Regional PV Manager

Rxilient is seeking an experienced Regional Pharmacovigilance (PV) Manager to establish and maintain the company's regional PV system. This role is critical in ensuring compliance with applicable global and local pharmacovigilance regulations across all markets in Asia-Pacific and middle eastern countries.

The ideal candidate will have solid experience managing operational PV systems, oversight of case processing KPIs, ICSR submissions, reconciliation activities, and ensuring inspection readiness

Primary Duties & Responsibilities:

• Establish and maintain an efficient and compliant PV system across the region, including Singapore, Southeast Asian countries, and Middle East.

• Ensure compliance with local and global PV regulations and internal standards.

• Oversee adverse event case management for both global and local products, including timely reporting to affiliates, regulatory authorities, and business partners.

• Supervise literature screening processes for identification of reportable adverse events or safety concerns.

• Provide oversight for signal detection, safety data analysis, risk-benefit assessments, and input into Risk Management Plans (RMPs), PSURs/PBRERs, DSURs, and other aggregate reports.

• Maintain and regularly update Standard Operating Procedures (SOPs), Work Instructions (WIs), and other PV-related quality documents.

• Manage and oversee Pharmacovigilance Agreements (e.g., Safety Data Exchange Agreements – SDEAs) with business partners.

• Ensure timely reconciliation of safety data across business partners, affiliates, and internal departments.

• Maintain and oversee the Pharmacovigilance System Master File (PSMF).

• Support internal audits and external inspections; coordinate CAPA management and implementation.

• Act as the PV Point of Contact (POC) for commercial teams, market research, patient support programs, and third-party vendors regarding PV obligations and AE/PQC training.

• Monitor safety inboxes and ensure triage procedures are robust and timely.

• Develop, maintain, and track ICSR reconciliation logs across various sources (e.g., EAP, PSP, digital channels, social media)

Job Specification:

• Bachelor's or Master's degree in pharmacy, medicine or nursing, biology or life sciences, or a related scientific or healthcare discipline.

• Minimum 8 years of experience in Pharmacovigilance with Bachelor's degree, or minimum of 6 years of experience in PV with Master's degree, from the pharmaceutical, biotech, or CRO environment.

• In-depth knowledge of global and regional PV regulations (e.g., FDA, EMA, CDE, Asia-pacific region).

• Strong experience in ICSR case processing, MedDRA/WHO-DD coding, and narrative writing.

• Experience with safety systems/databases (e.g., Argus, ARISg).

• Familiarity with aggregate report writing, signal detection, risk management plans, and regulatory submissions.

• Experience working with regional health authorities and external partners in Asia-Pacific is preferred.

• Excellent leadership skills, strong judgment, decision-making, planning and execution skills, good professional ethics and dedication and diligence

• Familiar with various pharmaceutical regulations, drug management regulations and customer requirements

• Proficiency with safety databases (e.g., Argus, ARISg) and electronic reporting tools.

• Strong attention to detail and high degree of accuracy in safety documentation.

• Good understanding of medical terminology and safety data coding (e.g., MedDRA, WHO-DD).

• Excellent communication and cross-functional collaboration skills.

• Detail-oriented, analytical, and quality-driven.

• Experience with automation tools (AI tools in PV) is a plus.

• Fluent in English and Chinese (written and spoken)