Description:
The Associate Director, Safety Operations is responsible for pharmacovigilance activities involving the Company's products and/or clinical trials. The Associate Director, Safety Operations will manage individual adverse events (AE) cases, including review, processing and evaluation of safety reports. Additional duties include participating in the safety surveillance program for investigational products, providing line management to Drug Safety Operations team members as well as managing technical functions at a cross functional level.
Roles and Responsibilities for the position
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- Oversee the proper and timely collection and reporting of AE information from all sources.
- Assist in the preparation and management of aggregate safety reports (e.g. IND safety reports, DSURs, PSLLs etc.).
- Perform medical review of AEs/SAEs from clinical trials, interfacing with reporters as needed.
- Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, ICFs, CSRs, IBs and other documents as needed.
- Review of protocols, case report forms, guidelines, CSRs and manuscripts as requested.
- Assist with the development and maintenance of pharmacovigilance related SOPs, policies and work instructions.
- Create and track case processing metrics for internal monthly safety reports.
- Contribute to regulatory authority submissions by reviewing safety data and assisting in the preparation of relevant sections.
- Participate in regulatory and inspections/audits as it relates to pharmacovigilance activities.
- Collaborate cross functionally with other departments including clinical, biostatistics, data management, clinical operations and regulatory affairs with respect to safety related issues.
- Liaise to provide drug safety oversight of processes overseen by vendors.
- Participate in addressing drug safety-related questions from Regulators or to support Company internally.
- Manage, guide and train direct reports.
Required Qualifications and Preferred Background
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- Required:
- Health science degree: Nursing (RN, BSN, MSN or NP), RPH, PharmD, PA or MD.
- Experience in the management of safety information originating from clinical trials and post-marketing sources.