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Pharmacovigilance Operations Associate (Physician)

Buffalo, New York

Post Date: 08/19/2017 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.

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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