Merck Organon - Associate Director, PV Training & Documentation in North Wales, Pennsylvania
Under the direction and oversight of the Pharmacovigilance (PV) Process and Standards Director, the Training and Documentation Lead Associate Director develops, maintains, and provides the necessary trainings and documentation of processes to ensure compliance with PV regulations. The Associate Director acts as a subject matter expert on PV regulations relevant to training and documentation.
Lead the development, delivery, implementation, maintenance and tracking of the global PV training strategy (e.g. training matrix, processes, metrics, and effectiveness verifications).
Manage and maintain all PV-controlled documents (e.g. PSMF, SOPs, Safety System User Manual, etc.).
Assist in the authoring, reviewing and implementation of new PV-controlled SOPs and supportive documents.
Represent PV on cross-functional initiatives and externally with business partners and vendors to ensure PV SOP alignment and compliance.
Provide input and review of responses to regulatory agency questions related to training and documentation procedures.
Participate in various important pharmacovigilance processes, IT and quality initiatives contributing to continuous process improvement of PV procedures and innovative solutions.
Participate in inspection readiness activities and preparation as needed.
Qualification, Skills & Experience
Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field
Minimum of 3 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities
Knowledge of PV principles, systems and requirements in addition to PV regulations
Experience working cross culturally and actively supporting diversity
Computer skill required- use of database and basic Office 365 suite applications
Problem solving, conflict resolution and critical thinking skills
Demonstrated ability to build and manage close relationships with key stakeholders within the region.
Proficient in Good Documentation Practices
Experience interacting with auditors/inspectors
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Requisition ID: R81053
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