Reporting to the PV Head of Department, this role acts as lead for the execution of local (in country) pharmacovigilance activities aligned with the global pharmacovigilance function.

Implement safety measures for pre- and post-marketing Mundi products based on local regulations to keep risk and benefit balance appropriately.

With the head of department drives efficient management and delivery of all aspects of local operational activities.

Key Responsibility

1. Responsible for management and oversight of the local vendor responsible for executing operational activities including but not limited to:

• Case management
• Local Literature monitoring
• PV training
• Resolving issues inquiries about ICSR from PMDA

Responsible for monitoring compliance and performance metrics and monitors quality and timely delivery of safety outputs by the vendor

2. Work with the vendor and Central Safety evaluation team to prepare periodic safety reports with PMS responsible person and Department head

3. Collaborates with the Central Safety Systems team in maintaining a single global safety database, specifically the Argus J module

4. Implement safety measures with Japan PV head to assure patient’s safety

5. Maintain local RMP appropriately to reduce safety concerns of Mundipharma products

6. Implementation and oversight activities of local RMP, including additional pharmacovigilance activities such as:

• Early Post-Marketing Phase Vigilance (EPPV)
• Post Marketing Surveillance (PMS)
• Additional Risk Minimisation Measures (aRMMs)

7. Tracking and preparation of local periodic/aggregate safety reports

8. Planning and execution of Mundipharma product re-examination activities

9. A member of safety team supporting the organization in fulfilling global pharmacovigilance requirements.

• Responsible for escalating issues related to department head, safety cluster lead, Director of Local Safety Operations or EEA QPPV, where appropriate.

Drives efficient and effective delivery of PV Operational activities.

10. Act as the contact person for audits/Inspections and ensures inspection and audit readiness for PV operational matters

Works with Local and Central Quality Assurance (QA) to maintain an inspection readiness state.

Qualifications

Minimum Required Education:

Bachelor’s degree of faculty of science and technology

Preferred Education:
Master’s degree of faculty of science and technology

Experience:

Work experience in PV department of pharmaceutical companies or PV service providers more than 3 years

Knowledge and Skills:

·   Enough knowledge of GVP, GPSP, and GCP

·   English language proficiency (business discussions, reading, and writing)

·   Ability to write and edit business process documents (e.g. SOPs, working instructions)

·   Strong communication skill

·   Computers: basic IT skill

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