The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-prescription pharmaceutical products.
Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences. To support our Worldwide Research & Development operation, we are building a complex R&D support center in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.
Lead Compliance Investigator
The responsibilities & the impact YOU will have:
Be the Subject Matter Expert for compliance investigations
Manage and ensure accuracy/consistency of compliance investigations, investigation categorizations and corrective actions taken in relation to late Individual Case Safety Reports (ICSRs), Late Aggregate Reports and/or any other compliance investigations performed by the Compliance Operations team and/or preliminary investigations performed by vendors.
Balance day to day process issues and queries from Compliance Investigators and/or Vendor resources per documented procedures.
Review compliance documentation, including categorizations, corrections, corrective actions and deviation memos for accuracy and consistency.
Ensure appropriate corrective/preventative actions and/or effectiveness measures for late ICSR, Alliance Partner, and/or Aggregate Report CAPAs and other compliance related CAPAs are documented.
Accountable for prioritizing and ensuring deliverables are completed on time, are accurate, consistent and aligned with documented procedures.
Participate in and/or lead compliance initiatives with cross-sector internal functional teams and/or external Alliance Partners.
Build compliance presentations and present compliance data in various forums to all levels of management within the Global Medical Safety Organization and/or Office of Consumer Medical Safety Organization.
Assist in developing training and procedural guidance documents for internal resources and vendors performing compliance investigations.
Minimum of 4 years of experience in pharmacovigilance case processing and/or PV compliance monitoring.
- Understanding of GxP requirements.
Global pharmacovigilance experience required with knowledge of global PV laws and regulations.
Excellent communication and writing skills. Ability to influence without authority.
Minimum of bachelor’s degree in relevant discipline (Business, Science, Medical, Operations, etc.).
This is what awaits YOU at J&J:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
Many opportunities to work on challenging projects and assignments.
Possibilities for further personal as well as professional development.
- Many employee benefits.
Johnson & Johnson (Poland) Sp. z.o.o. (7815)