Associate Director, U.S. Case Processing

How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.
Position Purpose:US Lead in processing adverse event (AE) cases received by Novartis Consumer Health (NCH), Over-the-Counter (OTC) Drug Safety and Pharmacovigilance (DSP) US to meet Novartis internal requirements and legal obligations on AE case processing, analysis and reporting to health authorities.Responsibilities:
Leads all applicable Drug Safety Operations-OTC team members in the maintenance, processing, and integrity of case files. Leading team responsibilities that include the following:Perform daily responsibilities in accordance to all applicable SOPs, conventions and company policies
Databasing, as required, assessments and processing of all initial and follow-up medical reports in the Global Safety Database ARGUS
Review and medically evaluate relevant drug safety data/information while alerting Medical Safety Experts (MSE) of potential serious case assessments/case trends
Medical coding of Adverse Events with the MedDRA dictionary
Product coding with the WHO dictionary
Update case records as applicable
Obtain necessary medical case follow-up as applicable
Assist with communications to call center regarding case follow-up needs, call center database conventions and pointing out problematic topics issues while alerting Novartis management of their findings
Maintain both paper and electronic documents maintained in all applicable applications and case files according to all applicable SOPs/departmental conventions
Support in the review of QA (Annual Product Review Reports and Lack of Efficacy Reports) and US Periodic Safety reports
Support in literature searches for medical inquires
Reconciliation of cases (CRS and ARGUS, shared products Pharma)
Assist in development of SOPs, Working Procedures and Drug Safety conventions
Assist in the creation of drug safety relevant product information
Refer all medical drug safety inquiries to the appropriate Novartis medical team members
Process cases with high quality in a productive and orderly manner through the workflow
Assist with special projects, as required and instructed (Example: Medical quality assurance of processed data and internal drug safety procedures, attendance of all applicable departmental meetings, development of all applicable drug safety training, etc.)Qualifications
Position Requirements & Education:
B.A. or B.S. required
Degree in pharmacy (RPh, PharmD), or nursing (RN, LPN) or Physician's Assistant or Nurse PractitionerExperience & Knowledge:
Pharmacovigilance, 8-10 years experience in the pharmaceutical industry
ARGUS Drug Safety Database preferable. Equivalent database experience acceptable
MedDRA coding and the WHO dictionary for products
OTC experience is preferable
Medical background, Bachelor degree in nursing or pharmacy
Computer literate
Professional phone skills
Excellent organizational, written and oral skills
Ability to meet and maintain very tight deadlines while maintaining organization and punctual work ethics
Must work well with multiple team members at one time
Maintain a professional and discrete attitudeBehavior
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????High ethical and moral attributes
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Open and honest
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Ability to quickly adjust to changing priorities
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Ability to work with minimum supervision
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Ability to work under pressure and meet deadlines
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Ability to handle multiple projects at once
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Ability to meet and maintain very tight deadlines while maintaining organization and excellent punctual work ethics.
??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Highly responsible, with the ability and willingness to initiate and demonstrate autonomy of thought and action.
Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.
REQUIREMENTS
Please see Job Description