Drug Safety Specialist II

Proclinical is advertising a vacancy for a Drug Safety Specialist II position with a leading pharmaceutical research company. The organization prides itself on its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. Based in the company's California office, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the drug safety field.

Job Responsibilities:

• Contributing to the full lifecycle of safety data retrieval activities data query, authoring, validation, and publishing reports.
• Executing validation protocols.
• Reviewing, extracting, and accurately entering AE data from ICSR reports from both investigational and post-marketing products.
• Interpreting case-related information, including medical conditions, lab results and procedures, as well as compiling complete narrative summaries.
• Reviewing, entering, and verifying follow-up information for cases and determining significant information.
• Performing reviews of ancillary documentation accompanying ICSR reports and identifying pertinent information for incorporations into the case narrative.
• Correctly identifying cases requiring targeted follow-up, determining relevant follow-up required, and preparing follow-up queries.
• Setting work priorities and direction with input from Manager.
• Interacting with other Drug Safety functional areas to process adverse events efficiently and reliably.
• Liaising with clinical departments, affiliates, marketing or contract research organizations (CROs) as needed on safety data issues, such as obtaining clarification or follow-up information.
• Meeting specific data and quality targets for case handling.
• Remaining current with cases, handling SOPs, guidance documents, and database technology.
• Organizing workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR.
• Ensuring departmental workflow processes and timelines are followed.
• Working with Submissions Team to properly identify global regulatory reporting requirements, especially for sponsored clinical trials reports.
• Taking responsibility over data reviews and ensuring that data entries made by Safety Coordinators are correct.

Skills and Requirements:

• Knowledge/experience of computer systems, data processing, and enterprise software applications.
• An understanding of relational databases and reporting tools.

• An understanding of current regulations within drug safety.
• A solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports.
• Experience in safety database and data entry.
• An understanding of medical terminology and the ability to summarize medical information is preferred, along with the ability to assess data and understand medical/safety implications.
• Knowledge and experience with safety reporting and regulatory compliance, and experience with international safety reporting/regulations is preferred.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at + 267 435 8600 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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