Reata Pharmaceuticals, Inc. has an opening in Irving, Texas for a Clinical Drug Safety Specialist I, in our growing and dynamic Medical Affairs Department.

Reata Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new drugs that target major unmet clinical needs in kidney disease, inflammation and neurodegenerative diseases. Reata is located in the attractive northwest suburbs of Dallas, TX. 
 

POSITION SUMMARY:

The Clinical Drug Safety Specialist I is accountable for the overall conduct of Drug Safety operations, including preparation and review of safety reports, case assessment, assessment for safety signals, preparation of standard as well as ad hoc adverse event reports, and contribution to regulatory and clinical regulatory documents.

The Clinical Drug Safety Specialist I is responsible for performing their activities in accordance with FDA regulations, ICH/GCP guidelines and applicable SOPs.  He/she functions with supervision, collaborating with inter- and intra-company resources to ensure quality performance and that regulatory and Reata reporting timelines are being met.  

RESPONSIBILIITES:

• Collect, assess, and process safety reports received from any source according to ICH-GCP guidelines, regulatory requirements and Reata's SOPs and procedures.
• Participate in the triaging of safety reports for regulatory reporting purposes.
• Perform quality control review of all assigned cases to ensure accuracy, integrity and completeness of information entered in the safety database.
• Initiate MedDRA and WHO-Drug coding with input from Medical Monitor.
• Follow-up with physicians, other health care professionals and consumers, as appropriate, to obtain additional information on safety cases.
• Prepare and facilitate the submissions of expedited and non-expedited safety reports to regulatory authorities, partner companies and other organizations as needed.
• Establish and maintain auditable safety files in accordance with GCP and ICH standards.
• Provide rotating coverage for SAE handling and other essential department functions during non-business hours, weekends, and holidays according to department defined basis.
• Participate in the planning and preparation of the adverse event section of protocols for Reata's studies and review of CRFs (as necessary).
• Conduct timely review and reconciliation of safety database with clinical database for a given study.
• Oversee and/or implement the generation of queries to the sites for clarification and reconciliation of adverse event reports.
• Support the Clinical Operation teams with respect to safety related issues as required.
• Participate in Clinical Team meetings and similar meetings (e.g., Investigator Meetings) representing Safety Department as required.
• Participate in the development and management of Clinical Event and  Data Monitoring Committees, as applicable, including development of charters (as needed) and ensuring that activities/listings for meetings are completed in a timely manner and meeting outcomes are documented as needed for requests from IRBs/ECs and/or regulatory authorities.
  • Assist with the development and implementation of drug safety Standard Operating Procedures (SOPs).
  • Conduct site and internal safety audits as needed.
  • Ensure timely completion of other safety related tasks as necessary.

CORPORATE COMMITMENTS:

• Demonstrate commitment and support for company goals, objectives and procedures.
• Represent Reata by developing collaborative relationships with site personnel, colleagues and vendors.
  • Demonstrate professionalism and adherence to moral, ethical and quality principles.
  • Participate in corporate and departmental meetings.
  • Comply with applicable regulations, GCP and corporate policies and procedures.

 QUALIFICATIONS:

• Bachelor's degree in Nursing, Pharmacy or Life Sciences required.
• Working knowledge of complex medical disease with a minimum of 2 years of patient management experience; critical care experience preferred OR equivalent relevant clinical research experience.
• 1-2 years of pharmaceutical safety reporting preferred
• Strong GCP and regulatory knowledge including FDA and ICH regulations preferred.
• Strong communication skills both written and verbal.
• Ability to develop and maintain collaborative relationships.
• Ability to assess the inherent risks of a situation, their potential impact on a project and based on this information, independently make timely decisions.
• Working knowledge and experience with Word, PowerPoint and Excel.
• Ability to travel a minimum of 20%.

 
In addition to competitive salaries and a challenging work environment, we offer a comprehensive benefit package including medical, dental, vision, STD/LTD, life and a 401(K) saving program.  We offer a generous Health Savings Account funded by the company. Must be legally authorized to work in the U.S. without sponsorship.  Reata Pharmaceuticals is an Equal Opportunity employer. Apply to recruiting@reatapharma.com with a cover letter and CV.