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.