The Drug Safety Specialist is responsible for overseeing specific aspects of adverse event processing and reporting for assigned investigational and marketed products. This individual may serve as a liaison to external contract safety providers and company associates for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs. PLEASE REFER TO JOB CODE 1412 WHEN APPLYING FOR THIS POSITION.
Education and/or Experience: :
- Essential Duties and Responsibilities include the following. Other duties may be assigned.:
- Completes data entry of individual case safety reports (ICSRs) from clinical trials and post marketing sources.
- Conducts complete clinical reviews of all domestic and foreign adverse event reports for all Acorda investigational and marketed products.
- Ensures consistency in the initial evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility.
- Performs active follow-up, including both written and verbal communication with healthcare professionals and consumers.
- Interprets source documentation including relevant medical conditions, lab results and procedures to compile complete and accurate narrative summaries.
- Exercises judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, causality, listedness and reporting requirements.
- Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet.
- Produces Clinical Safety Queries as needed for clarification of reports.
- Serves as a Safety Liaison contact to other departments and Acorda licensing partners.
- Interacts on a regular basis with Clinical Project Mgrs, Case Processing Mgrs, and Medical Affairs to identify process improvement strategies and communicate project status updates.
- Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues.
- Bachelor's degree in Nursing, Pharmacy or health-care related field required.
- Minimum of two to four 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 the following: safety databases, data entry platforms, adverse event data collection process, case processing unit, call center, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, 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.
- Basic knowledge of cGXPs.
- Working knowledge of Demonstrated Good Documentation Practices.
- Fluent in medical terminology.
Certificates, Licenses, Registrations::
- Must be proficient in MS Office Suite.
At least one of the following: LPN, RN, RPh, PharmD, P.A. or MPH is required.
Other Skills and Abilities::
Location - Corporate:
- Excellent written and verbal communication skills.
- 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 work both independently and in a collaborative team setting.
- Must demonstrate a keen attention to detail and timelines.
This position requires working on-site 5 days per week in our Corporate Office located in Ardsley, NY.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- There is minimal travel for this position; the average travel is 5-10 with some variation based upon the demands of the business imperatives.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Acorda Therapeutics - 2 years ago