27 set - Breda di Piave
Planet Pharma
Job Title: Pharmacovigilance Support Specialist – PV Italy
Overview:
Join a dynamic team supporting critical pharmacovigilance activities for a prominent Italian client. As a PV Italy Support Specialist, you will play a key role in evaluating medical reports related to drugs and medical devices, ensuring patient safety and regulatory compliance across the EU. This role offers an exciting opportunity to contribute to healthcare safety initiatives while working within a collaborative environment that values expertise and precision. If you are passionate about pharmacovigilance and eager to make a meaningful impact, this position is your gateway to a rewarding career.
Required Skills:
- Strong understanding of pharmacovigilance processes, including signal detection, PSUR, RMP, and medical assessment of incidents.
- Experience in evaluating reports linked to drugs and medical devices, with the ability to assess severity, causality, and impact.
- Knowledge of MedDRA coding and familiarity with RCP guidelines.
- Excellent analytical and communication skills to compile and report detailed safety evaluations.
- Ability to review signal detection reports and contribute to safety database management.
Nice to Have Skills:
- Prior experience supporting EU or global pharmacovigilance teams.
- Experience with notifications, follow-up requests, and safety reporting procedures.
- Fluency in Italian and English languages for seamless communication with local and international teams.
Preferred Education and Experience:
- Bachelor’s degree in Pharmacy, Medicine, Life Sciences, or a related field.
- Previous experience in pharmacovigilance, medical assessment, or drug safety roles preferred.
- Ideally, 2+ years working in a pharmaceutical or healthcare setting with regulatory compliance focus.
Other Requirements:
- Some collaboration with client data management and QA teams, with potential for on-demand support.
- This position may require occasional communication with regulatory bodies and internal stakeholders.
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