This position involves overseeing drug safety and pharmacovigilance programs to ensure compliance with regulations. Major responsibilities include managing adverse event reporting, reviewing safety reports, designing safety plans for clinical trials, monitoring data safety committees, performing risk assessments, and maintaining safety databases. The ideal candidate has 10-15 years of experience in pharmacovigilance at large pharmaceutical or biotech companies and knowledge of FDA safety requirements and MedDRA terminology.

1. Pharmacovigilance SME
The purpose of this position is to provide drug safety and pharmacovigilance oversight and
guidance on matters concerning clinical programs that may or may not support FDA
licensure/approval of medical countermeasures, to develop and maintain a drug safety and
pharmacovigilance program that complies with regulatory requirements, to evaluate adverse
event and other safety data generated from our client supported clinical and preclinical programs,
to maintain a relevant database, and to proactively monitor medical and scientific literature for
published articles relevant to the safety profiles of products of interest to our client
MAJOR DUTIES AND RESPONSIBILITIES, Design, build, manage, and provide day-to-day
operational oversight and support to drug safety and pharmacovigilance system. Develop and
maintain standard operating procedures related to drug safety and pharmacovigilance. Ensure
compliance with national, regional, and global drug safety and risk management regulations and
codes of conduct.
Review and release final versions of individual case safety reports (ICSRs). Participate in the
writing and review of annual and periodic safety reports. Ensure that all reports are submitted on
time.
Design and draft written safety reporting and safety management plans for clinical
studies. Participate in planning, design, development, and implementation of clinical trial
protocols to ensure consistency and adherence to regulatory requirements and standards. Consult
and collaborate with other scientists on study design, data analysis, and study result
interpretation. Provide sound strategic and scientific input on project objectives and
experimental designs to meet project needs and, when appropriate, FDA licensure/approval
requirements. Collaborate with principal investigators, sponsors, and external representatives to
ensure that project results and conclusions are presented accurately and without bias. Write
and/or review safety sections and conclusions of clinical study reports.
Maintain awareness of current FDA guidelines and requirements for collecting, documenting,
presenting, and reporting clinical trial safety data. Disseminate relevant new regulatory
guidances, publications, articles, summaries, manuscripts, and special reports to other project
team members. Interpret regulatory mandates regarding safety of humans participating in clinical
trials. Ensure appropriate and timely training of relevant employees and service providers
regarding drug safety reporting obligations. Provide direction and guidance to consultants’
clinical publications, abstracts, manuscripts, and grants or contracts as pertains to safety
reporting and analyses.
Serve as the primary person responsible for organizing, coordinating, and supporting data safety
monitoring committees (DSMB) and data monitoring committees (DMCs). Serve as a non-
voting member of the committees when appropriate.
Provide expertise and support for urgent safety reviews for products and compounds of interest,
including issues relating to product quality. Prepare product safety reviews and literature
reviews as required.

2. Manage the safety requirements for product profiles, including adverse event review and
analysis, and maintain oversight of signal detection and risk management activities. Perform
proactive and ongoing risk assessments for products of interest. Assist in the development of
effective risk management strategies and plans.
Participate in the selection and oversight of quality and budgetary aspects of external vendors
providing safety and pharmacovigilance services.
Lead the maintenance of the database of clinical trials, and generate reports for queries
concerning drug safety and adverse event reporting. Enter data, review, and correct databases,
and create new data files. Assist in the development and modification of software programs to
extract, tabulate, and compile safety data.
Base Salary - $180,000 to $220,000
Benefits - Full
Relocation Assistance Available - Possible for ideal candidate
Interview Travel Reimbursed - Yes
10+ to 15 years experience
Minimum Education - Professional Degree
Willingness to Travel - Occasionally
Skills and Certifications
PhD
FDA Safety and Pharmacovigilance
pharmaceuticals
MedDRA
Ideal Candidate, Pharmacovigilance Subject matter expert with strong knowledge of FDA
safty rules. The ideal candidate will have 10+ years in Pharmaceutical and Biotech industry
knowledge. MedDRA knowledge is expected.
Ideal Candidate should have worked for the following company(ies): Large Pharmaceuticals and
Biotechnology