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Medical Reviewer

📍 Work location: Fully remote

🕒 Working hours: Availability for approximately 10 hours per month

💼 Contract type: Freelance contract with VAT registration

PLEASE NOTE: only applications sent to cv@clinopshub.com will be considered.

About us

ClinOpsHub S.r.l., founded in 2014 by Stefano Lagravinese, is a Contract Research Organization (CRO) self-certified with AIFA since 2019.

We are a recognized partner in the Clinical Research sector, providing services to pharmaceutical companies, investigational sites, laboratories, and other CROs, with a strong focus on quality, innovation, and professional development.

Role and objectives

The Medical Reviewer is responsible for the medical and clinical evaluation of safety information related to investigational medicinal products and adverse events collected during clinical trials.

The Medical Reviewer reports to the Responsible Person for Pharmacovigilance.

Main responsibilities

The Medical Reviewer is responsible for the following activities:

    • Reviewing and remaining up to date on the Study Protocol, related amendments, and relevant documentation; performing the clinical evaluation of each SAE occurring during the study, including the assessment of expectedness, causality, and seriousness, within the timelines defined in the Study Protocol; communicating the assessment to ClinOpsHub Pharmacovigilance staff and the Sponsor for the purpose of determining reporting obligations; preparing a summary of the evolving safety profile of the IMP to accompany the SUSAR line listing for communication to investigators, as specified in the clinical trial Safety Management Plan (SMP); preparing the Sponsor’s comments and assessment of Serious Adverse Events, where requested by the Sponsor; requesting any additional information or clarification from the investigational site required to complete the medical review.

    • Assessing the safety profile of the IMP on the basis of the Reference Safety Information (RSI) and clinical data from clinical trials; preparing the final safety evaluation for the DSUR; performing quality control of the DSUR.

    • Performing the medical evaluation of received SAEs, SUSARs, and any adverse reactions.

    • Reviewing the annual safety report during the study. The Medical Reviewer may play an essential role in identifying SAEs and resolving discrepancies.

Required qualifications and skills

    • Degree in Medicine and Surgery;

    • Previous experience in pharmacovigilance, particularly in a pre-marketing setting, or in clinical research;

    • Strong knowledge of regulatory requirements related to pharmacovigilance and safety data reporting;

    • Knowledge of ICH E6 (R3) Good Clinical Practice, ICH E2A, ICH E2F and Regulation (EU) No. 536/2014.

    • Excellent attention to detail and strong organizational skills;

    • Ability to work both independently and collaboratively within a team;

    • Excellent written and verbal communication skills;

    • Good command of data management and analysis.

Equal Opportunities

This job posting is open to candidates of all genders, ages, and nationalities (Italian Legislative Decree 198/2006 and Directive 2000/78/EC).

ClinOpsHub actively promotes diversity: equal qualifications considered, priority may be given to candidates from underrepresented groups within the team.

Privacy

Personal data will be processed in accordance with Regulation (EU) 2016/679 (GDPR) and applicable data protection laws.