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Astellas is announcing a Safety Scientist/Principal Safety Scientist, Oncology opportunity in our Deerfield, IL location.

Under the general direction of the Medical Function Head, the PSP Medical Safety Analyst will support the PSP Therapeutic Area Lead physician in the tasks and activities for an assigned therapeutic area. Armed with sizeable scientific knowledge, analytical methodology, and project management skills, this individual will be critical to the success of a Therapeutic Area safety business unit by ensuring that pre- and post marketed products are adequately supported from a safety standpoint.

Essential Job Responsibilities

Analysis of pre and post-marketing data to support ongoing safety surveillance for APUS products, including the conduct of planned and ad hoc safety reviews and the creation of high quality written communication for internal and regulatory documents as directed by therapeutic area lead physician and PSP management.
Expert understanding and application of the various regulatory modalities (e.g., expedited reports, US periodic reports, PSURs, etc.) used to detect safety signals and their limitations.
Understands and applies the processes associated with safety surveillance activities for assigned therapeutic area(s).
Responsibility for maintaining safety surveillance plans for allocated products up to date and assist in the preparation for the timely presentation of the safety profile for allocated products as specified in applicable safety surveillance plans.
Assists PSP MD for the therapeutic area in signal work-up: a) Characterization of the signal work-up on safety topics for an allocated drug product requested of the PSP department by internal and external (e.g., Regulatory agencies, etc.). b) Defining the strategy that answers the question being asked of PSP, in collaboration with the therapeutic area sub-team. c) Organize the data output to be reviewed and analyzed in a logical way to facilitate data review. d) Review the data output, prepare detailed analyses, and write a draft report summarizing the signal work-up with evidence-based conclusions and recommendations with respect to presence or absence of potential safety signals [examples of such signal work-up end products would include, but not be limited to ad hoc event reviews, PSURs, or responses to domestic or international regulatory agency inquiries] e) ensure timelines are identified and met or communicated and renegotiated if at risk.
Assist the therapeutic area PSP MD by serving as a liaison to the global and clinical project teams to assure the appropriateness of clinical safety monitoring plans and the timely communication of pre- and postmarketing safety signals to the global and local project teams.
Participates in PSP/APUS safety discussions as appropriate. Assists in monitoring the safety surveillance activities for completion of surveillance tracking reports and archiving final versions of surveillance output.
Responsible for the project management of the respective outputs of assigned therapeutic area(s) ensuring on-time delivery of quality documents.
Effectively manages department workload, product responsibilities, and specific training and development to new members in a Therapeutic Area business unit.
Strategic development of training materials for writing processes and directs the training of writing guidelines and standards.
Accountable to the PSP Therapeutic Area Lead physician. Responsible for products in assigned therapeutic area.
Maintains thorough knowledge of product data (literature, labeling, key product issues, current issues in drug class, and company initiatives). Maintains literature archive and disease state resources.
Expert on drug and disease states for therapeutic area. Independently evaluates data, identifies opportunities and risks, weighs alternatives and presents analyses to management for review.
Suggests activities or participates in the development of departmental and/or therapeutic strategies.
Represents functional area on routine issues and facilitates multidisciplinary communications. Reviews the work of others and assists in quality metric acquisition.
Assists with the development of training materials. Mentors lower grade levels and assists in the training of new staff.
Participates in responses submitted to the FDA or international regulatory groups.
Ensures timely decision making, problem solving, follow through and appropriate managerial elevation of issues.
 

 
Position Requirements Minimum of Bachelor’s Degree in Science or Pharmacy or Nursing required.
Minimum of 5 years pharmaceutical experience in a clinical safety/research department required.
Minimum of 5 years of medical writing experience (Prefer experience in writing pharmaceutical reports such as Clinical Study Reports, Safety sections of the ISS and/or EU Common Technical document, PSUR or white paper).
Proven ability to critically evaluate medical data.
Proven understanding of clinical disease state and implications of treatment.
Proven ability to communicate effectively (verbal, presentation at group meetings, etc).
Proven experience with project management (formal or informal).
Prefer experience in training or mentoring.
Strategic thinking, Organizational, Leadership, Results-oriented performance, Team player.
Excellent knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required).
Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
Proven ability to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist.
Excellent written and spoken English
 

 

Please visit www.us.astellas.com to apply.