Safety Data and Reconciliation Specialists
Title: Safety Reconciliation Specialist
Duration: 12 Months
Location: Morristown, NJ 07962
Job Description:
The incumbent is responsible for litigation intake, including receipt of cases via email and gateway interface with from legal vendors, and related reconciliation and tracking. The incumbent is also back up to the
US PV Safety Data and Reconciliation Manager, to ensure responsible for the
receipt, prioritization, completion and archive of reconciliations with vendor partners for PSDMPs, CRSs, and AOL programs, and internal organizations in support of compliance, and as required by Pharmacovigilance Agreements with vendor partners in accordance with Company SOPs (Standard Operating Procedures) and regulatory guidelines.
The reconciliation of potential safety reports with vendor partners, and data management activities in support of litigation case handling for all incoming U.S. adverse event reports is critical for the company to maintain compliance with local and international regulations. Additional responsibilities include data management activities associated with incoming legal cases and associated medical records and US PV Triage daily workload metrics tracking activities.
Position duties & responsibilities:
• The Safety Data and Reconciliation Specialist ensures that all adverse event reports are reconciled by the local US PV organization in accordance with Pharmacovigilance Agreements and determines when additional efforts and escalation are required to ensure receipt of adverse event reports from partner vendors. Additionally, the SDRS ensures reconciliation with legal vendors for all legal medical records. This role is critical to FDA and global Health Authority compliance.
• Analyze incoming communications from vendor partners for PSDMPs,
• CRSs, and AOL programs in support of compliance, in accordance with Company SOPs (Standard Operating Procedures) and regulatory guidelines, and use critical thinking to prioritize workload of reconciliations.
• Communicate with identified external partners and programs, as well as internal functions to facilitate reconciliation processes and ensure compliance to regulatory reporting timelines regarding adverse event report forms, escalating issues as needed to management in a timely manner.
• Perform daily, weekly, and monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required. Use critical thinking skills to locate and recognize adverse event reports both within the Safety Database and Document Repository, from varied and diverse formats of reconciliation listings.
• Perform archiving and tracking of reconciliations in accordance with applicable processes and procedures, using critical judgment to observe and detect any issues, and make the determination of what may result in a delay with regards to regulatory reporting timelines, notifying management as needed.
• Reconcile daily incoming volumes into Argus Intake Worklist by internal functions (Consumer Relations) and external vendor partners utilizing gateway interface to Argus Intake Worklist
• Make determination of when communication with US PV Intake Group and management is necessary to expedite potential safety cases coming in as a result of reconciliation activities.
• Analyze incoming bulk Medical Records from external Legal Vendors and other sources, in order to prepare for upload into the Document Repository and Workflow Processing system. Independently identifying any and all issues regarding Medical Records, and communicating with external Legal Vendors promptly to address them, escalating to management when necessary.
• Upload bulk Medical Records, and in consultation with Assistant
• Director, USPV MRT, triage and assign Medical Records to the appropriate users or groups for extraction.
• Monitor USPV MRT Mailbox and upload incoming Legal Complaints, or other potential legal cases into the Document Repository and Workflow Processing system.
• Identify and follow department procedures for AEs associated with product complaints.
• Track litigation metrics
Qualifications
Requirements/Preferences
Education Requirement(s):
· Requires a Bachelors of Arts or Bachelors of Science, Registered Nurse, or Pharmacist with at least 3 years of drug safety experience
Skill & Competency Requirements:
• Experience in triaging of source documents and reconciliation preferred.
• Global drug safety database knowledge is preferred along with knowledge of regulatory roles and proficiency with regulations, locally as well as globally.
• Familiarity with ARGUS Safety Database, including experience performing duplicate checks and filtering Argus reports to identify cases, is preferred.
• Must be a team player; possess excellent communication skills with a high degree of overall poise, tact and courtesy; must be detail oriented and be willing to work in a hectic paced environment with time¬ sensitive materials.
Additional Information
All your information will be kept confidential according to EEO guidelines.