16 oct
|
Ergomed
|
Buenos Aires
16 oct
Ergomed
Buenos Aires
Company Description
Medicine moves forward here. So will you.
At PrimeVigilance, patient safety is not one part of the job. It is why we exist.
We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.
That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.
If you want a role with real purpose, general reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.
Job Description
The RA & PV specialist will act as Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) and serves as the primary local RA&PV; representative to ensure compliance with national pharmacovigilance and regulatory requirements in Australia. This position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.
Main responsibilities
• Prompt and effective communication with MAH and local regulatory authorities as required
• Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
• Provision of local regulatory intelligence screening and expert advice for the responsible region(s)
• Collection and reporting of locally suspected ADRs or ICSRs (FUs,
📌 Specialist, Local Regulatory and PV network (Buenos Aires)
🏢 Ergomed
📍 Buenos Aires