Position Title: Sr. Manager / Associate Director, PV Compliance
Function: Clinical Development - PV
Report To: Head of PV
Entity: Laekna Therapeutics
Provide the safety support to assigned clinical projects in all phases of clinical development. Oversee the pharmacovigilance (PV) system and ensure all the PV related activities in compliance with the relevant national and international regulatory requirements and PV agreements.
- 1. 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 PV consultancy and regulation expertise to stakeholders to meet required compliance maintenance.
- ● Provide trainings to CRO on their responsibilities for safety related activities.
- ● Screen and keep alert of national regulation updated/newly released and share with team.
- ● Develop and update PV relevant SOPs/WIs.
- ● Work with relevant colleagues to investigate and resolve non-compliance, deviation and process related issues.
- ● Maintenance of Argus configuration.
- 2. PV vendor management
- ● Manage the CRO performance to ensure their deliverables with high quality and compliance.
- ● To archive all source documentation in accordance with standard operating procedures.
- ● Participate in the PV vendor selection activities if necessary.
- 3. PV inspection/audit
- ●Maintain the internal audit plan and perform GVP related audit.
- ●Lead the PV inspection/audit activities if applicable.
- 1. Bachelor’s degree or above in clinical medicine, biology, or pharmacy, clinical medicine background is a plus.
- 2. At least 5 years of pharmacovigilance experience. Prior experience on PV QA is preferred.
- 3. Good knowledge of PV relevant national/international regulations, GVP, GCP, safety database, management. PV audit /inspection experience is a plus.
- 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.