POSITION SUMMARY:
The Associate Regional PV Manager (PV Systems & Standards) serves as the central governance lead for operational compliance across the APAC region. This role provides strategic and technical expertise to 12 Local Drug Safety Units (LDSUs), driving the integrity of PV deliverables and documentation. Operating with high autonomy, the incumbent ensures that drug/device safety systems and training frameworks remain strictly aligned with global standards and regional mandates.
KEY RESPONSIBILITIES:
PV System Support & KPI Management
- KPI Management: Implement and track PV Key Performance Indicators (KPIs) for the region and LDSUs to ensure compliance targets are met.
- PSMF & Systems: Support PV Quality Assurance in the maintenance and oversight of the EU and Local Pharmacovigilance System Master File (PSMF) as well as related computer systems
- Support deviation, audit (audit planning, execution, report) and CAPA management (both at region and LDSU level).
Compliance Oversight & Training
- Literature Screening: Ensure routine literature screening is performed and documented to identify potential safety concerns across all APAC countries.
- Training Coordination: Manage the PV training matrix, ensuring induction training and annual refreshers are completed and recorded across the region.
PV Aggregate Report & Operational Activities
- Provides input and oversight of PV activities and monthly reconciliation activities in e-commerce, social media, real world evidence projects, clinical studies, market research and patient support programs including surveys
- Ensure compliance and oversight of activities such as aggregate safety reports (RMPs, PSURs, PBRER, DSURs, LL, etc.), product safety labeling, and implementation, and authoring of expert advice and statements with the help of IDSCUM, IDSCUM Deputy and cross-functional teams.
- Participate in and contribute to cross-functional meetings with stakeholders (e.g. Medical Affairs, Regulatory Affairs, Quality Assurance, and Compliance) and ensure the escalation of relevant PV information (e.g. global, regional, cross-functional stakeholders and business partners)
Health Authority Website Monitoring and Regulatory Intelligence
- Advisory: Serve as the Subject Matter Expert (SME) for PV regulations during internal audits and external inspections.
- Active Monitoring: Oversee and perform routine, systematic screening of global Health Authority (HA) websites, industry associations, and legal databases for updates to PV regulations, guidelines, and circulars.
- Intelligence Analysis: Translate complex regulatory language into actionable business insights. Determine how new requirements (e.g., GVP updates, ICH E2B R3 transitions) affect current workflows
- Inspection Readiness: Monitor HA inspection trends (e.g., EMA inspection findings and APAC audits) across the industry to proactively identify and mitigate gaps in the internal PV system.
- Intelligence Database: Maintain the internal Regulatory Intelligence database or tracking matrix to ensure full traceability from Alert to Implementation.
- Intelligence Analysis: Translate complex regulatory language into actionable business insights. Determine how new requirements (e.g., GVP updates, ICH E2B R3 transitions) affect current PV workflows in APAC.
KEY REQUIREMENTS
- Bachelor's or Master's degree in Pharmacy, Nursing, or a Life Sciences related field.
- At least 3 years in Pharmacovigilance within a pharmaceutical organization.
- Proficiency in PV databases (Argus/ArisG) and Regulatory Intelligence platforms (e.g., Cortellis, RegCheck).
- Extensive knowledge of ICH GVP guidelines and APAC PV regulations, with the ability to interpret and operationalize complex regional safety requirements.
- Proficient in Learning Management Systems (LMS) with proven experience designing and delivering PV induction and mandatory annual PV refresher training.
- Practical experience maintaining the EU Pharmacovigilance System Master File (PSMF) and Local Site Master Files (LSMF) to ensure global inspection readiness.
- Highly proficient in Microsoft Excel, Word, and PowerPoint for data tracking and report generation.
- Strong attention to detail, excellent technical writing skills, high level of independence and the ability to influence cross-functional leaders without direct authority.
- Willingness to travel within Asia Pacific as required (typically <25 %).
About Menarini Asia-Pacific
We are a global, family-owned healthcare company where our people are our priority. Present across 13 markets in Asia-Pacific, here's why you should join us:
- Local Market Expertise, Global Footprint: As a global family-owned company, we value local knowledge and expertise to invigorate the lives of patients, people and partners
- Inclusive Flexible Workplace: We are committed to foster a culture of respect and inclusive teamwork to ensure equal opportunities in a flexible workplace
- Versatile Learning and Vibrant Opportunities: Our diverse portfolio of products in varied therapeutic areas across prescription and consumer health presents opportunities for you to take ownership of your career
- Empowered to be Entrepreneurial: We operate in a dynamic, low-bureaucracy environment where swift decision-making allows us to make a real impact
- Sustainability and Care: Be part of a company that cares. Together, commit to sustainable workplaces
Join us and invigorate lives! For more information about Menarini Asia-Pacific, please visit www.menariniapac.com.
