Area Safety Lead, Local PV, Australia/New Zealand
Location: Canberra, Australian Capital Territory, Australia
Posted: 1 day ago
This position reports into the Area Safety Head and is based in Sydney, Australia.
Position Summary
The Area Safety Lead is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies / procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.
This role will act as the Local Operating Company (LOC)'s main point of contact for pharmacovigilance matters with the local health authorities and will ensure that appropriate product vigilance and risk management systems are in place to assure oversight of products within its responsibility.
Principal Responsibilities
Act as Local Nominated Person (including backup): Function as nationally nominated person for pharmacovigilance in Australia and New Zealand, ensuring 24/7 availability; collaborate with the QPPV offices as required.
Oversight of the PV System & Overall Responsibilities (20%):
Provide oversight of vendor resources in the countries in scope.
Manage and coach direct reports if applicable.
Act as a delegate for the Area Safety Head when required.
Record self-identified non-conformances and collaborate with the global team to investigate and implement effective CAPAs.
Support the Area Safety Head in providing relevant local information for the EEA/UK Pharmacovigilance System Master Files and meet local PSMF requirements.
Safety Management & Reporting (40%):
Maintain up-to-date knowledge of local pharmacovigilance, cosmetic, and device vigilances and reporting requirements.
Oversee day-to-day adverse drug reaction events inbound and outbound reporting.
Respond to safety-related health authority queries.
Ensure documented training on safety reporting responsibilities for LOC personnel.
Maintain oversight of identification of local literature articles for AE reporting.
Perform regulatory monitoring for impacts on vigilance activities.
Ensure reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
Collaborate with global and local teams to notify authorities of safety issues (SSI/ESI and signals).
Ensure pharmacovigilance compliance of local company-sponsored programs and research activities.
Perform document management and archiving as required.
Provide information to global teams for local activities compliance, case reporting, safety reporting, and risk management plans.
Perform translation for ICSR and PV-related documents, as needed.
Collaboration & Support (15%): Provide technical and strategic input and participate in projects/workstreams led by KMS teams or LOC.
Procedural Document (5%): Maintain local procedures and assess the impact of changes on global procedures.
Audit & Inspection Readiness (5%): Support local health authority inspections and audits, respond to queries, and implement CAPA plans.
PV Contract Management (10%): Manage PV clauses in local agreements.
Business Continuity (5%): Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage).
Other Duties
N/A
Qualifications
Education
Health care science professional (preferably Physician or Pharmacist)
Years of Related Experience
4-6 years of relevant experience.
Knowledge, Skills & Abilities
Pharmaceutical industry experience including product vigilance responsibility role.
Ability to organize workflow activities and manage multiple critical issues.
Experience with vendor resource oversight.
Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
Expert knowledge of global, regional, and local procedural documents as applicable.
Computer literate with knowledge of relevant IT safety systems.
Excellent verbal and written communication skills.
Ability to establish and maintain open relationships within the organization and with authorities.
Demonstrable knowledge of all local requirements and global aspects of product safety.
Fluency in the national language(s) and the English language.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Function
Sales and Business Development
Industries
Pharmaceutical Manufacturing
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