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Medical Reviewer m/f

Objavljeno
2024-05-31
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Location

Zagreb

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Category

Healthcare

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Type of work

Full-time

Job description

Lugera Talent Solutions (ex. Adecco) is leader in providing HR services.

Our client is a global healthcare company that believes in a better and healthier every day for every woman. They are a passionate, global community of thousands dedicated to redefining the future of women’s health. Their mission is to deliver impactful medicines and solutions for a healthier every day.
We are seeking a real, passionate team player, a curious innovator, and a forward thinker empowered by the idea of shaping their career. If you're ready to bring your fire to embrace change and seize opportunities, we invite you to join the team as:

Medical Reviewer m/f
Location: Zagreb

ABOUT THE ROLE:

Medical Reviewer performs in-line medical review and medical assessment and ensures scientific consistency of individual case safety reports (ICSRs) of company medicinal products and reportability assessment for medical device and combination product cases in accordance with global PV regulations. The Medical Reviewer contributes to the development, implementation, and optimization of processes used to ensure operational and scientific consistency of the in-line medical safety assessment of company products (medicinal, combination and medical devices) in accordance with global PV regulations.

MAIN RESPONSIBILITIES:

• Contributes to the development of and maintenance of comprehensive and compliant medical review and medical assessment processes to drive efficiency into the medical safety review business process, introducing automation where possible
• Ensures implementation of new or updated regulations and/or ICH Guidelines regarding in-line medical assessment to ensure regulatory compliance for individual case safety reports
• Provides in-line medical assessment of individual case safety reports in the context of the available safety data and the known safety profile to assess expectedness and formulate a company statement and a causality assessment as per timelines determined by OARS workflow
• Provides in-line medical assessment of harm or potential harm associated with device or device-constituent to support individual case safety report (ICSR) reportability determination as per timelines determined by OARS workflow
• Serves as a subject matter expert for in-line medical assessment of individual case safety reports during audits and inspections
• Provides device legislation expertise in relation to medical review and medical assessment and reporting responsibilities
• Consults with TA lead Clinical Development Safety and/or Clinical Research as needed for cases requiring additional safety or clinical subject matter expertise
• Escalates potential safety issues to the attention of the Head Medical Safety Excellence and Safety TA Leads
• Contributes to the preparation and responses to Regulatory Agency Inspections as well as internal and external audits

WHAT YOU’LL NEED:
• Doctor of Medicine (MD) or equivalent degree
• A minimum 5 years of work experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities
• Strong knowledge of clinical research process, pharmacovigilance processes and end to end process of individual case safety reporting for both clinical research and Post Marketing environments
• Strong knowledge of interpretation of adverse experience information and regulatory legislation for medicinal products.
• Experience in global Medical Device regulations and device safety monitoring
• Problem solving, conflict resolution and critical thinking skills
• Excellent presentation, writing and communication skills
• Ability to consistently deliver on deadlines, with high standards for quality and sense of urgency
• Collaborative and team orientated
• Fluency in English

Please be advised that the contract duration is for a definite period of 12 months.

If you are enthusiastic, dynamic, eager to develop, wanting to have an influence on what is happening and open for challenges, please send us your CV in English via application link and join this amazing team.

Note: Please mind that only the candidates selected for further consideration will be contacted and notified about the selection process

Dozvola za obavljanje djelatnosti u svezi sa zapošljavanjem ministarstva nadležnog za rad br. 178/20.

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