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.
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.
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.
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