Grifols Shared Services North America, Inc Pharmacovigilance Specialist in Clayton, North Carolina
Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data review, compilation and analysis including management of the integrated safety database.
Essential Job Duties:
Management of Adverse Events including activities such as processing adverse event case reports and conducts follow-up
Notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies
Reviews scientific literature and bibliographic sources; draft and manage periodic safety update reports.
Evaluates safety profiles; draft and manage signal detection reports; ensures document filing and archiving.
Participation in the processes of involving the collection, processing, review and distribution of adverse event information regarding development and marketed Grifols pharmaceutical products.
Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with concerned departments, affiliates, distributors or business partners
Take part in self-inspection visits, audits, inspections and in CAPAs management, create or update pharmacovigilance procedures and working practices
Provide training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards
Support in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal business practices or working instructions.
Serves in an advisory capacity including activities such as product monographs review; draft responses to pharmacovigilance requests from regulatory agencies; participates in the drafting and implementation of pharmacovigilance contracts and agreements.
Bachelor’s Degree in Health sciences (pharmacy, nursing, medicine, veterinary) or Bioscience (biochemistry, biotechnology, biology) or similar. If bioscience, a master or a second degree is required.
At least one year of relevant experience in pharmacovigilance, clinical research, or regulatory affairs in a CRO or a pharmaceutical company is usually required.
4 years of experience with adverse event reporting is highly preferred.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Knowledge of pharmacovigilance practices; existing legislation, regulations and guidelines;
Expertise in therapeutic products and areas; medical coding; safety-data administration.
he Pharmacovigilance Specialist should possess autonomy and sense of responsibility, analytical and synthesis skills,
Ability to work on multiple projects simultaneously
Excellent communication skills with different internal and external stakeholders.
In addition, other skills and knowledge include scientific expertise and organized work habits as well as good planning skills
Develop and update company SOPs and department procedural documentation.
Assist management with ad hoc requests.
This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position.Other duties may be assigned and qualifications required may change over time.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 146367