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
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
