SR. SPECIALIST/SPECIALIST REPORTING & SUBMISSION, PHARMACOVIGILANCE

Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs — and into the priorities and concerns of the medical specialists who treat them. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers.

JOB SUMMARY

Under minimal supervision, the Reporting and Submission Specialist is primarily responsible for the reporting and submission of ICSRs to local/regional PV offices, business partners, distributors and health authorities as required to ensure compliance with global requirements. Responsible for supporting maintenance of distribution and reporting rules. Responsible for monitoring report failures and takes immediate corrective actions as required. Maintains processes involved with reporting and submission of ICSRs and serves as the responsible person for maintaining submission records in the safety database. May participate in preparation, analyses and follow-up of adverse event (AE) and serious adverse event (SAE) reports from post marketing or clinical sources. Assures data accuracy, clinically valid case assessment and regulatory reporting status assessment. May assist in reconciliation of safety data from non-interventional studies as required. May serve as a primary point of contact for specific projects in addition to providing Safety support on cross-functional project teams. Participates in creation, update and maintenance of procedural documents in regards to reporting and submission functions. Contributes to the mentoring and training of new colleagues as needed.

KEY DUTIES AND RESPONSIBILITIES: % of Time or Importance
  1. Reporting & Submission
  • Sends out reports daily from Argus for Global Notification and Health Authority Reports via E2B and/ or CIOMs
  • Communicates with SIMR staff to ensure cases are globally notified within specified timelines
  • Monitors for report failures and take corrective actions as required
  • Ensures literature is sent to Health Authorities for those that require manual sending
  • Monitors and sends outbound CIOMS for business partners
  • Supports maintenance of distribution and reporting rules in Argus
  • Submits files to FDA for PADER submission
  • Oversees the recording of ICSR submission records from local regulatory affairs offices and distributors within Argus
  • Monitors SOM testing is completed within documented timelines
  • Runs SAE/AEs listings as required
  • Maintains Global Notification distribution lists
  • Maintains distribution lists for SIMR activities
  • Assists with creating and maintaining procedural documents relating to reporting and submission
/ 60 %
  1. May perform ICSR Processing as follows
  • ICSR processing receipt, collection, processing, follow-up and reporting of safety information cases (aka ICSRs).
  • Receives ICSR information, enters data in adverse event database, selects terms verbatim, makes initial determination of seriousness, expectedness, listedness, and USA FDA reportability.
  • Determines case follow-up activities.
  • Obtains follow-up from consumers and health care providers and works with Medical Safety Physician to finalize serious reports for global notification.
/ 20%
  1. Process, Project Support
  • May participate in special projects and process development activities.
  • Supports the maintenance of Safety database reporting rules
  • May assist in UAT for IS Argus related testing
/ 5%
  1. SOP Development and Training
  • May develop and/or update SOPs (and related documents) and provide staff training as required
  • Participate in mentoring and training of new colleagues
/ 5%
  1. SAE Reconciliation
  • Performs and oversees the activities associated with the safety database reconciliation
/ 10%

Qualifications

Education and Experience

  • Bachelors of Science degree required
  • Minimum of 6 years drug safety experience
  • RN, Nurse Practitioner, Physician Assistant or related healthcare experience preferred
  • Pharmaceutical industry experience preferred; Drug Safety case processing experience highly desirable

OR

  • A Master’s degree
  • Minimum of 4 year drug safety experience
  • Pharmaceutical industry experience preferred; Drug Safety case processing experience highly desirable

OR

  • A PhD
  • Minimum of 2 year drug safety experience
  • Pharmaceutical industry experience preferred; Drug Safety case processing experience highly desirable

Essential Skills and Abilities

  • Good knowledge of medical terminology highly desirable
  • Strong working knowledge of relevant global PV regulations and guidance documents governing both safety reporting and processing for the clinical trial and post-marketing environment
  • Computer proficiency and computer data entry experience required
  • Strong organizational skills, detail oriented, ability to adapt in a fast paced constantly changing environment
  • Clear, effective written and verbal communication skills
  • Ability to work under pressure in order to meet tight deadlines
  • Excellent interpersonal skills (i.e. team player)

EEO/AA M/F/V/D