7 days old

Sr Specialist, Pharmacovigilance - Remote

Lansing, MI 48933 Work Remotely
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We go where others wont, 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. Bachelors 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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Industry

  • Biotechnology
Posted: 2023-01-25 Expires: 2023-02-27

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Sr Specialist, Pharmacovigilance - Remote

Emergent BioSolutions Inc.
Lansing, MI 48933
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