In today’s pharmaceutical landscape, hiring Drug Safety and Pharmacovigilance (PV) professionals who possess both local and global experience isn’t just a competitive advantage—it’s a necessity. With increased scrutiny from regulators, rapidly evolving global safety standards, and cross-border product distribution, clients must align their pharmacovigilance capabilities with both Therapeutic Goods Administration (TGA) requirements and broader ICH/GVP frameworks.
This article explores why PV professionals with dual exposure—those well-versed in Australian-specific requirements and global regulatory environments—are mission-critical to client success.
1. Dual Compliance Demands: Australia + Global Harmonisation
Clients operating in Australia must adhere to the TGA’s pharmacovigilance standards, including timely submission of ICSRs via the Adverse Event Management System (AEMS), PSUR submissions, and participation in inspections. At the same time, global operations demand alignment with ICH E2E, GVP modules, CIOMS guidelines, and compliance with international agencies such as the FDA and EMA.
2. Efficient Cross-Functional Collaboration
Pharmacovigilance is inherently cross-functional. Whether engaging with clinical development during early-phase trials or aligning with regulatory affairs on post-market submissions, PV talent must speak the language of multiple disciplines across time zones.
Global exposure equips professionals to:
Lead Safety Review Committees with international stakeholders
Align Australia-specific safety narratives with global PSURs and RMPs
Collaborate with CROs, vendors, and global safety teams for signal escalation
Local exposure ensures:
Correct use of the TGA’s case classification logic
Application of safety learnings within the Australian market
Preparedness for site-specific GVP inspections and post-marketing studies
3. Adaptability to System Variations and Data Workflows
Modern pharmacovigilance relies on validated safety databases like Oracle Argus, ArisGlobal, and Veeva Vault. Global PV professionals are often familiar with multiple platforms due to multinational exposure, enabling them to adapt quickly and ensure data integrity across platforms.
At the same time, local experience offers familiarity with:
TGA-specific platforms like AEMS
Regional literature surveillance methods
Domestic adverse event patterns and reporting expectations
4. Strategic Safety Leadership and Decision-Making
PV professionals with global exposure often bring broader perspectives on emerging trends like AI-enabled signal detection, international audit strategies, or implementation of global safety dashboards. These professionals are also equipped to advise on risk-benefit profiles across varied populations and regulatory frameworks.
However, local experience grounds their approach in real-world application. For instance:
Australian reporting timelines for SUSARs and AEs differ from other regions.
Local regulatory expectations for DHPCs (Direct Healthcare Professional Communications) can shape strategic communication.
A candidate with dual exposure doesn’t just process safety data—they help clients navigate complex regulatory terrain and make strategic safety decisions with confidence.
5. Readiness for Global Launches and Inspections
When launching products across regions, companies face variable safety expectations. TGA submission schedules, regional safety studies, and real-time AE monitoring differ significantly between countries.
A PV professional with local-global experience is best positioned to:
Harmonise local and global safety data
Translate Australian PV findings into global reporting systems
Respond confidently during both TGA and global pharmacovigilance inspections
This becomes particularly valuable for companies preparing for simultaneous market entries or regulatory audits across regions.
6. Business Continuity, Risk Reduction, and Compliance Safeguards
Hiring professionals with both local and global PV exposure dramatically reduces onboarding time, compliance risk and business disruptions during audits or product launches.
This talent also ensures seamless handovers between regional affiliates and global headquarters, avoiding data silos and operational inefficiencies that could lead to regulatory penalties.
In 2025, clients can’t afford to choose between TGA fluency and global systems knowledge - they need both. The ideal PV candidate is a hybrid—someone who can process ICSRs under Australian timelines today, participate in EMA-driven signal detection tomorrow, and guide global strategy reviews.