Associate Medical Director, Patient Safety - MD
Laboratory Corporation of America Holdings (Covance)
WARSAWA, Poland
3 d. temu

Reporting to the Senior Medical Director, the incumbent will be largely responsible for the medical review of serious adverse events derived from clinical trials, in support of drug safety activities for clients.

  • Responsible for medical review of serious adverse events and adverse events of special interest from Clinical Trials in support of safety activities for clients.
  • Reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed to identify drug safety issues in collaboration with the project physician
  • When applicable, responsible for preparation and medical review of Aggregate Reports (Periodic Safety Update Reports PSURs, Periodic Adverse Drug Experience Reports PADERs) required by global regulatory agencies for review of safety information for assigned products, when authorized to perform this function on behalf of a client.

    When applicable, responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products, when authorized to perform this function on behalf of a client.

    Participates in training opportunities to advance knowledge of pharmacovigilance and serves as a consultant on pharmacovigilance issues to the project physician

    Provides medical / safety expertise to project teams, including communicating information regarding drug safety regulations and any changes that have occurred

    Assists in the preparation of pharmacovigilance materials for investigator meetings

    Assumes responsibility for medical and safety monitoring on assigned projects

    Provides mentoring of and indirect supervision of Senior Drug Safety Associates, and Drug Safety Associates

    Responsible for communicating status of projects and other activities to the Senior Medical Director (Lead) and others as appropriate.

    Experience : Required for Associate Director level : (115)

    At least 2 years of experience working either for a pharmaceutical company, health authority or a contract research organization in related fields such as QA, Regulatory Affairs, medical writing, PCS, TM or clinical medical monitoring

    Education / Qualifications / Certifications and Licenses :

    Required :

    MD or DO with at least one year of postgraduate training or equivalent.

    Preferred :

    MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management

    Competencies :

    Required : Strong communication (oral and written English) skills

    Good interpersonal skills

    Well organized

    Ability to work independently and in teams

    Good prioritization skills

    Ability to adjust to changes in tasks as required

    Ability to provide leadership and guidance to indirect reports Senior Drug Safety Associates and Drug Safety Associates

    Ability to represent the company at client, industry and medical meetings

    Travel Requirements : Yes ; Up to 20% of time

    Language Skills Required :

    Speaking : Yes No English at ILR level 3+ or higher

    Writing / Reading : Yes No English at ILR level 4 or higher

    Labcorp is proud to be an Equal Opportunity Employer :

    As an EOE / AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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    2022-04-28 00 : 00 : 00

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