Sr. Specialist, Safety Quality & Compliance - Remote

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.
JOB SUMMARY
The Patient Safety Quality & Compliance Senior Specialist will support the preparation, delivery, and responses to GVP inspections and audits of the Pharmacovigilance system and assist in the coordination of Patient Safety input to GCP and GMP inspections. The role and position will assist in ensuring inspection readiness, supporting Quality Events and Quality actions (such as deviations, root cause analysis and CAPA plans and effectiveness checks), monitoring quality and compliance with associated Key Performance Indicators (KPIs), and driving continuous improvement across the company pharmacovigilance system.
This role will also provide back up support for the QPPV Office in the maintenance and oversight of the QPPV Partner Network and Business Alliance/Commercial Networks as applied to Patient Safety and Pharmacovigilance.
The Senior Specialist (SQC) will also be an integral part of the Quality Management Systems (QMS) within Pharmacovigilance.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Assist with Pharmacovigilance audit and inspection activities
• Collaborate with Pharmacovigilance team members to complete QMS elements such as deviations, change controls and CAPAs
• Provide support for QPPV office; PV Agreement development and review, maintenance of the QPPV Network and Commercial Networks
• Manage and coordinate Pharmacovigilance department SOP revision process
• Assist with monitoring patient safety relevant regulations and review Regulatory Intelligence and provide updates to team members as required
• Collate KPI information for routine reviews
• Support other department activities as needed
• Assist with the development of departmental process improvements
• Assist with identifying relevant trainings for the team and review training records to ensure compliance with applicable procedures

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
Education: Bachelor’s degree in health sciences or medically related field
Experience: Minimum of 5-8 years of pharmacovigilance experience. Experience with multiple product types (drugs, biologics, devices) preferred. Quality background/training is highly valued.
Knowledge: Solid understanding of Good Pharmacovigilance Practices (GVP), FDA, Health Canada, EMA and ICH regulations. Knowledge of Medical Device Regulations is an asset.
Skills: Intermediate levels of Excel and Word
Abilities:

• Excellent overall communication skills with demonstrated written and verbal communication skills
• Detail oriented with a focus on quality
• Strong project management and organization skills

#LI-Remote
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.
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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.