Sr Specialist, Pharmacovigilance
Company: Emergent BioSolutions
Location: East Lansing
Posted on: January 27, 2023
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Job Description:
We go where others won't, taking on some of the biggest public
health challenges to protect and enhance millions of lives, and
create a better, more secure world. Here, you will join passionate
professionals who advance their scientific, technical and
professional skills to develop products designed-to protect and
enhance life. The purpose of the Pharmacovigilance Sr Specialist is
to ensure that the processing and submission of adverse event
reports are performed in a compliant manner. The Pharmacovigilance
Senior Specialist is responsible for taking the lead in the
development of departmental procedures and preparation of key
pharmacovigilance documents. Essential Functions --- Collect and
follow up Adverse Event(AE)/Serious Adverse Event (SAE) information
for pre and post marketed products; perform causality assessment of
AE/SAE reports --- Maintain safety information for pre and post
marketed products in a regulatory compliant safety database ---
Provide oversight of safety report submission activities to ensure
compliance with global regulatory/competent authority requirements
--- Participate in the preparation of pre and post marketed product
safety reports, including the Periodic Safety Update Report (PSUR)
--- Review and analyze safety information; perform surveillance of
literature --- Review safety sections of study documents/reports
--- Prepare and present pre and post marketed safety information
for pharmacovigilance monitoring activities/signal detection
meetings, attended by management --- Provide company-wide
pharmacovigilance information throughout the company --- Provide
guidance/training to Pharmacovigilance team members for routine
pharmacovigilance activities and lead various departmental projects
--- Serve as subject matter expert for audits/inspections The above
statements are intended to describe the general nature of work
performed by those in this job. It is not an exhaustive list of all
duties, and other duties may be assigned. Education, Experience &
Skills --- Registered nurse and degree level qualification (e.g.
Bachelor's degree) in medical/scientific field --- 2+ years of
experience with safety database and medical coding dictionaries ---
At least 1 year of experience with setting up safety reporting for
clinical trials --- A minimum of 5-8 years of pharmacovigilance
related experience --- Thorough knowledge of regulations (US and
European) surrounding adverse event reporting for both pre and post
marketed products --- Excellent organization skills; critical
thinking, problem-solving, and decision-making skills Per CDC
guidelines, Emergent strongly recommends that all employees working
on site are vaccinated to help ensure their safety, as well as the
safety of fellow employees. This includes the use of good judgment
when determining when the CDC guidelines advise that you stay home
when ill. There are physical/mental demands and work environment
characteristics that must be met by an individual to successfully
perform the essential functions of the job. This information is
available upon request from the candidate. Reasonable
accommodations may be made to enable individuals with disabilities
to perform all essential functions. Emergent BioSolutions is an
Equal Opportunity/Affirmative Action Employer and values the
diversity of our workforce. Emergent does not discriminate on the
basis of race, color, creed, religion, sex or gender (including
pregnancy, childbirth, and related medical conditions), gender
identity or gender expression (including transgender status),
sexual orientation, age, national origin, ancestry, citizenship
status, marital status, physical or mental disability, military
service or veteran status, genetic information or any other
characteristics protected by applicable federal, state or local
law. Information submitted will be used by Emergent BioSolutions
for activities related to your prospective employment. Emergent
BioSolutions respects your privacy and any use of the information
submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or
candidate submittals from search/recruiting agencies not already on
Emergent BioSolutions' approved agency list. Unsolicited resumes or
candidate information submitted to Emergent BioSolutions by
search/recruiting agencies not already on Emergent BioSolutions'
approved agency list shall become the property of Emergent
BioSolutions and if the candidate is subsequently hired by Emergent
BioSolutions, Emergent BioSolutions shall not owe any fee to the
submitting agency.
Keywords: Emergent BioSolutions, East Lansing , Sr Specialist, Pharmacovigilance, Other , East Lansing, Michigan
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