Pharmacovigilance Specialist 519646
Pharmacovigilance Specialist 519646
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$ 90000 - 100000
1 Vacancy
Job Description
Would you like to join an international team working to improve the future of healthcare Do you want to enhance the lives of millions of people Grifols is a global healthcare company that since 1909 has been working to improve the health and wellbeing of people around the world. We are leaders in plasmaderived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions.
Job Summary:
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 followup
- 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 selfinspection 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
- Develop and update company SOPs and department procedural documentation
- Assist management with ad hoc requests
Job Requirements:
- Bachelors Degree in Health sciences (pharmacy nursing medicine veterinary) or Bioscience (biochemistry biotechnology biology).An advanced degree is preferred (M.S. Pharm.D.
- At least one year of relevant experience in pharmacovigilance clinical research or regulatory affairs in a CRO or a pharmaceutical company is usually required.
- 23 years of experience with pharmacovigilance and 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 Bachelors degree plus 4 years of experience an equivalency could include 8 years of experience an Associates degree with 6 years of experience or a Masters degree with 2 years of experience
- Knowledge of EU and US pharmacovigilance practices; existing legislation regulations and guidelines
- Expertise in therapeutic products and areas; medical coding; safetydata administration
- Pharmacovigilance Specialist should possess autonomy and sense of responsibility analytical prioritization and synthesis skills
- System knowledge of safety databases is required
- 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
Pay scale of $90000 $100000/year. This position is eligible to participate in up to 5 of the company bonus pool. We offer benefits including medical PTO up to 5 401K match and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries Grifols prides itself on its familylike culture. Our company has more than tripled its workforce in the last 10 years were growing and you can grow with us!
*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic or status protected by law. 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.
Location:NORTH AMERICA : USA : CALos Angeles:USVALLEY Valley Bl Mfg Plant LA CA
Required Experience:
Unclear Seniority
Employment Type
Full-Time
