Pharmacovigilance Specialist-Registered Nurse

SafetyCall International is looking for a Registered Nurse to join our team as a Pharmacovigilance Specialist.

What you’ll do:

This individual will provide PV support for our clients who must comply with post-marketing adverse event (AE) reporting regulations for drugs, biological products, dietary supplements, medical devices, medical foods and cosmetics marketed in the USA and Canada. This support will include quality control, MedDRA coding, case assessments for reportability and the preparation of regulatory reports prior to delivery to our clients or direct submission to the FDA or Health Canada. The PV Specialist may also be a client liaison (account manager) to assigned client(s).

• Complete Individual Case Safety Report (ICSR) quality control (QC) to ensure accurate data collection and appropriate follow-up is completed by the front-line intake contact center positions.
• Assess ICSRs for individual adverse event terms signifying seriousness and expectedness relative to the product label while also referencing guidance documents provided by regulatory authorities on assessing seriousness.
• Examine ICSRs for reportability in the USA and Canada and determine the mandatory reporting requirements based on the product classification (e.g. 15-day, 30-day or Periodic). Report spontaneous ICSRs to health authorities using pharmacovigilance software.
• Apply appropriate MedDRA terminology and coding to the verbatim AE terms reported within ICSRs.
• Prepare documents of the appropriate regulatory forms (e.g. FDA Form 3500A or CIOMS I) for delivery to clients.
• Interact directly with clients on questions they have pertaining to all aspects of ICSR documentation, assessment and regulatory reporting.
• Perform ICSR reconciliation with clients and their marketing partners and exchange safety data when applicable.
• Review literature screening search results, identifying reportable ICSRs and other safety-related findings.
• Write or contribute to the preparation of aggregate reports (e.g. Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), Canadian Annual Summary Reports). This may include acting as the project coordinator, collating required information, incorporating reviewers' comments and finalizing the document.
• Assist with required pharmacovigilance processes, supporting preparation of SOPs, product safety reviews and literature reviews.
• Assist with batch data migration between PV databases.
• Review and exchange cases for compliance with safety data exchange agreements.
• Assist, as needed, with documentation of ICSRs.

Location: Remote from home. If located within 45 miles from the home office in Bloomington, MN; onsite attendance would be required every Tuesday.

Schedule: The Pharmacovigilance Specialist is a full-time, exempt position that will work 5 days/week, Monday-Friday, during normal business hours. The Pharmacovigilance Specialist may need to work hours outside of their normal schedule on occasion to accommodate workload.

What we’re looking for:

1. Active license as a Registered Nurse.

2. At least 2 years’ experience working in Pharmacovigilance, a Contract Research Organization (CRO) or other related scientific area; with specific experience working with Medical Devices, preferred.

3. Experience writing Periodic Adverse Drug Experience Reports (PADER) or Periodic Safety Update Reports (PSUR), preferred.

4. Strong knowledge and experience using computer programs and pharmacovigilance software such as ArisG, Oracle Argus or PV-Works.

5. Excellent written and oral communication skills with the ability to speak and write in a clear, concise, complete, and persuasive manner on a regular basis.

6. Ability to gather, analyze, and synthesize complex or diverse information.

7. Ability to exhibit sound and accurate judgment and make timely and accurate decisions.

8. Ability to prioritize and plan work activities in order to be efficient, complete all assigned projects in a timely manner and meet deadlines.

9. This position requires initiative, self-motivation, resourcefulness and the ability to work with little direction.

10. Strong attention to detail and spelling with the ability to accurately enter data with very few data entry errors.

Benefits and Pay

SafetyCall offers a robust benefits package including medical, dental, vision, accident, critical illness, hospital indemnity, pet, life and disability insurance plans; 401k with a match, paid time off, paid holidays, and CE/license reimbursement.

This is an exempt, salaried position with a starting range of $72,000-100,000/year. Pay will vary based on education and experience and will be discussed further in the interview process.