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Manager, Pharmacovigilance&Epi

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Essential duties and responsibilities include, but are not limited to the following:

Ensuring that local safety data and report operations system is conducted in compliance with regulatory and internal company standards as set out within applicable regulations or guidance and global or local Procedural Documents (PDs).

Managing all aspects of local Individual Case Safety Report (ICSR) Management:

  • Collecting, recording, processing, translating and submitting AEs and special situation reports (SSRs) from all sources to PVE (including reports from local literature, websites and solicited programmes) in compliance with corporate requirements and local regulations.
  • Conducting appropriate and timely follow-up on all ICSRs, including use of targeted questionnaires.
  • Screening of local literature (where not covered in the global search) for Adverse Drug Reactions, SSRs or other relevant safety data on a weekly basis or according to journal publications.
  • Recording and maintaining ICSR data (including the management of follow-up) in the Local Affiliate Module of the global safety database (LAM).
  • Ensuring that appropriate ICSRs are notified to the local Regulatory Authority in a timely manner and in accordance with corporate and regulatory requirements where applicable and recorded in LAM.

Managing aspects of Aggregate Safety Report Management:

  • Supporting PRP to prepare the local PSUR/PBRER submission schedule
  • Coordinating with related functions to complete local PSUR/PBRER submission to regulatory authority
  • Ensuring the foreign SADR reporting submission to regulatory authority in compliance with local regulation and company process
  • Ensuring the compliance and quality of aggregate safety reports management.

Maintaining local knowledge in relation to:

  • the Gilead Pharmacovigilance organization
  • local Regulatory Authority contacts and local Pharmacovigilance regulatory requirements (and communicating changes in requirements to PVE), specifically for submission of safety reports including PBRER/PSURs and creation of local Pharmacovigilance plans.
  • studies and solicited programmes on going in their region,
  • marketed status of Gilead products in the local country,
  • local licensing agreements (if applicable)
  • safety related issues and forwarding any information that may be of relevance to the identification of potential safety signals to PVE / EU QPPV and local senior management.

Supporting PRP to oversee the local Quality Management System:

  • Training Affiliate staff on safety reporting procedures including the timely reporting of safety information to PVE / PRP e.g. new hire training, sales and solicited programs training and ensuring all training is documented.
  • Maintaining knowledge of global PDs as they pertain to Affiliate and support PRP to ensure that local PDs, including a Business Continuity Plan (BCP) are in place for specific local processes that are not covered by a global PD.
  • Ensuring an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented.
  • Reviewing the monthly global compliance reports produced by DPSH and taking necessary corrective actions locally as applicable.
  • Performing applicable quality checks of local cases before routing, Regulatory Authority submissions and review of medical information enquiries.
  • Ensuring archiving of safety data in accordance with the Gilead’s retention policy and national requirements.
  • Recognizing the need for and seeking assistance from appropriate internal and external resources in the area of responsibility, with ability to recommend or clarify requirements/solutions.
  • Highlighting areas of concern to manager; able to make recommendations for improvement.
  • Providing regular updates to manager, including challenges and suggested actions that could be taken.
  • Supporting RPR on local service provider management.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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