BriefCase
BriefCase

Safety Physician Pharmacovigilance Job in Clinipace

Safety Physician Pharmacovigilance

Clinipace 4+ weeks ago
Apply Now
Job Summary
  • At least 3years of experience within the clinical arena post-training and preferably at least 3 years in the pharmaceutical, biotech, medical device and/or CROs. CRO experience highly desirable.
  • Experience working in a drug safety / pharmacovigilance or drug development environment performing medical review of clinical and post-marketing data.
  • Prior experience as Safety Physician Pharmacovigilance (or equivalent roles) is highly desirable.
  • Experience or knowledge of safety signal management approaches;
  • Experience in project management and team leadership;
  • Experience in development and delivery of the trainings and presentations.
  • Skills/Competencies
    • Clinical thinking: ability to perform critical review and answer questions of medical nature from sites, project team (incl. Sponsor/Client) in accordance with ICH GCP guidelines, project specific documents to ensure patient safety, data integrity and successful completion of project;
    • Deep understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of medical device, vaccines and drug development process;
    • Deep understanding of safety databases and pharmacovigilance processes;
    • Effective communication: comfortable communicating both inside and outside to company;
    • Mature Management: management with a calm, positive winning attitude and excellent decision making skills;
    • Strong knowledge of the drug/device/vaccine development process;
    • Regulatory guidelines expertise: knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, MHRA, Pharmaceuticals and Medical Devices Agency (PMDA), GVP Modules; respective EU Clinical Trial Directive etc.);
    • Training expertise: able to efficiently train others;
    • People management: able to clearly and efficiently communicate with site and team members;
    • Clinical Management: able to manage clinical projects successfully;
    • Time management: good sense of urgency, prioritization skills;
    • Team player: effective participant as a team member and team leader;
    • Creative and positive leadership: programming team success through establishing and clear articulation of goals;
    • Creative problem solving skills;
    • Effective oral and written communication and presentation skills (at least in English) is compulsory;
    • Coach: a passion to assist others in becoming all they can be; Achievements: ability to define and meet requirements;
    • Integrity: Understanding and acting on principles of honesty, trust and fairness.
    •
    Experience Required :

    Minimum 3 Years

    Vacancy :

    2 - 4 Hires

    Similar Jobs for you

    See more recommended jobs