Travere Therapeutics

Travere Therapeutics

Senior Drug Safety and Pharmacovigilance Specialist

San Diego · Senior

Sponsorship not specified$95k-$124kDetected 32 days ago
GCPExcelClinical TrialsFDA RegulatoryPharmacovigilanceCommunicationCollaborationOrganizational SkillsMicrosoft Office

About the role

  • The Senior Drug Safety and Pharmacovigilance Specialist will be responsible for monitoring the safety of pharmaceutical products, both approved and in development.
  • Assist in the review of individual case safety reports (ICSRs) for accuracy and quality
  • Coordinate with vendors to ensure all internal and external timelines are met, potential issues are communicated, and resolution is achieved in a timely manner.

Responsibilities

  • This position will support the PV team in ensuring flawless execution of PV operations, implementing safety reporting processes, and ensuring compliance with FDA and global safety reporting requirements.
  • Maintain oversight and assist with query management, including review, approval of queries and timely closure of follow-up requests.
  • Develop safety report forms for both clinical trials and postmarket, such as study-specific safety report forms and pregnancy report forms, and postmarket AE report forms
  • Support the development and implementation of PV-related guidelines, work instructions, SOPs, and ensure the uniform and timely processing of adverse event data
  • Support the planning and preparation of aggregate safety reports such as Periodic Safety Reports, periodic line listings, etc., as assigned
  • Support safety signal management activities, including literature search and review
  • Support and participate in inspection readiness activities
  • Maintain understanding and ensure compliance with pharmacovigilance SOPs, Work Instructions (WIs), global regulations (such as FDA and EU Directives), GxPs, and ICH guidelines

Requirements

  • Some travel (10%) may be required, with a potential travel occurring over weekends
  • Self-motivated, well-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
  • Able to work both independently and in a team environment.

Nice to have

  • Patient-Inspired, Courageous, Promote Community, and Stronger Together.

Skills

  • Bachelor's degree in a related Life Sciences discipline (RN, PharmD, PA is preferred).
  • Minimum four (4) years of relevant drug safety and pharmacovigilance experience at a biotech, pharmaceutical, or CRO) company.
  • K nowledge of GVP, GCP, US and EU regulations and guidelines, and other international regulatory requirements.
  • Knowledge of MedDRA dictionary relevant to AE/SAE coding.
  • Proficiency using Safety databases (e.g. Argus, ARISg) and knowledge of Clinical trial databases (e.g. Medidata Rave, etc).
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
  • Creation and maintenance of study-specific Safety Management Plans (SMP) and the study-specific configuration of the safety database
  • Essential Qualifications and Skills:

Compensation

  • Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
  • Target Base Pay Range:
  • $95,000.00 - $124,000.00
  • This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Benefits

  • Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
  • Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Equal opportunity

  • If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com.
  • Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only.
  • Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
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