Pharmacovigilance Analyst
KOWA PHARMACEUTICALS
Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, Alabama, is focused primarily in the area of cardiometabolic diseases. Established in 2008, Kowa Pharmaceuticals America, Inc. focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products and business development activities.
A legacy of trust. A future of care. Established in 2008, Kowa Pharmaceuticals, Inc., is committed to developing and delivering safe, effective solutions in the field of cardiometabolic therapeutics. We do this by maintaining high ethical and professional standards—and it all starts with people. By empowering our employees to live this mission, we can create a healthier vision for the future.
Our Mission Is To:
Develop and commercialize safe, effective and high-quality pharmaceutical products at a reasonable cost
Be customer focused and provide the highest level of customer support and service
Conduct all business with honesty, professionalism and integrity
Maximize human capital by hiring, training and retaining the very best employees
Aggressively seek new marketing opportunities and maximize the potential of current products
A legacy of trust. A future of care. Established in 2008, Kowa Pharmaceuticals, Inc., is committed to developing and delivering safe, effective solutions in the field of cardiometabolic therapeutics. We do this by maintaining high ethical and professional standards—and it all starts with people. By empowering our employees to live this mission, we can create a healthier vision for the future.
Our Mission Is To:
Develop and commercialize safe, effective and high-quality pharmaceutical products at a reasonable cost
Be customer focused and provide the highest level of customer support and service
Conduct all business with honesty, professionalism and integrity
Maximize human capital by hiring, training and retaining the very best employees
Aggressively seek new marketing opportunities and maximize the potential of current products
Montgomery, Alabama
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 Purpose:
The Pharmacovigilance (PV) Analyst is responsible for adverse event reporting activities including data entry, quality control (QC), follow-up, medical review, and documentation. Responsible for and supports various PV activities. This will involve liaising with global pharmacovigilance colleagues to ensure that the events have been entered correctly and submitted successfully to regulatory authorities within regulatory compliant timelines. The PV Analyst will also be required to collaborate on SOP preparation, review, and updates.
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:
Travel (including international travel from time to time) to visit partners and attend relevant conferences or meetings may be required. Candidate must be willing to travel up to 20% of the time. Flexibility in scheduling travel also required. This position is eligible for a remote work schedule governed by Kowa’s Remote Work Policy. Remote work is available at the discretion of management and business need. Based on the job description, this position requires occasional in-office work days at the corporate office located in Montgomery, AL.
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.