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Brand Safety Leader/Sr. Pharmacovigilance Leader, Switzerland - Oferta z Jobs.pl

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Brand Safety Leader/Sr. Pharmacovigilance Leader, Switzerland

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  • For our Life Science client in Basel, we are seeking either a Brand Safety Leader (BSL) OR a Sr. Pharmacovigilance Leader (PVL)

    Start Date: ASAP

    End Date: 30th April' 2017 + extensions

    Location: Basel

    Language: English

    Your role as a Brand Safety Leader:

    • Safety issue management from end of Phase I (POC) through Life Cycle Management
    • Accountable for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, postmarketing data, and other sources.
    • Accountable for developing and updating, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant. Accountable to ensure adequate risk management plans are in place.
    • Leads Safety Management Team.
    • Serves as safety representative as core member of Global Program Teams. Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.
    • Accountable for integrated safety input into all safety relevant parts of regulatory and company documents (ie IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, etc) required during active development, submission phase and during marketing phase.
    • Review of medical safety input into study protocols (including MRC and OPCE), MAP, RAP, and ICF.

    Your role as a Sr. Pharmacovigilance Leader:

    • Acts as the primary contact point with PVE in HYD, CSS and co-ordinates product-specific activities.
    • Performs medical review of individual SAEs from clinical trials with the support of the PVE as applicable and is responsible for preparation/submission investigator notifications
    • Performs medical evaluation of quality defects.
    • Acts as back-up for medical review and assessment and related activities for single cases (post-marketing and/or clinical trials), including requesting additional medically relevant information.
    • Identifies safety signals based on the review of solicited or unsolicited single case reports, aggregate data and signal detection tools (ie EMPIRICA) and performs signal evaluation and monitoring.
    • Prepares clinical expert statements related to signal evaluation (eg literature, clinical; non-clinical, epidemiology).
    • Responsible for review of study protocols (including MRC or OPRC if applicable).
    • Responsible for medical input to aggregate clinical safety regulatory reports (eg, PSUR, DSUR).

    Your Experience:

    • MD
    • At least 5-7 years of experience in Global Drug Safety (preferably Big Pharma)
    • Broad experience in safety regulations and requirements; desirably knowledge of trials in oncology
    • Good writing skills (aggregated safety reports etc.)
    • Leadership (leading international cross functional teams); preferable candidates who worked as well already in other areas outside of Safety before (eg, Clinical, Medical affairs etc.)

    We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.

    We hope that the role will be of interest to you and understand that further information may be required prior to an application to the end client, please feel free to email or call me at anytime with any questions you may have.

    Looking forward to hear from you soon,

    Kind regards,

    Neha Sharma

    Pharmaceutical & Life Sciences Business Developer

    Michael Bailey Associates

    Michael Bailey International is acting as an Employment Business in relation to this vacancy.


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