What are the responsibilities and job description for the Pharmacovigilance Analyst position at KOWA PHARMACEUTICALS?
Title: Pharmacovigilance Analyst
Reports To: Pharmacovigilance Manager
Department: Quality Assurance/Regulatory Affairs
Location: Montgomery, AL
This position is located at the Kowa Pharmaceutical America, Inc. corporate office in Montgomery, AL.
Applicants must reside within a reasonable distance of Montgomery, AL or be willing to relocate.
Job Responsibilities & Performance Standards:
- Contribute to the management of safety cases, including case intake/triage, data entry, quality review, medical review, and follow up activities
- Case management of reports from all sources
- Prepare case narratives and assign or evaluate appropriateness of MedDRA coding including follow-up updates
- Maintain a working knowledge of the safety database
- Support for SOP review, update, development
- Support for global document preparation and review (i.e., PBRERs)
- Conduct and assess literature searches
- Participate in global safety meetings (i.e., GET, GSC)
- Training (New hires, annual refresher, vendors)
- Support for regulatory submission preparation and review
- Support for Medical Information Inquiries
- Support for audit activities related to pharmacovigilance
- Reconciliation and Records Retention
- Maintain working knowledge of regulatory rules and regulations, including monitoring for new or changing regulation
- Acts as a back-up for Kowa global safety database local administrator
- Performs other duties as assigned
Experience and Skills:
- Required: Pharmacy Degree (Pharm.D. or R.Ph. with relevant clinical experience)
- Proficient in MS Office and Adobe Acrobat
- Prior work experience in Life Sciences preferred
- Experience with ARGUS preferred
- Must display significant analytical and clinical skills
- Requires excellent narrative writing skills
Other Considerations:
NOTE: The information presented, while not an exact or exhaustive listing, describes the work, performance standards, and qualifications typically required of positions of employees in this job. A specific position description or employee performance plan may differ as long as it is consistent with the core responsibilities, standards and qualifications for that job.
Kowa is committed to provide equal opportunity, employment, and advancement opportunities to all individuals. Kowa does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, protected veteran, pregnancy, status as a qualified individual with a disability, or any other characteristic protected by Federal, State, or Local Laws. Employment decisions at Kowa will be based on merit, qualifications, and abilities.