MANAGER, 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
The Pharmacovigilance Manager Oversees the processing and reporting of safety information
cases (aka ICSRs). He/she is responsible for 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 serve
as a primary point of contact for specific projects in addition to providing Safety support on crossfunctional project teams. Responsible for the reconciliation of the safety database. Ensures and
contributes to the mentoring and training of new colleagues . Hire, train and manage staff
including mentoring, performance management, workload prioritization and
coaching/development.
KEY DUTIES AND RESPONSIBILITIES:
% of Time or
Importance
1.
ICSR Processing
 Oversees and ensures timely case processing and reporting
activities of Individual Case Safety Reports (ICSRs) for
assigned products from all sources
 Performs ICSR processing and reporting of safety
information cases (including data entry of safety
information, initial determination of seriousness,
expectedness, listedness, and USA FDA reportability.
Determining follow-up activities.
 Obtains follow-up from consumers and health care providers
or investigator sites as required.
 Collaborates with Medical Safety Physician as needed and
ensures medical review is complete
 Ensures timely global notification of reports as required.
50 %
2.
SAE Reconciliation
 Oversees and may perform the activities associated with
the safety database reconciliation for Allergan Clinical Trials
10%
3.
Process Project and System Support
 May participates in or assists in leading special projects and
process development or improvement activities.
May provide support for business owner of global safety
database and related systems (i.e. testing and validation,
identification of database enhancements, change control
activities
10%
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
15%
5.
People management
 Hire, train and manage staff including mentoring,
performance management, workload prioritization and
coaching/development.
 Actively promote staff empowerment and accountability.
15%
Qualifications
Education and Experience
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Bachelor’s of Science degree required
Minimum of 9 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
1-2 years leadership experience preferred
OR
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A Master’s degree
Minimum of 7 year drug safety experience
Pharmaceutical industry experience preferred; Drug Safety case processing experience highly
desirable
1-2 years leadership experience preferred
OR
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A PhD
Minimum of 5 year drug safety experience
Pharmaceutical industry experience preferred; Drug Safety case processing experience highly
desirable
1-2 years leadership experience preferred
Essential Skills and Abilities
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Good knowledge of medical terminology highly desirable
Working knowledge of relevant regulations and guidance documents governing both safety
reporting and processing for 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
Good interpersonal skills (i.e. team player)
EEO/AA M/F/V/D