Drug Safety Specialist


HLM Clinicals is currently seeking a Drug Safety Specialist with Medical Information experience for a client in Princeton, NJ
This position will supervise other Safety Associates. And will report to Head of Drug Safety and Pharmacovigilance.

Job Description & Responsibilities
The Drug Safety Specialist is responsible for the management of daily processing of Product Complaints to ensure compliance with FDA regulations as well as internal SOP's.
The specialist is also responsible for the management and maintenance of receipt of Adverse Drug Events, Product/Medical inquiries and Product Complaints and related processes to ensure compliance with FDA regulations as well as internal SOP's Product Complaints.
Collects information from healthcare professionals or consumers for spontaneous product quality complaints.
Conducts follow-ups to ascertain further information and or to obtain product samples.
Work with QA for analysis as required
Creates Acknowledgement letters, follow-ups and provided Response letters to complainants
Communicate with regulatory agencies, health care professionals and consumers on marketed products as required.
Supervises the collection of information from consumers and healthcare professionals for ADE and Product/Medical inquiries
Address inquiries as necessary
Review and follow up with QA for inquiries that are pending responses to ensure timely response

Job Qualification Requirements
Bachelor’s Degree preferably in Life Science, Nursing, Pharmacy with 3+ years of pertinent experience
Microsoft Office, Outlook, Trackwise (preferred)
Candidate must have effective leadership skills, decision making skills, superior customer service attitude for handling consumers, healthcare professionals and colleagues.
Always maintaining a positive team player attitude and proactive in improving processes and helping others


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