Responsibilities:

1.   Product safety management, and the core job responsibilities may include those listed below: 

   - Study level documents review from PV perspective, e.g., CSP, SAP, CRF, CSR.

   - Product level documents review from PV perspective, e.g., IB.

    - Develop RCP, DSUR, SMP, RMP, etc. or review them when outsourced.

   - Identify and investigate safety signals.

   - Provide PV support on publication, IND and NDA, address HA inquiries where needed.

   - Monitor the relevant safety data from various sources on an ongoing basis.

2. Oversee the PV system and ensure compliance:

    - Maintain the PV system in compliance with the applicable national and international regulatory requirements.

   - Review and provide input to the PVA with Business Partners, where applicable.

   - Provide trainings to CRO on their responsibilities for safety related activities, and manage the CRO performance to ensure their deliverables with high quality and compliance.

   - Develop and update PV relevant SOPs/WIs.

Qualifications:

1. Master’s degree or above in clinical medicine or pharmacy, oncology related therapeutic area is a plus.

2. At least 5 years of pharmacovigilance experience, or overall equivalent experience profile. 2 years or more PV physician work experience preferred.

3.Good knowledge of PV relevant national/international regulations, safety database, signal detection and risk management.

4. Good communication/collaboration skills and team works.

5. Fluent in English (writing and speaking).

Laekna Therapeutics is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.