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 followup 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
60 %
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
2. May perform ICSR Processing as follows
20%
 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.
3. 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%
4. 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%
5. 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