Sr. Drug Safety Specialist (Contract)

US-NJ-Jersey City
ID
2017-1054
# of Openings
1
Category
Drug Safety

Overview

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

 

Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

 

The Senior Drug Safety Specialist is responsible for completing all aspects of individual case safety report (ICSR) processing and reporting for assigned investigational and marketed products, while also assisting management in implementing departmental strategy. The Senior Drug Safety Specialist supports and participates in drug safety assessment and management. The Senior Drug Safety Specialist serves as a liaison to external service providers (i.e. clinical research organizations), investigational sites, and company personnel for safety-related issues, working in close collaboration with colleagues from Clinical Research, Data Science, Regulatory and Quality Assurance.

Responsibilities

  • Performs data triage of source documentation and confirms valid individual case safety reports (ICSRs). Tracks the status of AE reports, performs electronic submissions and monitors metrics for compliance with ICSR reporting requirements to the global regulatory authorities.
  • Manages CRO case processing activities in the safety database with respect to compliance with safety agreements. Interacts with the daily operations of a contract research organization (CRO). Active participation in quality assurance and archival of safety data.
  • Contributes, authors, reviews, and maintains safety sections of clinical documents including investigator’s brochure, clinical study protocols, clinical study reports, development core safety information, and development risk management plans
  • Prepares periodic safety reports for the FDA including quality review of narrative summaries and quality assurance of the data prepared by the CRO. Author responses to regulatory agency inquiries and safety sections as required.
  • Manages business partner exchange of AE reports in accordance with safety data exchange agreements and performs reconciliation
  • Evaluates and identifies areas needing improvement or clarification and drafts procedural changes and adaptations as needed.
  • Prepares SOP’s and work practice documents.

Qualifications

  • Bachelor’s degree required in a health care discipline. BSN, PharmD, PA preferred.
  • 6 to 8 years significant clinical safety or pharmacovigilance experience
  • Ability to analyze laboratory data and review source documentation of ICSRs. Strong ability to construct narrative summaries of AE data from source documentation. Knowledge of regulatory reporting requirements and formats for the FDA and international regulatory authorities. Computer skills including knowledge of databases and querying databases for preparation of data analysis. Experience with adverse event coding dictionaries (MedDRA).
  • Strong knowledge of safety monitoring and pharmacovigilance. Experience in medical writing, strong interpersonal and communications skills, as well as organizational and problem-solving skills. Ability to collaborate and interact with a wide range of health professionals and company personnel. Knowledge of preparation of periodic safety reports required.
  • Strong knowledge of FDA regulatory reporting requirements and GMP as well as GCP guidelines. Strong interpersonal, communication and organizational skills.
  • Ability to write SOPs and other working practices and documents within the context of clinical and post-marketing drug safety reporting.
  • Ability to write periodic safety reports. Must have excellent written and oral communication skills.
  • Must have resourcefulness and personal organization skills.
  • Applies critical thinking skills to solve problems by generating, evaluating, and implementing solutions.

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