Job Summary
Cognizant is seeking a detail-oriented and motivated Pharmacovigilance Specialist to support safety case processing, case assessment review, and PMDA reporting activities for global pharmaceutical clients. The successful candidate will be responsible for evaluating adverse event reports, performing J-Assessments, managing safety data within Argus/Argus J, and ensuring compliance with regulatory requirements and quality standards.
This role requires strong pharmacovigilance knowledge, attention to detail, and the ability to work effectively in a fast-paced, client-focused environment.
Key Responsibilities
Safety Case Processing & Assessment
- Receive and review safety case reports from multiple sources, including healthcare professionals, medical representatives, call centers, clinical trials, post-marketing surveillance programs, literature, and other reporting channels.
- Perform case assessment and review activities in accordance with client requirements, SOPs, and regulatory guidelines.
- Conduct duplicate case searches and reconciliation activities as required.
- Open, process, and maintain safety cases routed through the global safety database/system.
- Ensure accurate and complete data entry within Argus and Argus J.
J-Assessment & PMDA Reporting
- Perform J-Assessments in Argus J in accordance with Japanese regulatory requirements.
- Prepare and generate PMDA submission reports outside of Argus when required.
- Generate PMDA submission XML files using the designated ICSR Creation Tool for cases where PMDA reports cannot be generated directly through Argus J.
- Maintain submission-related documentation and ensure compliance with reporting timelines.
- Apply local product labeling information for each adverse event by referring to approved product labeling documents.
Operational Excellence
- Collaborate closely with Team Leads and cross-functional teams to support operational activities.
- Provide status updates and progress reports to the Operations Manager as required.
- Ensure timely completion of assigned activities while maintaining quality and productivity standards.
- Support process improvement initiatives and contribute to operational efficiency.
- Maintain compliance with client, regulatory, and internal quality requirements.
Required Experience
Mandatory
- Minimum 1 year of experience in Case Assessment Review, Safety Case Processing, or Pharmacovigilance operations.
- Experience working with safety databases such as Argus or Argus J.
- Experience reviewing and processing adverse event reports.
Preferred
- Minimum 2 years of Pharmacovigilance experience within a global pharmaceutical company, CRO, or healthcare organization.
- Experience with Japanese Pharmacovigilance regulations and PMDA reporting requirements.
- Experience performing J-Assessments and managing regulatory submissions.
Educational Qualifications
One of the following qualifications is required:
- Bachelor's Degree in Life Sciences or Non-Life Sciences; or
- Nursing qualification/license; or
- Degree in Pharmacy, Medicine, Allied Health Sciences, or related healthcare disciplines.
Language Requirements
Japanese
- Native-level Japanese proficiency; or
- Japanese Language Proficiency Test (JLPT) N1 or equivalent.
English
- Business-level English proficiency (Reading, Writing, and Listening).
- TOEIC score of 700 or above preferred.
- Overseas education or study-abroad experience is an advantage.
Required Competencies
- Strong analytical and problem-solving skills.
- Excellent attention to detail and accuracy.
- Strong verbal and written communication skills.
- Ability to work effectively in a team environment.
- Good organizational and time-management skills.
- Demonstrated learning agility and willingness to acquire new skills and knowledge.
- Ability to manage multiple priorities while maintaining high-quality standards.
- Commitment to compliance, quality, and patient safety.
Acerca de Cognizant
Cognizant (Nasdaq: CTSH) es un creador de soluciones de IA y proveedor de servicios tecnológicos que conecta la inversión en IA con el valor empresarial mediante el desarrollo de soluciones de IA full‑stack para sus clientes. Su profundo conocimiento de la industria, junto con su experiencia en procesos e ingeniería, permite incorporar el contexto único de cada organización en sistemas tecnológicos que amplifican el potencial humano, generan resultados tangibles y mantienen a las empresas a la vanguardia en un entorno en constante cambio. Más información en cognizant.ai o @cognizant.
Información adicional de empleo
La información de compensación es precisa a la fecha de esta publicación. Cognizant se reserva el derecho de modificar esta información en cualquier momento, sujeto a la legislación aplicable.
Es posible que se requiera que los solicitantes asistan a entrevistas en persona o por videoconferencia. Además, es posible que se requiera que los candidatos presenten su identificación actual emitida por el estado o gobierno durante cada entrevista.
Cognizant es un empleador que ofrece igualdad de oportunidades. Tu solicitud y candidatura no serán consideradas en base a raza, color, sexo, religión, credo, orientación sexual, identidad de género, origen nacional, discapacidad, información genética, embarazo, condición de veterano o cualquier otra característica protegida por las leyes federales, estatales o locales.
Si tienes una discapacidad que requiere adaptaciones razonables para buscar una vacante de trabajo o enviar una solicitud, puedes enviar un correo electrónico a [email protected] con tu solicitud e información de contacto.
