Medical Director, Pharmacovigilance and Risk Management (244-419)
ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.
- Perform clinical assessment of SAE cases reported from clinical trials; perform Sponsor causality assessment; determine regulatory reportability
- Work closely with Drug Safety and PVG staff in the proper gathering, evaluation, medical assessment and follow-up of individual case safety reports
- Identify and analyze possible trends and concerns with company products including the identification and evaluation of safety signals through the assessment of single case safety reports, aggregate trend analyses and review of relevant literature for safety information pertinent to product safety
- Perform review of adverse event, medical history and concomitant medication coding into WHO-Drug and MedDRA codes
- 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
- Contribute to and support safety sections clinical investigator brochures, risk profiles, protocols, and regulatory reports (e.g. Annual IND report; 6-monthly line-listings; EU Annual Safety Report)
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.
- 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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ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.