PURPOSE AND SCOPE:
Responsible for overseeing all aspects of adverse event case processing and reporting for assigned investigational and marketed products. Acts as a subject matter expert and may serve as a liaison to external contract safety providers, manufacturing, and other company personnel for safety issues. Works in collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality, and Medical Affairs.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Utilizes full understanding of drug safety to conduct complete clinical reviews of all domestic and foreign adverse event reports received for all Fresenius Medical Care products. Resolves a wide range of issues in creative ways.
Ensures consistency in the initial evaluation and assessment of adverse event reports from all source documentation for completeness, accuracy and legibility for valid case entry into Safety Database and succinctly summarizing case narrative.
Exercises judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, and listedness as per assigned product.
Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet, Important Medical Terms Sheet.
Produces Clinical Safety Queries as needed for clarification for reported events.
Serves as a PV Safety contact to other departments and Fresenius Medical Care-North America, Renal Therapies Group, LLC, licensing partners.
Interacts on a regular basis with Clinical Project Manager, Case Processing Manager, Medical Affairs, Quality, Regulatory Affairs, etc. to identify process improvement strategies and communicate Pharmacovigilance related project and Activity status updates.
Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc.) to resolve safety-related issues.
Performs quality related activities related to Field Alert Reporting, and CAPA.
Performs various assigned activities by the PV department leadership.
Performs pharmaceutical complaint Adverse Drug Experience and Drug Quality determinations and determines the level of investigation required.
Provides medical review as needed.
Performs authoring of aggregate reports as needed.
Performs MedDRA coding and maintains the MedDRA dictionary as needed.
Participates in signaling activities as needed.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Networks with senior internal and external personnel in own area of expertise.
Normally receives little instruction on day-to-day work, general instructions on new assignments.
May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
Mentors other staff as applicable.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Assists with various projects as assigned by direct supervisor.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor's Degree in nursing, pharmacy, or healthcare related field required.
Master's in Public Health, Pharm D., Medical Doctorate, Ph. D in Epidemiology or Public Health preferred.
EXPERIENCE AND REQUIRED SKILLS:
Minimum 5 - 8 years of Pharmaceutical industry experience or Drug safety experience in a clinical pharmacy, biotechnology, medical device, or pharmaceutical company. With a Master's Degree, only 3 years of experience required. With a PhD, no prior experience may be necessary.
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, 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.
Knowledge of GXP Scope (Good Pharmacovigilance Practice).
Demonstrated Good Documentation Practices.
Must proficient in MS Office Suite, Argus, and ArisG Safety system(s).
Excellent written and verbal communication skills.
Fluent in medical terminology.
Ability to interpret and follow regulatory guidelines.
Ability to review medical records to extract pertinent Drug Safety and Complaint data.
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.
O/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity