What are the responsibilities and job description for the Product Safety Specialist - Global Compliance position at Pharma Search Partners LLC?
Job Overview
This role is an opportunity to join Pharma Search Partners LLC as a Product Safety Specialist, focusing on global compliance with regulatory standards and guidelines. You will be responsible for overseeing the entire product safety process, ensuring consistency of case records and documentation, and interacting with various stakeholders including healthcare professionals, consumers, and co-marketing partners.
Key Responsibilities:
- Adverse Event Information Collection: Collect, process, track, and distribute adverse event information from various sources, ensuring accuracy and completeness.
- Collaboration with Healthcare Professionals: Interact with healthcare professionals and consumers regarding post-market adverse experiences, and clinical investigators and their staff regarding AE's from clinical trials.
- Project Management: Assist in projects requiring review and assessment of medical information obtained or related to adverse event reports, cumulative reports, or international regulatory reports and requests.
- Data Quality Assurance: Set standards for data collection and distribution processes; coordinate with others to assure policies are implemented, and reviews data to verify accuracy and completeness of medical information and associated documentation.
Requirements:
- Clinical Medicine Application: Apply clinical medicine principles to patient care.
- Medical Terminology and Standards: Possess knowledge of medical terminology and standards of patient care.
- Communication Skills: Effective communication and medical writing skills are essential.
- Regulatory Knowledge: Familiarity with International and US Regulations for reporting Adverse Events for Investigational and Marketed products.
- Experience and Education: Minimum 5-7 years of experience in an industry application of clinical medicine/pharmacy, including a minimum of 3 years of experience in International Product Safety. A Bachelor's degree in a medical field with RN or RPh licensure, or PharmD/MD degree is required.
