Associate Director, Safety Operations & Data Management Group Lead
Associate Director, Safety Operations & Data Management Group Lead
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Job Description
extranotordinary
Position Summary:
The position is responsible for all the safety case processing and safety data management matters regarding all products in both the development phase and the post-marketing phase. This position leads regional Safety Opes & DM function group and also may act as a deputy safety supervisor (deputy Anseki).
Primary roles & responsibilities include but are not limited to;
Safety operation (case processing) and safety data quality management
Define/develop Safety Operations process and strategies.
Define/develop and maintain required process documents i.e. safety related QMS documents safety monitoring plan etc.
Ensure complying with the local/global regulatory requirements and reporting due date.
Oversight/perform real time/retrospective QC for safety case data entry and scheduled reports.
Oversight/conduct the daily cases monitoring in the safety system workflow.
Oversight SAE Reconciliation activities including review and approval of the reconciliation plan and generation of SAE reconciliation listings.
Ensure/conduct data corrections and case deletions upon request or as needed.
Work with other relevant Genmab departments to standardize the safety reporting process language in documents safety reporting forms according to the local/global reporting requirements.
Provide guidance on questions around safety operations based on not only company conventions but also ICH and regulatory guidance.
Introduction implementation and maintenance for any safety related systems any other computer systems and tools
Lead/facilitate project for safety related systems and tools.
Act as the primary business contact at Drug Safety Japan to IT team and GDS regarding requirement specification system development/implementation plan and validation testing.
Generate required periodic listings or ad-hoc tabulations.
Collaborate with global Safety Opes & DM team regarding study start-up activities MedDRA version up activities.
Oversee appropriate maintenance for required drug codes (J-Drug Code) or company defined code in the company safety system.
Review and/or submit configuration or customization requests for any safety related system.
if could the following roles may be assigned for support to global Safety Opes & DM role.
Perform User Acceptance Test (UAT) on Safety Related Forms in EDC ensuring correct dynamics and edit checks. Provide comments on the e-Safety Reporting Form Specifications document and perform UAT.
Oversight safety CRO activities and coordinate CRO contract/ AE reporting agreement
Ensure/lead vendor selection process and implement outsourcing activities for Safety Opes & DM related topics according to both local/global requirements.
Ensure/Oversight preferable vendor for PV operation activities including the relevant budget management.
Oversight the appropriate case intake of safety reports and case processing due date.
Oversight other activities related to safety operations including ICSR submission or distribution to Regulatory authorities/ECs/IRBs/Investigators/Business Partners.
Escalate/propose appropriately improvement/function growing plan to local head of Drug Safety and required global stakeholders.
Ensure reliability of GVP related activities for case processing and safety compliance.
Have appropriate safety communication and work in collaboration with global counterpart or DS&PV team.
Establish good relationships with global counterparts.
Closely communicate the product status/updates of safety regulations in timely manner from system configuration perspective.
Take appropriate actions to local and global DS for providing the training program on the responsible topics.
Required Technical Skills and Competencies
- Minimum 6 years of relevant experience in Safety Operations or Safety Data Management area
- Experience executing process/projects in own area (e.g. regulations & reporting requirements preparation of post-marketing and clinical safety assessment safety case processing PV data systems and PV report generation)
- Experience guiding team members around complex issues on SDM topics.
- Advanced knowledge of GCP GVP GPSP requirements and relevant global GxPs requirements regulatory compliance and documentation requirements relevant for scope of work.
- Sufficient knowledge of ICH E2B(R2) and (R3) specifications and entry guidance.
- Sufficient knowledge of compliance relevant regulatory obligations especially pharmacovigilance reporting rules and timelines.
- Experience with clinical and post-marketing case processing including MedDRA and required drug dictionary coding and narrative writing
- Experience close collaboration with other departments in local and global including license partners.
- Must have strong English capability to communicate with global stakeholders effectively (intermediate business communication level or above)
- Bring out-of-box thinking and will to make it happen
Optional Experience & Skills:
- Experience of leading projects on safety system release/significant upgrades in globally or locally.
- Experience of people management.
- Knowledge and experiences of ARGUS safety system and/or any other Safety systems
- Knowledge of ERES (Electrical Records Electrical Signature) / e-documentation requirements
- Re-examination experiences (ICSR case processing part in the inspection or Response to PMDA queries)
- Clinical (Study) data management experience or EDC for clinical trial data collection experience.
- Clinical operation / monitoring experience
- Experiences of activities related to Pharmaceutical Manufacturing/Marketing Company License (Gyokyoka)The Initial License Registration () The renewal of License ().
25Tbispecific T-cell engagersADC
2030
1999
Required Experience:
Director
Employment Type
Full-Time
