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 PV Specialist - GVO will be integral in the day-to-day operations of the Global Pharmacovigilance department with a primary focus on processing and submission of adverse events in accordance with internal and external regulatory standards and timelines. As a part of case processing, the role will be involved in workflow management, ensuring data integrity/quality, working collaboratively with internal and external parties/team members. The position is also responsible for the preparation of routine pharmacovigilance documents. In addition, the PV Specialist will be involved in vendor oversight and compliance.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. perform the essential functions
- Ensure safety information is triaged, processed, reviewed, and submitted per global regulatory and business partner agreement requirements
- Ensure accuracy and timeliness of submissions (primarily E2b) to Regulatory Authorities and Business Partners
- Support Marketing Authorization Holder updates to Regulatory Agencies (e.g. ART 57 updates, Gateway registrations)
- Provide communication and updates to Regulatory Agencies related to ICSR submissions EMA, Health Canada, US FDA, etc.)
- Liaise with Therapeutic Area teams to ensure local and product specific requirements are incorporated into pharmacovigilance activities (e.g. submissions, notifications, labelling assessments, etc.)
- Serves as a resource for inspections and audits • Maintain well organized, auditable regulatory files
- Assist with activities related to the review of scientific literature • Provide oversite for day-to-day operations with business partners/third-party vendors
- Represent Global PV in clinical study related activities including receipt, triage, notifications, and query management of clinical study safety information
- Participate in activities related to the maintenance of the Pharmacovigilance System Master Files Page 2 of 3
- Provide back-up and overflow support for other members of GVO, as needed
- Function within a company matrix with several key groups including Medical Affairs, Clinical Operations, Quality Assurance, and Regulatory Affairs 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
- Bachelor’s degree in a scientific, life sciences, or medical field; nursing or pharmacology preferred
- 2-4 years’ experience working within a Pharmacovigilance; experience working in the medical field (clinical or as a technician) may be considered
- Experience with safety database operations; preferably Argus Safety
- with Regulatory Authority Submissions preferred
- Working knowledge of Good Pharmacovigilance Practices – European Regulations and Directives, CIOMS
- Working knowledge of Working Group, Code of Federal Regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- Intermediate level of Excel is a plus
- Demonstrates an attention 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
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.
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.