Sr. Drug Safety Case Manager (US)

Location: 

Philadelphia Area - Radnor, PA, PA, US

The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients.  In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

 

Headquartered near Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania.  Idorsia is committed to meet the changing needs of healthcare professionals, patients and their families.  The core of what we do is to bring creative solutions to the market based on our science and data.

 

The Senior Drug Safety Case Manager works in a team-oriented environment and is responsible for the processing and reporting of adverse event (AE) reports in compliance with applicable global regulations and Idorsia’s Standard Operating Procedures (SOPs) and guidelines.

 

 

Management of AE case reports:

 

  • Responsible for complete case processing: triaging, data entry, coding of AEs, narrative writing, quality control and submission of expediting AE reports to health authorities.
  • Perform case prioritization according to relevant Standard Operating Procedures to ensure timely submission of expediting reports to regulatory authorities.
  • Identification of missing information and initiation of follow up requests in collaboration with Drug Safety Physician.
  • Daily monitoring of the workflow and work lists to ensure all cases are prioritized and processed as appropriate.
  • Performs or oversees reconciliation activities.

 

Additional responsibilities:

 

  • Contributes to GDS projects and process improvement initiatives as required.
  • Contributes to the development and amendment of assigned GDS operations quality system documents.
  • Provides training to new employees, sales representatives, and External Service Providers (ESP) on collection and management of AE case reports and safety information.
  • Takes a proactive role identifying and communicating opportunities for process improvement, identifies issues and process deviations, conducts root cause analysis, and proposes corrective actions.
  • Provides input and strategic direction to management on any related case processing activities associated with her/his assigned role.
  • Supports improvements on the quality of all adverse event information with emphasis on serious AEs and product specific AEs of special interest that require expedited reporting to Health Authorities.
  • Oversees monitoring of case priorities and timely reportability of adverse event cases to health authorities and license partners (as applicable).
  • Serves as a PV expert providing safety expertise to other functions such as Medical affairs, medical information and others as needed.
  • Contributes to the management of Drug Safety internal audits and inspections.
  • Supports GDS systems initiatives including the identification of new applications, development of user requirements and validation testing activities.
  • Collaborates with DS compliance group in the development of training materials on GDS procedures and pharmacovigilance regulatory requirements.
  • Contributes to the preparation of aggregated periodic reports (e.g. FDA PADER, etc..) and preparation of health authority responses as required.
  • Performs root cause analysis and ensure appropriate management of CAPA and procedural deviations.
  • Ensure compliance to all Idorsia’s SOPs and procedures.

 

Qualifications:

 

  • Bachelor’s degree (or comparable non-US Degree) in Pharmacy, Nursing or related healthcare discipline.
  • Minimum of eight years of overall work experience in an FDA environment with at least five years of experience in drug safety organization processing Individual Case Safety Reports (ICSR) and review of safety data within pharmaceutical industry or contract research organization.
  • Must be willing to travel approximately 10% of the time

 

Competencies:

 

  • General knowledge of medical terminology, MedDRA coding and drug dictionaries.
  • Excellent knowledge of FDA and international adverse event reporting regulations e.g. International Conference of Harmonization (ICH) Guidelines.
  • Experience using drug safety database (preferably Argus).
  • Computer proficiency and data entry experience (Word, Excel, and Power point).
  • Ability to adapt with evolving and fast paced environment.
  • Excellent organizational skills and ability to work under pressure and meet tight timelines.
  • Effective verbal and written communication.
  • Strong interpersonal skills and experience in mentoring.
  • Working with others to identify, define and solve problems.

 

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

 

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

 

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.


Nearest Major Market: Philadelphia