Sr Specialist, Pharmacovigilance, QPPV Office

Location
Gaithersburg, MD
Posted
Oct 09, 2021
Ref
799875400
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time


 

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 Senior Specialist, PV – QPPV Office will participate in the further development of the Qualified Person Pharmacovigilance (QPPV) office and support the oversight of the QPPV partner network.   The position will liaise and collaborate with colleagues from PV, RA, QA, global Emergent affiliates and others as required to help support the maintenance of the PV System Master File (PSMF), negotiation and maintenance of SDEAs and PVAs, and will also participate in global regulatory surveillance as it pertains to pharmacovigilance.
The Senior Specialist, PV – QPPV Office is also responsible for contributing positively, timely, and accurately to the completion of all tasks related to the job position, and following Standard Operating Procedures (SOPs), global Regulatory Health Authority and ICH guidelines, and company policies.

 

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVA):
    • Assist in the preparation, negotiation and maintenance of SDEAs and PVAs ensuring coherence between regulatory requirements, SOPs, and assuring relevant adverse event information is reported to Emergent
    • Support the negotiation process and the establishment of SDEAs and PVAs with relevant partners ensuring that the agreements are in line with regulatory requirements and are achievable for the parties involved.  Includes assisting in the monitoring of key performance indicators such as reporting timelines
    • Works with partners to assist in the reconciliation of ICSRs
  • Pharmacovigilance System Master File (PSMF)
    • Participate in the maintenance of the core PSMF, local PSMF(s) and Annexes on a regular basis to maintain accuracy to the PV process and compliance to regulatory requirements
    • Support and participate the process for collecting and collating data for the PSMF and Annexes
  • Regulatory Surveillance
    • ake part in the regulatory surveillance process, to assist in the assurance of compliance to jurisdictional pharmacovigilance legislation
  • Other PV Activities
    • Assist in the review, update or write company SOPs related to pharmacovigilance and safety reporting to ensure their compliance with EMEA, ICH, and FDA guidelines
    • Contributing to the continuous improvement of job processes and regulatory compliance within the framework of Pharmacovigilance

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    A Bachelors’ Degree Health Sciences or medically related field or relevant experience from a similar position
•    A minimum of two years’ related industry experience.  Experience in Pharmacovigilance, or Regulatory Affairs is highly valued.
•    A good understanding of Good Pharmacovigilance Practices (GVP), Health Canada, FDA, EMA, and ICH safety reporting requirements.
•    Detail oriented, with a focus on quality while maintaining a balanced business perspective.
•    Good working knowledge of medical terminology.
•    Strong communication skills with demonstrated written and verbal communication skills.
•    Strong interpersonal, collaborative and negotiation skills with an ability to build strong and positive relationships.
•    Excellent prioritization and organization skills.
•    Must be able to work independently and as a team in a fast-paced environment 
•    Professional integrity and a proven attention to detail and quality standards is a must.
 

 

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.