Responsible for narrative writing and case processing of serious adverse event (SAE) data within department timelines assuring compliance with SOP’s and FDA regulations for the reporting of adverse events to regulatory agencies. Acts as mentor for junior staff members and performs Quality Control on other team members work. Ability to work independently and prioritize workload.
Key Accountabilities/Core Job Responsibilities:
- Support all Drug Safety activities for Pharmacyclics sponsored trials and programs, to include:
- use medical background and experience to integrate case-related information including medical conditions, lab results and procedures to write comprehensive SAE case narratives
- generate clinically relevant SAE queries to obtain missing information
- act as Team Lead for products/studies as applicable
- represent Clinical Drug Safety as a member of study management teams
- assist in the oversight of CRO and business partners to ensure adherence to safety management plans and data exchange agreements
- Assist in preparation of s afety related sections and associated documentation for clinical and regulatory documents (including clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety, European clinical expert reports)
- Assist in the creation/revision of department procedures and policies
- Assists with Safety Science pharmacovigilance projects as necessary
- Performs other duties as requested.
- Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
- Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
- Outstanding communication skills (verbal and written).
- Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
- Ability to manage multiple projects in a fast-paced environment.
- Collaborate effectively with the study team, cross-functional team members, and external partners.
- Previous Drug Safety/Pharmacovigilance experience of at least 3-4 years in a global environment.
- At a minimum, Bachelor’s level degree in life sciences, pharmacy, or nursing. RN, PharmD, or MD strongly preferred.
- Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
- Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
- Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
- Familiarity with common Safety databases (e.g., Arisg, AERS, Argus, etc.) necessary.
Pharmacyclics, Inc. - 22 months ago