Agenus

Executive Director of Drug Safety

US-MA-Lexington
Job ID
2017-1274
Category
Development

Overview

Executive Director of Drug Safety

The Executive Director of Drug Safety will provide Agenus ( www.agenusbio.com(with the vision, leadership, strategy, analysis, tactical implementation plans and opportunity to develop an exceptional Pharmacovigilance program. This position will   ensure the safety of drug development activities including leading drug safety surveillance and ensure that all is in compliance with company standard operating procedures as well aas all state and federal regulations .

Key Responsibilities

  • Responsible for providing leadership and overseeing  the drug safety process for the company;
  • Directs of the quality of all drug safety programs and drug safety deliverables;
  • Development of strategic priorities, processes and operating procedures to ensure compliance with appropriate regulations and quality standards;
  • Heads the process for drug safety surveillance and ensures safety of drug development activities in compliance with state and federal regulations and company standard operating procedures;
  • Oversees the evaluation, analysis and reporting of adverse events in compliance with global safety regulations, and all company standard operating procedures and policies;
  • Collaborates with other relevant departments;
  • Directs a safety surveillance committee;
  • Develops a team capable of successfully implementing company and quality objectives;
  • Communicate effectively to cross organizaionally regarding department and staff goals as well as priorities and policy;
  • Ensure organizational financial and strategic goals are attained.

Qualifications And Experience

  • M.D. with 10 -15 years of relevant work experience;
  • Demonstrated ability to apply effective critical thinking and problem-solving skills;
  • Ability to manage multiple tasks with deadlines in a fast-paced working environment;
  • Experience in regulatory requirements and guidelines pertaining to Pharmacovigilance;
  • Attention to detail and accuracy;
  • Proven cross-functional teamwork skills;
  • Exceptional verbal and written communication skills;
  • High level commitment to business ethics

Responsibilities

Responsible for providing leadership and overseeing  the drug safety process for the company;

  • Directs of the quality of all drug safety programs and drug safety deliverables;
  • Development of strategic priorities, processes and operating procedures to ensure compliance with appropriate regulations and quality standards;
  • Heads the process for drug safety surveillance and ensures safety of drug development activities in compliance with state and federal regulations and company standard operating procedures;
  • Oversees the evaluation, analysis and reporting of adverse events in compliance with global safety regulations, and all company standard operating procedures and policies;
  • Collaborates with other relevant departments;
  • Directs a safety surveillance committee;
  • Develops a team capable of successfully implementing company and quality objectives;
  • Communicate effectively to cross organizaionally regarding department and staff goals as well as priorities and policy;
  • Ensure organizational financial and strategic goals are attained.

Qualifications

         M.D. with 10 -15 years of relevant work experience;

  • Demonstrated ability to apply effective critical thinking and problem-solving skills;
  • Ability to manage multiple tasks with deadlines in a fast-paced working environment;
  • Experience in regulatory requirements and guidelines pertaining to Pharmacovigilance;
  • Attention to detail and accuracy;
  • Proven cross-functional teamwork skills;
  • Exceptional verbal and written communication skills;
  • High level commitment to business ethics

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