Local Contact Person – Pharmacovigilance and Regulatory Affairs
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Local pharmacovigilance and regulatory affairs specialist supporting PrimeVigilance’s pharmaceutical clients. Managing ADR reporting, regulatory submissions, compliance, audits, and local safety requirements.
Responsibilities:
- Act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA)
- Serve as the primary local RA&PV representative to ensure compliance with national pharmacovigilance and regulatory requirements in Australia
- Execute pharmacovigilance and regulatory affairs activities at the local level
- Support the Marketing Authorisation Holder in maintaining product compliance throughout its lifecycle
- Communicate promptly and effectively with the MAH and local regulatory authorities
- Act as primary contact with local regulatory authorities for Regulatory Affairs and Pharmacovigilance
- Provide local regulatory intelligence screening and expert advice for responsible regions
- Collect and report locally suspected ADRs or ICSRs, including follow-ups and translations
- Manage or oversee risk minimization measures related to urgent safety restrictions and emerging safety issues
- Support development and implementation of the local pharmacovigilance system
- Perform local non-indexed literature screening and regulatory authority website screening for potential ADRs and safety information
- Maintain accurate local records and documentation
- Support the RA & PV Global Operations team
- Prepare and collect documentation for regulatory authority submissions
- Review and provide linguistic input on local Product Information and Mock-ups
- Ensure compliance with MAH and PrimeVigilance procedures
- Support audits and inspections
- Handle local QA tasks, including suspected falsified products, quality alerts, and other local-market quality requirements
Requirements:
- Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
- At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment
- Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
- Experience in case handling, literature screening, or local PV activities is preferred
- Prior experience in Regulatory Affairs is preferred but not mandatory
- Proficiency in English
- Additional language knowledge is advantageous
- Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint
Benefits:
- Flexible work arrangements / remote work
- Collaborative and supportive team environment
- Growth and professional development opportunities
- Global team and international work exposure
Similar Jobs
Senior Technical Compliance Analyst
Senior Technical Compliance Analyst strengthening DraftKings’ regulated gaming technology compliance programs. Leading audits, control validation, remediation, and compliance automation across technical teams.
Regulatory Labeling Manager
Regulatory Labeling Manager supporting Syneos Health’s life sciences clients with health-authority negotiations, safety-data interpretation, and eCTD labeling submissions.
Compliance Manager
Compliance Manager leading UK privacy oversight and DPO responsibilities at Affirm, a buy-now-pay-later company. Driving regulatory governance, monitoring, risk assessments, and second-line control challenge.
Regional Compliance Officer – Bilingual Eng/Span
Regional Compliance Officer helping MoneyGram strengthen AML and anti-fraud programs across US agents. Delivering compliance guidance, risk analysis, due diligence, and bilingual training.
Senior Associate Director, Compliance Management
Senior compliance leader driving GxP quality strategy, NC/CAPA processes, and clinical inspection readiness. Supporting Boehringer Ingelheim’s pharmaceutical product development and global quality initiatives.
Mortgage Regulatory Specialist
Mortgage compliance specialist supporting Lennar, a leading homebuilder, with regulatory guidance, testing, advertising reviews, and risk mitigation.
Network Services Operational Compliance Manager
Network compliance manager maintaining infrastructure stability, service controls, and supplier governance. Helping a London-based bank simplify technology and improve customer experiences.
Process and Compliance Analyst
Analista de Processos e Compliance monitorando indicadores, contratos, licitações e auditorias na Positivo S+, empresa brasileira de soluções gerenciadas de TI.
Compliance Nurse 2 – Long-term Care Program
Georgia health agency nurse surveyor inspecting long-term-care facilities. Documenting deficiencies, monitoring corrective action, and traveling extensively across the state.
Compliance Nurse 2 – Long-term Care Program
Georgia health agency nurse surveyor conducting on-site inspections of long-term care facilities. Reviewing care quality, documenting deficiencies, and monitoring corrective action across the Southeast region.
Compliance Officer
Compliance Officer overseeing HIPAA compliance, medical records, audits, and governance for a South African organisation. Maintaining documentation, accreditation readiness, and corrective action plans remotely during US hours.
Deputy Chief Compliance Officer
Deputy Chief Compliance Officer modernizing compliance across Tidal Financial Group’s ETF investment technology platform. Leading regulatory programs, risk remediation, broker-dealer infrastructure and technology-enabled controls.
Senior Manager, Quality Systems, Compliance
Senior Quality Systems and Compliance Manager supporting Iambic Therapeutics’ AI-driven medicines platform. Leading QMS implementation, audits, CAPA, and inspection readiness across clinical programs.
Compliance Specialist
Compliance Specialist conducting AML, sanctions, and financial crime investigations for Binance’s global cryptocurrency ecosystem. Supporting SAR reporting, UAE licensing, KYC/EDD reviews, and regulatory engagements.
Arquitecto SAP GRC
Arquitecto SAP GRC liderando implantaciones de Process Control y Risk Management para IRIUM España. Integrando GRC con SAP Audit Management en proyectos end-to-end.
Corporate Compliance and Ethics Expert – Director, Analyst
Corporate compliance analyst authoring research and advising executives for Gartner, a business and technology research firm. Shaping compliance strategies, risk frameworks, and regulatory responses.
Corporate Compliance and Ethics Expert, Director
Compliance and ethics analyst authoring research and advising Chief Compliance Officers for Gartner, a business research and advisory firm. Supporting regulatory risk, governance, and compliance program decisions.
Manager, Mortgage Compliance
Mortgage compliance manager overseeing licensing, regulatory compliance, training, and audits for Real’s integrated mortgage lending business. Supporting One Real Mortgage expansion and cross-functional legal initiatives.
License Compliance Sales Representative, Turkish Speaker
Turkish-speaking License Compliance Sales Representative helping Autodesk resolve software licensing violations. Negotiating settlements, audits, and commercial resolutions with customers.
Senior Regulatory Affairs Associate
Senior Regulatory Affairs Associate managing life-cycle regulatory submissions for Parexel’s clinical development solutions. Handling CMC authoring, health authority responses, variations, and post-approval updates across global markets.