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.
- 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
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.
Infinity Pharmaceuticals, Inc. - 20 months ago
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