software.
  • Microsoft Office Suite
  • Corporate Safety Database
  • Web-based employee time tracking
  • Document management system for authoring, reviewing and approving electronic documentation (i.e., SharePoint, PDHQ, etc.) Corporate learning management system
  • Corporate Quality Management System

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