Our client is a clinical stage biotechnology company. They have asked us to assist them in their search for a Director, Pharmacovigilance.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Performs medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs).
- Composes, edits, and medically reviews Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
- Serves as an internal consultant to pharmacovigilance case processing teams on projects being supported.
- Provides aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile.
- Provides coding review of AEs, Past medical history, Concomitant medications, or other medical data listings to verify and medically validate clinical data.
- Provides medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports.
- Provides medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk.
- Completes all departmental project activities accurately in accordance with company SOPs, Project Specific Procedures, regulatory requirements, and client processes.
- Assists in the preparation and conduct of code-break activities.
- Guides staff, consultants, and partners with regards to the regulatory reporting of adverse events.
- Assists with generation of project specific procedures (medical review workflow activities).
- Supports QPPV and management as required.
- Liaises with investigational site, as necessary regarding safety issues.
- Liaises with company Medical Monitor, project manager, and other departments, as appropriate.
- Attends project team and external meetings (including Investigator meetings) and teleconferences as required.
- Participates in Business Development activities as requested.
- Provides medical oversight for label development, review, and change.
- Provides medical support and attendance at Data Safety Monitoring Board Meetings.
- Attends and contributes medical safety evaluation on Safety Monitoring Committees.
- Provides medical safety contributions to the Integrated Safety Summary or Common Technical Document.
- Reviews and signs off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope.
- Provides medical escalation support for medical information projects.
- Provides medical escalation support for EU Qualified Persons for Pharmacovigilance projects.
- Maintains awareness of medical-safety-regulatory industry developments.
- A Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.
- Must have five to seven years of prior relevant experience.
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research is required.
- Must have knowledge of regulations and guidelines pertaining to safety and good clinical practice.
- Knowledge of clinical trials and pharmaceutical research processes is required.
- Requires the ability to establish and meet priorities, deadlines, and objectives.
- Must be skilled in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.
- The ability to establish and maintain effective working relationships with coworkers, managers and clients is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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