POSITION FEATURES:
 

This is a fully remote position.

PURPOSE AND SCOPE:

Responsible for overseeing all aspects of adverse event case processing and reporting for assigned investigational and marketed products. May serve as a liaison to external contract safety providers and company personnel for safety issues. Works in collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality, and Medical Affairs. 

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Developing professional expertise, applies company policies and procedures to c onduct complete clinical reviews of all domestic and foreign adverse event reports received for all FMCRTG,LLC.

• 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 FMCRTG,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 as assigned

• Performs various assigned activities by the PV department leadership.

• Normally receives general work instructions on routine work, detailed instructions on new projects or assignments. Work is reviewed for soundness.

• Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.

• 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. 

EDUCATION :

• Bachelor's Degree in nursing, pharmacy, or healthcare related field required. 

EXPERIENCE AND REQUIRED SKILLS:

• 2 - 5 years of drug safety experience in a biotechnology, and/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, 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 be proficient in MS Office Suite, Argus, ArisG Safety system(s).

• 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 work both independently and in a collaborative team setting.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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