Drug Safety Specialist
Roche
Taipei,Taipei City,Taiwan,
5小时前
  • Job facts
  • Management of Individual Case Safety Report (ICSR) from all relevant sources

  • Ensure all potential ICSRs received from all sources are processed in a timely manner according to global Roche requirements.
  • Ensure diligent follow-up attempts to collect all necessary information for case completeness according to global Roche requirements.
  • Ensure the submission of ICSRs to the local competent authority in a timely manner according to current local regulatory requirements.
  • Ensure adequate documentation and archiving of all drug safety information and corresponding activities.
  • Oversight of Risk Management Plan Implementation

  • Contribute to preparation of local RMP and relevant materials in collaboration with relevant staff in accordance with global Roche and local regulatory authority requirements.
  • Safety Communication

  • Ensure that safety queries are managed according to global Roche and local regulatory authority requirements.
  • Bring potential safety issues / crisis to the attention of line manager in a timely manner.
  • Contribute to preparation of Direct Healthcare Professional Communication (DHPC), Dear Investigator Letter (DIL) and To Whom It May Concern Letter (TWIMCL).
  • Study and Program Oversight

  • Maintain the knowledge of global Roche and local regulatory authority requirements regarding the safety reporting for global and local interventional clinical trials, Non-Interventional Studies (NISs), Market Research and Patient Support Programs (MAPs) and Compassionate Use.
  • Management of Aggregate Reports

  • Provide safety related information to global teams for the preparation of Aggregate Reports, when necessary
  • Prepare local Aggregate Reports in collaboration with Local Regulatory Affairs
  • Ensure submission of PSURs / PBRERs and DSURs / SSRs (as applicable) to local regulatory authorities in accordance with global Roche and local regulatory authority requirements.
  • PV Quality

  • Provide safety related education and training to relevant internal and external stakeholders.
  • Local PV Agreements

  • Prepare local PV agreements in accordance with global templates.
  • Labeling and PV Commitments

  • Assist review of local safety label updates.
  • Who we are At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups.
  • Our success is built on innovation, curiosity and diversity.

    Roche is an equal opportunity employer.

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