Director, Clinical Safety & Pharmacovigilance Job in Princeton 08540, New Jersey Us
Job Description:
Enters spontaneous post-marketing adverse event (AE) data and immediately reportable events from clinical trials into the safety database. Provides support to Clinical Drug Safety Associates for project specific administrative tasks, including electronic and hard copy records management, data entry activities, and metrics collection. Takes accountability for the accuracy of AE data entry information.
• Responsible for processing incoming AE information, including:
- Performs triage and assigns priority to time sensitive and project critical incoming events and classifies them according to regulatory reporting criteria.
- Confirms presence of adequate patient, medical and adverse event information needed to perform case evaluation.
- Reviews clinical study adverse events for accuracy, integrity, and consistency according to project-specific guidelines.
- Performs electronic or manual preliminary adverse event coding, as necessary, and in accordance with Standard Operating Procedures.
- Reviews relevant source documents for consistency and verification of adverse event data.
- Prepares drug safety narratives, according to approved template.
- Interacts with CSPV team members to ensure correct and timely adverse event processing.
- Adheres to required timelines for completion of adverse event report.
- Maintains a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.
- Routing report information to appropriate Clinical Safety and Pharmacovigilance (CSPV) personnel for continued AE case processing.
- Assisting in generation of database queries for AE listings.
• Documentation of outgoing AE information, including:
- Preparing reports as directed by Clinical Safety Pharmacovigilance.
- Generating predetermined safety data reports.
- Performing QC activity as directed by CSPV managers.
- Transmitting/distributing reports.
- Assisting in tracking and confirmation of report destination.
• Maintaining adequate records, including:
- Assisting in follow-up tracking as mandated by SOP014.
- Assisting in records location and retrieval.
- Assisting in Document Control Room file maintenance according to company and CSPV policy.
- Assisting in the creation of entry specifications, report specifications, and database mapping documents as directed by CSPV associate.
• Supports clinical projects, including:
- Maintaining up-to-date knowledge of protocol and scope of work for assigned projects.
- Communicating monthly adverse event report totals, product safety issues, and concerns to CSPV management.
- Identifying and communicating data entry issues to CSPV management in a timely manner.
- Providing process improvement suggestions.
- Managing the preparation and posting of monthly reports to the Clinical Teams and CSPV Web site.
- Ensuring the safety database is maintained as necessary to track documentation.
- Tracking critical document submission dates (e.g., 15-day safety reports) as a time management tool for department.
- Organizing and maintaining an inventory of safety reports for use by department.
Knowledge, Skills, and Competencies
• Requires knowledge of standard query language and knowledge of industry terminology.
• Familiarity with drug safety databases
Skills
• Ability to use software applications to track databases.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Excellent command of written and spoken English
Competencies
• Proven ability to work in a team environment
Physical Demands and Work Environment
See document Physical Demands and Work Environment for requirements.
Education and Related Experience
• Bachelor degree in a scientific field, preferably in the health sciences area (e.g., Nursing, Pharmacy)
• 2 years of data entry experience in the pharmaceutical industry.
Apply online at: https://2xrecruit.kenexa.com/kr/cc/jsp/public/EmailJobDetail.jsf?npi=592BD0535B5F57261EE563929442C841rand=875DF583AB8C41C2B235C516E540C3B1
Company Description:
Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of Otsuka's ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of its patients around the world with a strong commitment to research and development in the areas of cardiovascular, respiratory, renal and neuroscience systems, and to treat cancer and ophthalmic disorders.