Associate Director, Drug Safety
Infinity Pharmaceuticals, Inc. - Cambridge, MA

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Position Overview:

The Associate Director of Drug Safety will be responsible for managing clinical trial SAE processing and drug safety activities within the Infinity Pharmacovigilance / Drug Safety group. This position is within the Pharmacovigilance Department and reports to the Sr. Director, Drug Safety.

Responsibilities include:
  • Oversight of intake, evaluation, processing, reporting and tracking of SAE reports from clinical trials (and post-marketing, as applicable) to ensure compliance with global regulations and consistency across all Infinity products
  • Ensure safety data, including source documentation, are properly captured and maintained in the Global Safety System, per departmental SOPs
  • Act as the liaison for safety on multi-disciplinary teams and working groups; collaborate cross-functionally to ensure appropriate and consistent collection, handling and assessment of safety data
  • Develop and implement procedures and measures to ensure the highest quality, accuracy and timelines of departmental output; ensure compliance with SOPs and Global safety regulations
  • Assist in the development of study-related documents including: protocols, CRFs, and Investigator Brochures.
  • Oversee preparation of periodic safety reports, ad hoc safety analyses, and risk communications, as needed
  • Establish effective processes for outsourced activities, and manage vendor oversight activities
  • Manage safety review process and teams, as well as assist in addressing safety issues throughout the product lifecycle, including preparing data for signal detection analyses or ad hoc safety reviews
  • Hire, manage and mentor junior Drug Safety staff
  • Help ensure Drug Safety / Pharmacovigilance staff are updated on most current regulations relevant to Drug Safety organization.
  • Manage ongoing and ad-hoc projects in Drug Safety/Pharmacovigilance, and delegate tasks according to skill level
  • Collaborate with Sr. Staff in the Clinical group and cross-functionally to achieve objects of the department and the teams
  • Other duties as assigned
Requirements:

Five+ years of clinical and/or post-marketing safety experience and management experience; solid understanding of Argus or similar safety database; strong knowledge of applicable regulatory guidelines related to medical product safety; good MedDRA knowledge; hands-on experience with AE/SAE case processing; proficient with oral and written English, detailed-oriented, adaptable, good leadership and relationship building skills. Experience with ex-US clinical trials and post-marketing safety surveillance. Education: RN or BSN, Pharmacist, or PharmD or other health care professional background.

Re
quired

Skills Required

Experience

Infinity Pharmaceuticals, Inc. - 14 months ago - save job - block
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About this company
Infinity is an innovative drug discovery and development company dedicated to discovering, developing, and delivering best-in-class...