Sr Specialist, Pharmacovigilance

Company: Emergent BioSolutions
Location: East Lansing
Posted on: January 27, 2023

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