Product Safety Investigator (closed)
Duration: 6 months Responsible for the telephone and written communication
with physicians, other health-care professionals, sales personnel, and patients,
in response to spontaneous and clinical trial Adverse Drug Reactions, Medical
Devices Experiences, and technical reports associated with products. Report to
the Manager, Product Safety. Other relationships include interaction with
necessary parties with regard to product safety and surveillance issues.
External relationships include interaction with regulatory institutions such as
the FDA and IPS. Provide medical and technical information to Health-Care
professionals and patients relating to product safety. Conduct investigations
into adverse drug and device reports with products with respect to applicable
Federal regulations (IND, NDA, MDR, GMP) and internal Standard Operating
Procedures. Triage adverse medical events and malfunction reports with respect
to FDA report ability (ie. 7 day, 15 day, MDR). Submit spontaneous and clinical
trial reports of deaths and serious events to IPS per current agreement.
Responsible for preparation of NDA, MDR and IND Accelerated Safety Reports.
Prepare and submit product report files foreclosure as outlined in Corporate
Standard Operating Procedures. Communicate with complainant / NNPI personnel as
to status of complaint investigation, course of action, and the need for
additional medical and/or supplementary information relevant to the report.
Communicate with NNAS Quality departments (Drug and Device) as to the status of
product analysis and the need for additional information relevant to the report.
Participate in clinical development teams as necessary to assure proper
collection and reporting of clinical study adverse event data. Assist manager
with providing technical direction to Product Safety & Surveillance support
personnel. Responsible for after-hours rotational emergency medical calls.
Assist manager with Product Safety & Surveillance Sales Force presentations.
Complete special projects as required. Minimum Requirements: * Registered
Nursing license or Registered Pharmacist required. * At least 2 years of prior
experience required, specifically in pharmacy practice, clinical or product