Associate / Medical Director, Global Drug Safety, Neuroscience

Job Description

The Global Safety Physicianwill be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. The Global Safety Physician will represent Biogen Safety in internal and external meetings. The Global Safety Physician can be appointed as the Global Safety Officer for a specific product. Responsible for keeping upper management informed of safety issues.

The Global Safety Physician will demonstrate the flexibility and capability to function at a high level across multiple disease areasand will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through their life cycle. This person will also interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.

1. Manage safety surveillance for assigned products

a. Collaborate with PV scientists and other stakeholders

b. Conduct analyses of safety trial data.

c. Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality.

2. Provide safety strategic leadership for clinical development programs

a. Integrate the safety scientific component to build a strategic framework for clinical development plans.

3. Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.

4. Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.

This position is ideally based in Cambridge, MA (USA).

Who You Are

You are a proven leader and strive on developing, executing and advancing successful programs in development. You have experience working / leading high performing teams; providing the necessary guidance and mentoring for all to reach their goals.

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Qualifications

  • MD or MD/PhDrequired; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred
  • Minimum 5+years experience in the pharmaceutical industry or clinical care setting; ideally 3+ years of overall experience specific to pharmacovigilance.
  • Prior experience in clinical trials; academic and/or industry.
  • Knowledge of pre- and post- marketing US and EU regulations




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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