International Pharmacovigilance Senior Manager (APAC)

TL;DR

International Pharmacovigilance Senior Manager (APAC): Managing and implementing PV systems to ensure regulatory compliance across APAC with a specific emphasis on China. Focus on leading regulatory assessments, developing SOPs, and overseeing safety governance in partnership with local representatives and health authorities.

Location: Sydney, Australia. Role is remote-eligible with hybrid and on-site options available.

Company

hirify.global is a global biotechnology company dedicated to scientific innovation.

What you will do

• Ensure all PV activities and GPS procedures comply with global and local regulations.
• Lead the assessment of regulatory changes in China and APAC to determine system impacts.
• Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Advise leadership on APAC and China-specific regulatory risks and mitigation strategies.
• Oversee PV activities performed by local representatives, affiliates, and service providers.
• Support preparation and responses for China health authority inspections.

Requirements

• Excellent written and oral communication skills in English and Chinese.
• Extensive experience with China PV and local execution practices.
• Strong understanding of China GVP and NMPA expectations.
• B.S. degree with 7-8 years or Advanced degree with 6-7 years of relevant pharmaceutical drug safety experience.
• Proven ability to work with local PV representatives and service providers in China.

Culture & Benefits

• Flexible work arrangements including remote, hybrid, and on-site options.
• Commitment to equal employment opportunity and non-discrimination.
• Global environment focused on scientific innovation and patient safety.
• Supportive infrastructure for professional growth and regulatory excellence.