Senior Manager / Associate Director / Director, Pharmacovigilance (PV)

Position Overview

SanegeneBio is a global, venture-backed, clinical stage biotech company advancing best-in-class genetic medicines. We are 70+ employees with a single vision: unlocking the full potential of RNAi-powered medicines for metabolic and autoimmune diseases. With our corporate headquarters and platform research center in the Boston area, as well as R&D and clinical operations in China, SanegeneBio is well-positioned to develop innovative oligonucleotide therapeutics and change lives. Our LEAD™ siRNA delivery and chemistry platform enables systemic delivery to tissues and cell types of therapeutic relevance with a strong selectivity, tolerability, potency and duration of action profile. Our Core Values foster cross-functional collaboration, continuous learning, scientific rigor, and an enduring spirit of optimism.

SanegeneBio is currently seeking an experienced Pharmacovigilance (PV) professional at the Manager to Director level to establish, manage, and execute the company’s full safety and PV operations. This is a hands-on role suitable for highly motivated candidates who can independently lead PV compliance, case management, vendor oversight, and safety strategy across the pipeline. The successful candidate will serve as the primary owner of the company’s Safety Management System (SMS) and ensure global regulatory compliance. Title level (Manager / Senior Manager / Associate Director / Director) will be determined based on experience and qualifications. Title and level (Manager → Director) will be based on experience, medical background, and leadership capabilities.

Key Responsibilities

1. PV System Setup & Oversight: 1) Serve as the company-wide subject-matter expert for pharmacovigilance. 2) Develop, implement, and maintain the Safety Management System (SMS), PV procedures, and compliance structure. 3) Ensure adherence to global PV regulations (FDA, EMA, ICH, NMPA, etc.).
2. Case Processing & Safety Operations: 1) Oversee complete end-to-end safety case processing via internal teams or external vendors. 2) Review SAE cases, narratives, MedDRA coding, seriousness assessment, and follow-up quality. 3) Ensure timely reporting of SAEs/SUSARs to regulatory authorities and stakeholders.
3. CRO & Vendor Management: 1) Manage PV vendors, CROs, and safety service providers. 2) Monitor deliverables, KPIs, quality, and timelines. 3) Review scopes of work, contracts, and compliance expectations.
4. Clinical Trial Safety Support: 1) Provide PV input for protocols, ICFs, IBs, DSURs, CSR safety sections, and other documents. 2) Participate in study startup activities, safety review meetings, and safety committees. 3) Support evaluation of emerging safety data and signal detection.
5. Safety Surveillance & Risk Management: 1) Conduct routine and proactive safety surveillance and signal detection. 2) Support development of Risk Management Plans (RMPs) and benefit–risk assessments. 3) Maintain safety tracking tools and ensure audit/inspection readiness.
6. Regulatory Support: 1) Prepare or contribute to safety-related regulatory submissions and responses. 2) Participate in regulatory interactions related to PV responsibilities.
7. Cross-functional Collaboration: 1) Collaborate closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external partners. 2) Provide internal PV training and guidance when needed.

Qualifications

1. Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related field.
2. 6+ years of hands-on pharmacovigilance experience in pharma/biotech.
3. Strong knowledge of global GVP/ICH safety regulations.
4. Experience with clinical safety, case management, and vendor oversight.
5. Ability to independently operate as a one-person PV function.
6. Strong communication, documentation, and project management skills.
7. Preferred: 1) MD or medically qualified background strongly preferred, particularly for medical evaluation and safety review. 2) Familiarity with safety databases (Argus, ArisGlobal, Veeva Safety, etc.). 3) Experience in rare disease, biologics, gene therapy, or other innovative modalities.

Interested candidates: please send your information to hr@sanegenebio.com.