27 days old

Patient Safety Specialist (Manager)

52446
Patient Safety Specialist (Manager)
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Purpose

The purpose of the Senior Product Safety/ Senior Pharmacovigilance (PhV) Associate, or Product Safety/ PhV Associate is to manage adverse event reporting in the affiliate; ensure regulatory compliance for expedited and periodic submission of safety reports; collaborate with internal and external customers to ensure safety reporting process is established; provide support to global personnel regarding Global Patient Safety (GPS) procedures and processes.

Key Responsibilities

  1. Case management -Collection of adverse events (AE) information(Including initial and follow up), and case entry into Local Affiliate Module (LAM) of Lilly Safety System (LSS)
  • Responsible for basic understanding of adverse event management and workflow elements as per regional/global SOP and local job aids.
  • Review cases reported by the reporters, and perform case entry into LAM within the required timeline.
  • Perform quality review of cases.
  • Conduct local literature searches for reportable AE in accordance with local regulatory requirements and local process, as applicable.
  1. Expedited and Periodic Reporting
  • Review all cases reported to establish need to report to local authorities in accordance with local regulations and internal procedures.
  • Perform expedited and periodic reporting to the local regulatory authority within the required timeline.
  • Monitor changes in local safety regulation and communications to local regulatory authorities on safety issues, as required.
  1. Maintenance of Pharmacovigilance Quality and Works
  • Responsible for interacting with local functions (e.g. Regulatory, Product Complaint, Medical Information Services, Medical/Clinical, Sales, Patient Support Program/Call Centre, Market Research) to ensure all AEs received from local functions are reported to Global Patient Safety (GPS) in a timely manner.
  • Responsible for escalating patient safety issue to local PhV management and GPS, as appropriate.
  • Maintenance of a local PhV Quality System (update of local SOP/Job aid) to support safety, as appropriate.
  • Provide update on PhV compliance metrics to GPS on a timely basis.
  • Ensure completion of action items of GPS Quality Plan, Corrective, and Preventative Action (CAPA) within the required timeline.
  1. Pharmacovigilance Training and Support
  • Provide affiliate training on AE reporting for affiliate employees.
  • Provide PhV information and/or training to external customers, as appropriate.
  • Provide support to affiliates ensuring local agreements containing adverse event reporting requirements for local business alliances and for third parties that may receive adverse event reports due to the nature of their services.
  1. Others
  • To have understanding on the roles and responsibilities of the EU Qualified Person.

52446BR

Minimum Qualification Requirements

  • Education: Bachelor's degree (or higher) in a health care-related or life science field (i.e. Pharmacy, Nursing) or equivalent
  • Effective communication skills to interact with diverse groups and individuals
  • Basic computer skills (Microsoft Word, Excel, Windows XP)
  • English language skills - written and verbal

Other information/additional preferences:

  • Knowledge of global regulations with respect to adverse event reporting
  • Knowledge and understanding of Global Patient Safety procedures and processes
  • LAM/LSS experience (case entry and processing for expedited reporting, as appropriate)
  • Patient/Drug safety experience
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Categories

Industry

  • Science
Posted: 2019-09-16 Expires: 2019-11-11

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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Patient Safety Specialist (Manager)

Lilly
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