Mirum Pharmaceuticals
Senior Manager, Medical Safety Operations
Mirum Pharmaceuticals, Foster City, California, United States, 94420
POSTION SUMMARY
The Senior Manager in Medical Safety Operations will support pharmacovigilance (PV) agreement maintenance, compliance oversight, and vendor oversight activities with respect to the individual case safety report (ICSR) processes at Mirum. This role collaborates with cross functional teams, vendors, and partners/distributors.
JOB FUNCTIONS/RESPONSIBILITIES
Develop PV agreements with license partners, distributors, and relevant parties to document the appropriate safety data exchange commitments. Update PV agreements, if needed.
Oversee compliance as it pertains to safety data exchange commitments with license partners, distributors, and relevant parties.
Oversee and manage PV vendor to ensure ICSR management is compliant with documented procedures as well as regulatory requirements. This includes ICSR quality oversight and submission compliance oversight.
Lead and address quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions management related to PV processes.
Conduct quarterly ICSR forecast to ensure resources allocated by the PV vendor and internal Medical Safety staff are sufficient.
Support data migration and map ICSR processes for new products, as needed.
Support post-market programs on an as needed basis.
Support audits and regulatory inspections.
QUALIFICATIONS
Education/Experience:
Minimum of 6 years direct pharmaceutical industry experience supporting global clinical study and post-market safety processing and reporting.
Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety.
Knowledge, Skills and Abilities:
Bachelor’s degree in life sciences, MD, PhD, PharmD, BSN/RN preferred.
Safety database experience is required.
PV quality management experience is preferred.
Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools.
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The Senior Manager in Medical Safety Operations will support pharmacovigilance (PV) agreement maintenance, compliance oversight, and vendor oversight activities with respect to the individual case safety report (ICSR) processes at Mirum. This role collaborates with cross functional teams, vendors, and partners/distributors.
JOB FUNCTIONS/RESPONSIBILITIES
Develop PV agreements with license partners, distributors, and relevant parties to document the appropriate safety data exchange commitments. Update PV agreements, if needed.
Oversee compliance as it pertains to safety data exchange commitments with license partners, distributors, and relevant parties.
Oversee and manage PV vendor to ensure ICSR management is compliant with documented procedures as well as regulatory requirements. This includes ICSR quality oversight and submission compliance oversight.
Lead and address quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions management related to PV processes.
Conduct quarterly ICSR forecast to ensure resources allocated by the PV vendor and internal Medical Safety staff are sufficient.
Support data migration and map ICSR processes for new products, as needed.
Support post-market programs on an as needed basis.
Support audits and regulatory inspections.
QUALIFICATIONS
Education/Experience:
Minimum of 6 years direct pharmaceutical industry experience supporting global clinical study and post-market safety processing and reporting.
Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety.
Knowledge, Skills and Abilities:
Bachelor’s degree in life sciences, MD, PhD, PharmD, BSN/RN preferred.
Safety database experience is required.
PV quality management experience is preferred.
Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools.
#LI-Onsite
#J-18808-Ljbffr