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Pharmacovigilance (PV) Specialist
Job Description
Pharmacovigilance (PV)
- Collecting, assessing, performing and document the local quality control safety reports, transmitting them with a copy of the source documents to the HQ PV, and report to local HA following applicable procedure and regulations,
- Acting at the interface between the HQ PV and the reporters or the local Competent Authorities by relaying any question, answer or comment
- Applying locally the HQ PV quality documents in force (procedures, instructions, standard forms),
- Organizing the continuity of PV activities at local level, with the designation and training of an LRPPV back-up,
Quality Management System
- Ensure that a local quality management system is established, implemented and maintained, aligning with global standard operating procedures and instructions, local regulation and law, as well as accreditation that the affiliate upholds.
- Ensure local procedures are in place to ensure (not limited to) the handling and management of trainings, quality risk, documentation, vendor certification and monitoring, complaint, return, reject, recall, falsification, self-inspection, local supplementary labeling/packaging (if required) are performed effectively and in a timely manner in accordance with global SOP as well as local regulation and law.
Vendor management
- Be the quality contact person dealing with subcontractors including TPLs in Australia and New Zealand, of which the services and/or products have impact to GDP, patient safety and/or product quality
Routine GXP operation
- Carry out necessary steps to facilitate accurate and timely quality decision for GDP release of inbound goods arriving at TPL in Australia and New Zealand
Regulatory
- Prepare and submit regulatory applications for responsible projects to health authorities according to planned/ targeted timeline.
- Monitor routinely government legislation changes and implement necessary changes to the business in a timely manner.
Required Skills & Background
- Pharmacist required
- 1 -3 years’ experience in pharmaceutical company ( PV experience preferred)
- Proficient in MS Office, including Word, Excel and PowerPoint
- Proficient verbal and written English skills
- Strong communication, analytical and systems skills.
- Attention to detail and ability to multi-task
- Work systematically according to regulations
- High responsibility on duties
Reasons to join us
Much more than a Competitive salary, we offer continued personal development. When you join Guerbet, you:
- Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
- Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
- Are joining a company where we value diversity of talents coming from various horizons.
We # Innovate # Cooperate # Care #Achieve at Guerbet.