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US: Medical Director

Date: 04-Feb-2014
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Medical Director

Prepare/review aggregate safety reports for submission to domestic and international regulatory authorities

Contribute to and support development of evolving risk management plans Prepare and maintain summary analyses of safety data on key events from all available sources including the literature

Accurately identify safety issues that require further evaluation and Effectively collaborate with interdisciplinary team in the evaluation and management of safety issues during clinical development

Medical physician with a minimum of 2 years experience in the pharmaceutical, biotech, or contract research organization in Pharmacovigilance & Drug Safety or Pharmacoepidemiology.

Minimum of 1 year clinical experience in academic or private practice including hospital based setting.

Advanced knowledge in pre and post-marketing, US and international, safety regulations

Ability to formulate and lead and investigative plan as well as develop sound risk assessment

Advanced ability to analyze and interpret clinical data Strong analytical skills

Ability to influence others (cross-functionally and within the function) to create a positive working environment

Ability to work under pressure and dependably deliver high quality results in a timely manner

Experience in developing, executing RiskMaps/ Risk Management Plans Strong commitment to business ethics

Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners

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Thank you,
BioTech FYI Center