Description
Description:The Senior Drug Safety Associate is responsible for overseeing and performing specific tasks related to serious adverse event (SAE) processing for assigned investigational product. This individual may serve as a liaison to external contract safety providers, CROs, and company personnel for safety issues, working in close collaboration with colleagues from Regulatory Affairs, Medical Affairs, Data Management, and Clinical Operations.
Main Responsibilities and Accountabilities:
*Conduct complete review of all domestic and foreign SAE reports for all The 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 and Abilities:
*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.
To find out more about Real please visit www.realstaffing.com