This position is a one year contract.
- Assess the relationship between drugs and adverse events. Analyze events collectively, tracking etiologic and numeric trends in both serious and non-serious cases, to evaluate impact of product on exposed population.
- Develops responses for submission to International Regulators, which support development, approval, sales & marketing of company products and which accurately reflect both the potential risks and benefits to the target population.
- Formulates and represents company opinion to co-marketing partners and international regulatory agencies
- Represents company Product Safety on Local Project Teams.
- Member of the Global Safety Board and International Project Teams for assigned products, serving as General Safety Officer for assigned compounds in development and marketed.
- Responsible for the review and analysis of cumulative adverse event reports for marketed products and products in development, for the purposes of preparing Aggregate Reports for submission to global Regulatory Authorities.
- Participates in international communications regarding safety issues and adverse events, international labeling criteria, core safety data sheet.
- Assists in the review of promotional and marketing materials, medical communications policy and documents.
- Provides coaching and subject matter expertise to internal and external team members.
- Provides medical expertise to questions posed by specialists in the review and evaluation of safety information for investigational and marketed products, including and provides guidance on case reportability per local
- Timely preparation of aggregate reports and responses to Regulators and questions form external and internal customers.
- Provide the views of safety to different committees (i.e., IPTs; certain cross-departmental and cross-organizational teams)
- Responsible for establishing the company position on marketed product safety
- Evaluate incoming data continuously to determine the need for proactive positioning to protect the safety of patients
- Assure that company is meeting its regulatory requirements for clinical trial safety reporting and post market safety surveillance
Responsibilities Percent of Time
- Represents independent safety opinion on international project teams and clinical trial design and results review, final study reports 35%
- Coordination with other Medical Service Personnel, Clinical Research and other areas of the company. 15%
- Preparing narrative discussions of collective events, preparation of aggregate reports 35%
- Participation in the Global Safety Board and Coordination with Local and Regional Safety Officers 10%
- Administration, Education and miscellaneous 5%
- MD degree, US Board Certified/eligible
- 4 + years’ experience in pharmaceutical development or related industry
- 1-2+ years’ experience in a role as a medical reviewer of adverse event reports
- 2+ years in a role requiring knowledge of Disease pathology and physiology, pharmacology and therapeutics, International and US Regulatory Reporting Requirements for Product Safety, pharmaceutical development process
- 2 + years in a role of preparing aggregate reports and submission ready responses to Regulators on pharmacovigilance issues.
- Ability to work effectively in cross-departmental, cross-organizational teams.
- Strong organizational, written and verbal communication skills
- Computer skills.