Pharmacovigilance (PV) Manager/Sr. Manager
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective, and lower-risk drug development in international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com
The Pharmacovigilance Senior Manager/Manager will play a key role in Global drug safety operations across the clinical development programs and post marketed programs. The PV Sr. Manager/Manager will contribute to the day-to-day operational activities of the Global safety and Pharmacovigilance functions within the Product Development departments and ensures that performed tasks comply with the standard operating procedures and the applicable regulations.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYABIO functional areas and its global office sites is essential.
Primary Duties and Responsibilities
- Help maintain the global safety database
- Assist in administration of PV meetings through meeting agenda, minutes, and organization as delegated.
- Liaise with PV vendor and helps track safety (individual and aggregate) and case data including (but not limited to) to the following activities:
- Track safety data captured in the safety database (including SAE, pregnancy, overdose).
- Reconciliation with the clinical data captured in the clinical database.
- Archive Safety & Pharmacovigilance documents accurately and in a timely manner.
- Support Safety & Pharmacovigilance with drafting agendas and meeting minutes, and with various ad hoc deliverables or projects as needed.
- Review safety case data, adverse event coding review, line listings, and other Safety and Pharmacovigilance documents for accuracy and completeness for aggregate reports such as DSUR/PBRER.
- Maintain vendor compliance metrics.
- Participate in audits and support inspection readiness activities.
- Support in the revisions of SOPs, Safety data exchange agreements, maintenance of PV contracts with vendor.
Job Qualifications and Requirements
- Good working knowledge of drug safety databases (preferably ARGUS) and MedDRA.
- Knowledge of FDA and EU, ICH adverse event reporting regulations and the ability apply applicable regulations to maintain compliance.
- Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
- Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.
Education and Experience
- RN or Master's degree in a relevant field.
- 3 to 5 years of Pharmacovigilance and/or Biopharmaceuticals industry.
The position is full‐time, and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters.