HCN Healthcare Recruiting

Position Summary:
The Clinical Safety Specialist will support complaint handling and adverse event activities related to medical devices manufactured and/or distributed by NeoVista Incorporated. This person will be responsible for ensuring that Serious Adverse Event (SAE) and Unexpected Adverse Device Events (UADE) are submitted in a timely manner and are reported consistent with worldwide reporting regulations. This person will review incoming event notifications for reportability and performs follow-ups as required.

- Collect information on adverse events via phone, e-mail or fax
- Summarize information obtained to facilitate accurate data entry.  Prepare a clear and concise narrative of the event.
- Identify clinically significant information missing from initial reports and ensure its collection
- Prepare follow-up correspondence in consultation with medical staff
- Enter domestic adverse event data (from both spontaneous and clinical trial reports).  Codes according to controlled vocabularies.
- Search database to prevent duplicate entries and make necessary corrections as per regular query process.
- Review and query electronic case reports following data entry.
- Participates in weekly team meeting and supports reportability decisions.
- Identifies and properly assesses serious adverse events and new trends in adverse events and advises Project Management accordingly.
- Works in concert with company Data Monitoring Committee.
- Responsible for taking appropriate steps to ensure patient information is maintained and communicated in a confidential manner.
- Conducts literature searches as applicable.
- Leads projects related to retrospective reviews of complaint data.
- Interacts with Project Managers to resolve CAPAs.
- Serves as liaison between all internal and external personnel involved with an adverse event, including, internal departments i.e. Regulatory affairs, legal, clinical, data management
- Perform related duties as requested 
Employee must be cognizant that failure to obtain results or arrive at appropriate decisions puts business at risk of regulatory action from governmental agencies. Assists in FDA and Notified Body inspections.

Physical Requirements:
-  Hospital and R&D environment.

Minimum Qualifications, Education and Work Experience:
- 2+ years of experience in the pharmaceutical/medical device industry
- Experience in Drug Safety, Pharmacovigilance or Safety Surveillance is preferred Experience with data management and coding
- Familiar with adverse event/experience regulations regarding spontaneous and clinical trial reports
- Computer literacy, familiar with data entry conventions and actions
- Adaptability to changing regulatory environments.
- Must exercise good judgment and operate with large degree of independence regarding routine and non-routine assignments.
- Must be willing to travel (approximately 10% - 20%).
Education/Degree:  Bachelor’s Degree, Registered Nurse (RN) or Pharmacist or similarly certified health professional
Preferred Qualifications, Education and Work Experience:
- Knowledge of FDA regulatory requirements and ICH guidelines.
- Experience working with ophthalmic devices in a surgical environment
- Experience working with radiation devices a plus.
- Working knowledge of current FDA Quality Systems Regulation, ISO 13485:2003, CMDR and the EU Medical Device Directive required.
APPLY NOW FOR IMMEDIATE CONSIDERATION