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Director/Senior Director. Pharmacovigilance & Drug Safety. United Stat - Oferta z Jobs.pl

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Director/Senior Director. Pharmacovigilance & Drug Safety. United Stat

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  • Director/Senior Director. Pharmacovigilance & Drug Safety

    United States. East Coast. Office Based

    Exciting Growth Clinical Development Company

    The Role:

    My client, is an exciting and fast growing organisation with clinical research developments in targeted therapeutic areas. Currently involved in multiple ongoing clinical studies with progressing developments within its specialist fields of research.

    As a result of continued business development and upscale across departments, they now also seek an experienced industry MD Drug Safety Physician to join the expanding Pharmacovigilance team at their offices on the East Coast, United States.

    This senior Pharmacovigilance and Safety opportunity requires a certified MD Physician with at least 8+ years progressive direct industry experience within safety and vigilance.

    Ideally you will have at least 2+ years direct experience working within a smaller company start up / biotech organisation - with experience working in a hands on and operational roll. You will be able to demonstrate the abilities and skills required for working in a smaller fast paced growth organisation. Demonstrating you can adapt, act to fast change, and roll up the sleeves - getting involved in all aspects of the operational needs at all levels, whilst getting on with multiple tasks with tight timelines - without the need for close supervision or ongoing direction.

    You will be a certified MD Physician who is either US based or eligible to work in the United States. You will have extensive knowledge of FDA / European and global PV requirements.

    Your experience within industry to date will show a proven career development path to senior manager / director level within Pharmacovigilance and drug safety.

    Oncology experience / speciality within industry and or clinical would be advantageous

    Experience/Skills Required:

    MD. With local/national and global experience in Pharmacovigilance & Safety: 8+ Years
    4+ Years experience in a senior PV position
    2+ Years Experience in a Start Up / Biotech organisation
    Proven operational and management experience - Can do attitude / Hands on approach
    Extensive knowledge of US and Global Pharmacovigilance regulations and legislations - FDA, EU and ICH guidelines
    Exceptional interpersonal / presentation / team development and communication skills
    Expertise with SAE analysis / SAE coding / Safety reports / ICSRs, SUSARs, DSUR, ASR
    Solid industry experience within GvP Pharmacovigilnace and GCP (Good Clinical Practice) Research & Clinical development
    Experience with PV inspections, PV auditing and PV documentation systems

    If you are an experienced and senior level industry MD Safety Physician working within Pharmacovigilance and Drug Safety in the Unites States / North America / Canada, or you are eligible to work in the United States without Visa requirements - Contact today for more information.

    Excellent and Competitive base salary offering and associated benefits
    Bonus to 20%
    Relocation assistance - Available. Cash Amount / Sign On Bonus
    Office Based - United States. East Coast

    Email Your CV to:

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