POST-MARKETING SAFETY EXPERT CONSUMER

COMPANY INFO:
MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.

Our client embraces research and science - bringing innovative ideas, products and services to advance the health and well-being of people and is seeking to add a Post-Marketing Safety Expert (PSE), Consumer to their team in Fort Washington PA.

RESPONSIBILITIES:
•    Under the oversight & delegation from the QPPV & deputy QPPV, translates the strategy & oversees the execution of the pharmacovigilance activities associated with the risk mgt. Plans, ad-hoc reg. Response, and safety.
•    Reviews by pharmacovigilance matrix teams. The PSE owns the post-marketing safety. Plans & will review post authorization safety studies for medical importance to the safety profile of the product. Oversees development of safety labeling.
•    On behalf of QPPV office, review & sign off aggregate reports prepared by the pharmacovigilance sciences group. Make recommendations on actions required to maintain a positive risk benefit for products, such as labeling changes.
•    Participate in the preparation & sign-off of other documents relating to product safety. Work w/ teams from other functions & licensing partners on assessment of safety issues.
•    Assess safety & risk benefit of assigned auth. Products.
•    Review & sign-off aggregate RPTS. From PV science group for reg. Authority submissions.
•    Advise on the appropriate Strategy for reg. Authority submissions & assessments.
•    Provide med. Input on franchise area to other functions in BRM, such as integrated safety operations personnel.
•    Advice on the suitability of licensing & acquisition candidates, and advise on health implications of quality issues & recommendations for action.
•    Effective decision-making with problem-solving capabilities is required.
•    Medical evaluation of adverse event reports, including but not limited to all serious and expedited reports and all pregnancy reports. Preparation of IND letters to investigators (SUA summaries).
•    Provide medical guidance and opinions to drug safety associates, other physicians and scientific staff in the evaluation and follow-up of individual case safety reports. Provide medical input for ad-hoc queries as requested.
•    Participate in signal detection efforts, e.g. strategy meetings and periodic reports and structured surveillance programs and other medical/scientific meetings. Review aggregate reports such US Periodic Reviews and non-serious line listings of events on a weekly basis to assess correct seriousness classification.
•    The primary decision making responsibility centers on the assessing the medical significance of the individual case safety report. The PVP evaluates each adverse event report for seriousness, labelledness, corrects coding of the adverse event and ensures that all medically relevant information from source documents are included in the applicable reports.
•    When necessary, the PVP requests the Safety associate to inquire for additional relevant information, per SOP and will discuss cases of particular interest with the PV Physician Team Lead, Post-Marketing Safety Expert, and/or safety surveillance physician.
•    Prepares an SUA summary (letter to the investigator) for serious, unlisted, associated adverse events occurring in specified IND trials. In performing these activities, the PVP is responsible for following international pharmacovigilance regulations, company and department SOPS and department and function working practices.