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Pharmacovigilance Operations Associate (Physician)

Buffalo, New York

Post Date: 11/02/2017 Job ID: 1603 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety

As a Pharmacovigilance Operations Associate (Physician), you will support the Pharmacovigilance team in reviewing, querying, documenting and reporting on all serious adverse events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR) cases related to clinical studies.

Job Responsibilities:
  • Provide timely and sound medical review of individual case safety reports (ICSR) from clinical trials.
  • Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available.
  • May participate in the case narrative generation, review and refinement process depending upon level of experience.
  • Conducts several rounds of query and response (back to site) to gain complete and accurate case information.
  • Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications.
  • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
  • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
  • High Comfort Level in working in Multidisciplinary teams; providing input in team meetings and relaying information to PV management.
  • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
  • Contribute to preparation and review of periodic reports (DSUR, CSR)
  • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
  • Participate in departmental development activities including Training Staff, SOP and Work Instructions development.
  • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
  • Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
  • Participate in Risk Management Strategy
  • Other activities, as needed or as requested by manager.


Qualifications/ Requirements:
  • Doctor of Medicine or Doctor of Osteopathic Medicine required; equivalent foreign medical graduates may be considered.
  • A minimum of 3 years Drug Safety/Pharmacovigilance experience in a pre-approval setting.
  • Oncology experience required.
  • Experience with Oracle’ s Argus Safety Suite or comparable database required.
  • Strong familiarity of GCP, ICH and Global regulations.
  • Experienced in the evaluation and interpretation of data
  • Ability to multi-task
  • Solid written and oral communication skills.
  • Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner.
  • Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.
  • Close attention to detail.
  • Ability to collaborate well with others.

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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