Description
Responsibilities:*Conduct complete review of all domestic and foreign SAE reports for all Companies investigational products.
*Ensure consistency in the initial evaluation and assessment of SAE reports and source documentation for completeness, accuracy and legibility.
*Write case narrative for SAE reports and prepare MedWatch, CIOMS, and other forms, as needed.
*Perform medical and quality reviews of completed SAE reports received from contract drug safety vendors (CROs) and transmit reports to business partner per safety data exchange agreement timelines.
*Exercise judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing SAE case assessments and reviews.
*Generate appropriate queries to sites and/or contract drug safety vendors (CROs) to complete and clarify SAE case information, and exercises judgment in determining when cases are complete and ready to close.
*Collaborate with Regulatory personnel on a regular basis to communicate the reporting of SAEs requiring submission to Regulatory Authorities and to ensure reporting is appropriately performed per required timelines.
*May assist in the preparation of safety sections for regulatory documents and the development of Safety forms, standard operating procedures, and process guidelines.
*May participate in signal detection activities.
*Collaborate, as needed, with other cross-functional teams (i.e. Clinical Operations, Data Management, Biometrics, etc).
*Participate in meetings and teleconferences, as needed, with internal cross-functional teams, CROs, and business partner.
*Support Drug Safety Manager with other SAE reporting and Safety Operations.
*Delivers weekly or monthly metrics to supervisor efficiently, accurately and within agreed-upon timelines.
Education and/or Experience:
*Registered Nurse or Medical Doctor with a minimum of a Bachelor's degree in nursing, pharmacy, or in a health-care related field required.
*Minimum of three years drug safety experience in a biotechnology or pharmaceutical company.
*Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
*Familiarity with safety databases, data entry platforms, adverse event data collection process, 15-day safety alerts, submissions of safety updates to the regulatory bodies including FDA/EMA, Pharmacovigilance Safety Data Exchange Agreements, Risk Evaluation and Mitigation Strategies, Medications Guides, pre-approval process and post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development.
Qualifications:
*Must possess an RN or MD licensure (US or foreign).
*Experience in SAE case-processing and with safety databases preferred.
*Basic knowledge of MedDRA coding.
*Knowledge of cGXPs
*Demonstrated Good Documentation Practices
*Must be proficient in MS Office Suite.
Other Skills:
*Excellent written and verbal communication skills.
*Fluent in medical terminology.
*Ability to interpret and follow regulatory guidelines.
*Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
*Ability to multi-task and work with tight deadlines.
*Ability to work both independently and in a collaborative team setting.