Organon Hiring Senior Specialist, Pharmacovigilance Systems Configuration

Organon Hiring Senior Specialist, Pharmacovigilance Systems Configuration

14 April, 2022

Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it!

The Senior Specialist, PV Systems Configuration, ensures current configurations of all PV systems used by the Global Pharmacovigilance & Safety Science department. The incumbent will collaborate with Business Technology and other PV functional leads to deliver an efficient and compliant PV system.

Organizational Relationships

  • Level: Senior Specialist
  • Reports to: Associate Director, PV Systems Configuration
  • Direct Reports: No
  • Collaborate with internal and external business functional leads to ensure completion of assigned responsibilities

Primary Responsibilities

  • Drive completion of all Product Licenses Study Reporting (PLSR) configurations
  • Manage change request for new or existing changes to reportability rules
  • Collaborate with PV intelligence and Local PV leads to identify new or changes to regulations which require
  • Collaborate with other PV functional leads to ensure business requirements are being met
  • changes in configuration of the safety database
  • Configure changes to product data in the safety database upon approval or withdrawal of products
  • Process requests for submission assessment reports
  • Drive completion of MedDRA/WHODD updates to the safety database
  • Monitor company product list to assess impact to safety database and process updates accordingly
  • Support in executing User Acceptance Testing (UAT)
  • Collaborate with Business Technology to ensure a viable Disaster Recovery Plan and Business Continuity Plan for PV Systems is in place
  • Communicate relevant systems communications with respective users
  • Provide support to those activities essential to supporting updates and maintenance of the safety database
  • Participate and support in various important pharmacovigilance processes, IT and quality initiatives contributing to continuous process improvement of ICSR management and innovative solutions
  • Collaborates internally and externally on processes that ensure compliance with local and global PV regulations
  • Participate in inspection readiness activities and preparation as needed

Education Minimum Requirements

  • Bachelor’s degree or master’s degree in a life science/health care/computer science related field

Required Experience Requirements

  • Minimum of 2 years of experience in the pharmaceutical industry; specific focus on pharmacovigilance systems configuration and database maintenance related activities is a plus
  • Knowledge of PV principals, systems and requirements in addition to relevant PV regulations
  • Experience working cross culturally and actively supporting diversity
  • Computer skills required: Use of pharmacovigilance database and basic Office 365 suite applications; programming knowledge is a plus
  • Problem solving, conflict resolution and critical thinking skills
  • Excellent presentation, writing and communication skills
  • Excellent written and spoken English
  • Demonstrated ability to build and manage close relationships with key stakeholders within the region Proficient in Good Documentation Practices
  • Experience interacting with auditors/inspectors

Apply through this Link


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