Senior Clinical Safety Associate Job in Princeton 08540, New Jersey Us

Job Description:

This position will be responsible for the collection, documentation and processing immediately reportable events from clinical trials and all adverse events from post marketing spontaneous reports in accordance with Global Pharmacovigilance Regulations and the company's Standard Operating Procedure. Closely Monitor the safety profile of assigned products, both in development and post-marketing.  Actively contributes to the preparation of aggregate and ad hoc safety reports.

Qualifications

Job Responsibilities

·         Maintains accurate and complete knowledge of all investigational and marketed products being monitored by Otsuka, co-marketers, co-sponsors, and/or affiliates.

·         Collects, documents, and processes adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance.  This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check

·         Initiates follow-up calls to investigative sites and spontaneous reporters, as needed, to retrieve missing AE information, according to SAE reporting requirements, regulatory guidelines, and department SOPs.

·         Conducts periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision

·         Maintains a thorough understanding of internal and external interactions, and scope of work assigned to the department

·         Assists with conducting literature searches for assigned products

·         Drafts safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports

·         Supports the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks

·         Serves as resource for CS PV Associates and Assistants

·         Maintains effective working relationships with Investigational study site staff

·         Provides training on the technical and operational aspects of programs to CS PV team members (and other OPDC staff as appropriate).

·         Communicates product safety issues to team members in a timely manner.

·         Utilizes regulatory and GCP knowledge to assist team members in the assessment of adverse event reports

·         Represents CS PV at interdepartmental team meetings

·         Represents CS PV at meetings conducted with licensing partners, agents, CROs, and clinical site investigators

·         Interact on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues

·         Reviews and provides input on protocols, case report forms, investigator brochures, package inserts, and NDA/PLA documents

·         Contributes to presentations, discussions, and data summaries on safety issues at meetings with external groups such as licensing partners, agents, contract research organizations, independent safety monitoring committees, and clinical site investigators

Knowledge, Skills, and Competencies

·         Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial and post-marketing environments desirable

·         Requires a solid understanding of medical and clinical practices, with a strong understanding of medical concepts and terminology

·         Working knowledge of MedDRA dictionary with relevance to adverse event coding

Skills

·         Strong computer skills with demonstrated experience in working with the Microsoft Office (Word, Excel, PowerPoint, and Outlook).

·         Knows how/when to apply organizational policy or procedures to a variety of situations

·         Excellent verbal and written communication skills

·         Time management skills

Physical Demands and Work Environment

·         Travel (approximately 10%)

·         See document Physical Demands and Work Environment for further requirements.

·         Requires extensive use of keyboard, requiring repetitive motions with fingers and sitting for prolonged periods of time.

Education and Related Experience

·         RN, LPN, or Pharmacist with 3 years or more of drug safety experience AND additional clinical or pharmaceutical experience

·         OR

·         BS with 5 years or more of drug safety experience in the pharmaceutical industry

Please send your Resume to: Daniela.TC-Vendramini@otsuka-us.com

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.