PV Italy Support Specialist

Planet Pharma; Roma; In loco; EUR 38.000 - 52.000; Tempo pieno

Descrizione del lavoro

Planet Pharma Italy is seeking a Pharmacovigilance Support Specialist to join our team. You will evaluate medical reports related to drugs and devices, assess safety signals, and contribute to EU regulatory compliance, reporting findings to cross‑functional teams.

The role requires strong pharmacovigilance knowledge, MedDRA familiarity, and excellent communication. Italian fluency is preferred, with English as optional.

Competenze

• Bachelor's degree in Pharmacy, Medicine, Life Sciences or related field.
• 2+ years in pharmacovigilance or drug safety preferred.
• Experience with EU regulatory requirements and safety reporting is a plus.

Mansioni

• Evaluate medical reports related to drugs and medical devices for safety and regulatory compliance.
• Perform signal detection, assess severity and causality, and contribute to safety database management.

Conoscenze

Pharmacovigilance

Signal detection

PSUR

RMP

Medical assessment

MedDRA coding

Regulatory compliance

Data analysis

Communication

Formazione

Bachelor's degree

Descrizione del lavoro

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.I>
• 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.

Bring your expertise and enthusiasm to this exciting pharmacovigilance opportunity-