Position Summary:

The position is responsible for all the case processing and safety data management matters related to pharmacovigilance area activities for products both in development phase and in post-marketing phase.

Primary roles & responsibilities include, but are not limited to;

Case processing and safety data quality management in both development phase and post-marketing phase.

Comply with the regulatory requirements and reporting due date.

Perform inline approval review of safety case data entry and confirmation on scheduled reports (not only PMDA report but also other reports to regulatory authorities or business partners).

Case assessment (causality, seriousness, expectedness, coding, reportability)

Case query process including sending follow up letter to Sales reps, communication with Sales reps or other stakeholders and query due date management.

Daily monitoring of cases in the Argus system workflow and submissions.

Conduct data corrections and case deletions upon request or as needed.

Develop and maintain required process documents i.e. safety related QMS documents, safety monitoring plan

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 and training around safety operations based on not only company conventions, but also ICH and regulatory guidance.

Oversee and manage SAE Reconciliation activities including review and approval of the reconciliation plan and generation of SAE reconciliation listings.

+ if could, the following roles may be assigned for support to global Safety Ops&DM role.

CREATE documentation to perform tests e.g., test scenarios, for safety system related projects. Perform formal test i.e., User Acceptance Test (UAT) as well as informal test (development environment) on Safety system Related projects.

Contribute to introduction, implementation and maintenance for any safety related systems and tools

Contribute to the effort of selection/implementation of Drug safety solutions in collaboration with Global Drug Safety (GDS) responsible person for Japan regulatory requirements perspective.

Implement and manage safety related systems and tools. Act as one of business contacts at Drug Safety Japan to IT team and GDS regarding configuration, requirement specification, system development/implementation plan and validation testing.

Generate required periodic listings or ad-hoc tabulations.

Support to global Safety Ops&DM team regarding study start-up activities, MedDRA version up activities.

Monitor and maintain required drug codes (J-Drug Code) or company defined code in Argus safety system.

Review and/or submit configuration or customization requests for safety systems.

Oversight safety CRO activities and coordinate contract/agreement process

Contribute to the appropriate vendor selection and implementation for outsourcing activities regarding Safety Ops&DM responsible activities for local requirements and keeping consistency with global process.

Contribute to assessment and proposal for preferable vendor in PV operation activities and required quality/compliance including the relevant budget management.

Oversee the successful and timely case intake of safety reports and case processing according to supervisor's direction or company requirements.

Oversee other activities related safety operations including ICSR submission or distribution to Regulatory authorities/ECs/IRBs/Investigators/Business Partners according to supervisor's direction or company requirements.

Propose appropriate improvement/function growing plan to local head of Drug Safety through daily activities or lessens/learning.

Contribute to 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 relationship 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.

• Must have minimum 2+ years' Safety Operations experiences with high agility to learn and grow.
• Sufficient 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.
• Must have positive intention regarding the Safety Data Management area
• Experience with clinical and post-marketing case processing, including MedDRA and required drug dictionary coding and narrative writing
• 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

• 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 of global projects as a member at least in collaboration with global employees in the other regions for safety system release/significant upgrades.
• Knowledge and experiences of ARGUS safety system
• Knowledge of ERES (Electrical Records Electrical Signature) / e-documentation requirements
• Experience close collaboration with other departments in local and global including license partners.
• 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 (気加把人起試總とした待を会), The renewal of License (気加把人起試總とした待を会).
• Valid working visa or permanent residency in Japan.
• Native level Japanese in verbal, reading, & writing.