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Sr. Specialist, Pharmacovigilance

Location: 

Gaithersburg, MD, US, 20879


Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Specialist, Pharmacovigilance (PV) - TAT will be an integral part of the Therapeutic Area Team (TAT) in providing daily oversight of all pharmacovigilance activities for assigned marketed and investigational products.  The role will also represent Global PV on numerous cross-functional teams for issues related to assigned products.

 

ESSENTIAL FUNCTIONS:    
•    Monitors the benefit-risk profile of assigned products
•    Assists in providing medical oversight of assigned pharmacovigilance activities for all phases of clinical trials and post-marketed products within TAT
•    Review and analyze safety information, including literature surveillance
•    Review of Adverse Event (AE)/Serious Adverse Event (SAE) information within Emergent’s global safety database, including MedDRA/WHO Drug coding, causality assessment, and QC
•    Provide oversight of safety report submissions to ensure compliance with global Health/Competent authority and partner requirements
•    Prepare and present safety information for signaling meetings
•    Contribute to the preparation of Aggregate Reports (e.g. PADERs, PSURs, PBRERs, DSURs, RMPs)
•    Review and occasionally author safety sections of documents (e.g. study documents/reports, Health/Competent Authority requests, submission packages, product labeling, Investigational Brochures)
•    Responsible for maintenance of Company Core Safety Information (CCSI)
•    Assists with medical assessments for various issues (e.g. manufacturing out-of-specifications)
•    Function within a company matrix with several key groups (e.g. Medical Affairs, Clinical, Quality Assurance, and Regulatory Affairs on PV-related issues/projects
•    Serves as resource for inspections and audits

 

EDUCATION, EXPERIENCE, SKILLS
Education
•    Bachelor’s Degree in a scientific, life sciences, or medical field; advanced degree (certification/licensure) in Nursing or Pharmacology preferred
Experience
•    2 – 3 years’ experience working within Pharmacovigilance
•    2 – 3 years’ experience working in the medical field (clinical or as a technician)
•    Experience with vaccines, opioid misuse, or medical devices preferred
•    Experience with safety database; preferably Argus Safety
Skills
•    Working knowledge of Good Pharmacovigilance Practices – European Regulations and Directives, CIOMS
•    Working knowledge of Working Group, Code of Federal Regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
•    Excellent ability to analyze and effectively communicate product safety information
•    Demonstrates an attention to detail, results oriented, and good organizational skills
•    Self-motivated with the ability to work both independently and collaboratively within a team environment
•    Ability to adapt quickly to a changing business environment

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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 actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

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


Nearest Major Market: Washington DC