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    Pharmacovigilance Specialist

    Thornshaw Recruitment
    3+ years
    Not Disclosed
    Dublin
    15 June 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Pharmacovigilance Specialist

     

    On behalf of our client, a Global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Specialist based in Dublin.

     

    Your role will be to support the Global Pharmacovigilance Team with but not limited to the Safety Data Exchange Agreements management, Quality Management System related activities, service provider management (case processing / Art 57 – XEVMPD) and Pharmacovigilance System Master File maintenance.

     

    Responsibilities

     

     

     

    • Support the Global PV team with PV agreements management (Safety Data Exchange Agreements), updates and implementation. Support the Global PV team in overseeing the pharmacovigilance activities performed by company affiliates, and the national pharmacovigilance contact persons where applicable. Coordination of Medical Information activities with the support of the Medical Affairs team and standardization of practices across the organization. Support the Global PV team with quality management related activities including but not limited to training, procedural documents updates, deviations management, CAPAs implementation arising from pharmacovigilance-related audits and inspections. Support the Global PV team with the maintenance of the validation status of the global PV database, management of the Global PV database service provider. Support the Global PV team with the maintenance of the Pharmacovigilance System Master File, including liaison with the stakeholders to ensure the data are collected in a timely manner and in high quality.

     

     

     

     

    Education & Experience

     

     

     

    • Degree in Life Sciences. Minimum 3 years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization. Understands and maintains strong working knowledge of PV global regulations and guidelines with PV operational knowledge. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Ability to establish working relationships with people globally and locally, in various functions with a wide variety of disciplines and backgrounds.

     

     

    For full details contact Tina at +353 1 2784701 or email your CV to tdunne@thornshaw.com

     

    Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

     

    Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

    Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

    Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

    Our Industries

    We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

    Our Specialities

    Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

    Our Mission

     

    For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

     

    Company info

    Website

    http://www.thornshaw.com/

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