Safety Scientist

Axelon Services Corporation
Oct 06, 2016
Oct 19, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Job Title: Safety Scientist

Wallingford, CT

Job Description:

Lead cross-functional Medical Surveillance Teams (MSTs) and assigned subteams, such as Clinical Data Review (CDR) Teams, and participate in related PV and product-development subteam(s). Appropriately elevate issues impacting key MST activities, milestones, documents to the MST Chair. Mentor individuals in aspects of project management, drug development and MST requirements, as appropriate to meet overall MST/subteam needs. Create MST/assigned subteam meeting agendas and documentation of decisions, conclusions, timelines, milestones and action items in team minutes. Consistently ensures scientist verification of completion of action items to ensure that appropriate data, strategy, project milestones and individual member responsibilities are addressed and fully communicated. Influence the assigned team(s) functional members in tracking individual milestone activities. Periodic review and summary of pertinent safety-related literature, analysis of pre-determined core signal data. Provides advice and mentoring to scientists of summaries, evaluations and conclusions. Collaborate within and across company functions with appropriate disciplines to identify and ensure management of internal and external documentation and support when required. Apply knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Mentor individuals and teams on these applied learnings. Coordinate and integrate scientific, medical, and regulatory input from a variety of scientific sources and functional groups, as needed to support responses to ad hoc queries and HA commitments. Mentor and supervise scientist review and authoring of ad hoc queries.


* Experience writing narratives for study drug safety reports.

* Experience using a drug safety database to capture adverse events.

* Experience applying medical knowledge in a business context.

* Experience working in a post-marketing safety or clinical trial setting (i.e., CRO, pharmaceutical company and academic setting).

* Experience working in teams, including supporting other team members when necessary.

* Strong teamwork (with ability to lead a team) and prioritization skills to ensure that processes, procedures and best practices are consistent across GPV&E and that Regulatory requirements are met in a timely manner with high quality.

* Ability to make constructive recommendations to improve processes.

* Demonstrates the ability to multi-task, and flexibility to meet changing business priorities.

* Maintains an in-depth knowledge of the GPV&E Safety Database (CARES) and J-Review, and is able to query the systems to support the ESR scientist role.

* Ability to collaborate within multi-disciplinary team on drug safety-related issues including informing safety physicians and scientists within the therapeutic area on case-related issues.

* Ability to apply sound analytical thinking and database query skills to gather, review, summarize and evaluate critical information in a timely manner.

* Strong knowledge of SUSAR process, SOPs, conventions and health authority regulations worldwide, to ensure all safety information is accurate, integrated and current, and is submitted within regulatory timelines.

* Utilizes medical, scientific and clinical knowledge in reviewing safety-related documents (e.g. protocols, investigator brochures, product labels, relevant source documents) and incorporating key concepts to clearly present the reported events, and in turn, maintain patient safety.

* Possess medical writing skills to produce accurate, concise, medically sound expedited reports.


* Ability to support GPV&E Vision and Mission through an understanding of the impact and implications of daily work on all customers of the Expedited Safety Report Group.

* Medical and pharmaceutical knowledge (i.e., scientific understanding of the human body and its functions).

* Knowledge and understanding of Health Authority Regulations worldwide, how to access them and when to refer to them.

* High level of knowledge and experience using CARES, MedDRA, and J-Review.

* In depth Knowledge of computer applications and project planning skills.

* Mastery of GPV&E and R&D SOPs, drug safety coding conventions, and work.

* Provide technical support to GPV&E medical review safety physicians (MRSP) including review and interpretation of source documents.

* Participate in the evaluation of serious adverse event reports from spontaneous reports, clinical trials, non-clinical reports and scientific literature.

* Identify additional information required from investigators and collaborate with MRSP to prepare queries to obtain additional information.

* Utilize GPV&E database and J-Review to prepare contextual summaries for expedited safety reports.

* Review and comment on documents and line listings from GPV&E, other company departments, and other drug development/marketing partners and contractors.

* Ad Hoc member of Medical Surveillance Team.

* Perform Analysis of Similar Events for potential DILI and events of special interest.

* Serve as a resource for GPV&E information and help develop and participate in and/or lead teams involved with developing or revising GPV&E SOPs.