Local Contact Person for Pharmacovigilance and Regulatory Affairs

About the role

PrimeVigilance is seeking a Local Contact Person to act as the primary liaison for Pharmacovigilance (PV) and Regulatory Affairs (RA) in Australia. The role ensures that all national PV and regulatory requirements are met, supporting the Marketing Authorisation Holder (MAH) throughout the product lifecycle.

Key responsibilities

• Serve as the main point of contact with Australian regulatory authorities for PV and RA matters.
• Collect, translate, and report locally suspected adverse drug reactions (ADRs) and individual case safety reports (ICSRs).
• Provide regulatory intelligence, screening local authority websites and non‑indexed literature for safety information.
• Oversee risk‑minimisation measures, urgent safety restrictions, and emerging safety issues.
• Assist in developing and implementing a local PV system compliant with global and Australian regulations.
• Prepare documentation for regulatory submissions and review local product information.
• Support global RA & PV teams, handle local QA tasks, and participate in audits and inspections.

Required profile

• Bachelor’s degree in Life Sciences or a related field.
• Demonstrated experience in pharmacovigilance and regulatory affairs, preferably within the Australian market.
• Strong understanding of Australian PV legislation and regulatory submission processes.
• Excellent written and verbal communication skills in English.
• Ability to work independently and coordinate with global teams.

Required skills

• Adverse Drug Reaction (ADR) reporting
• Regulatory intelligence screening
• Literature screening for safety signals
• Risk minimisation measures implementation
• Documentation management and preparation for submissions