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. 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 Develop and update company SOPs and department procedural documentation Assist management with ad hoc requests Job Requirements: Bachelor’s 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. 2-3 years of experience with pharmacovigilance and adverse event reporting is highly preferred. Knowledge of EU and US pharmacovigilance practices; existing legislation, regulations and guidelines Expertise in therapeutic products and areas; medical coding; safety-data 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 Equivalency: 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 Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. *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. The estimated pay scale for Pharmacovigilance Specialist role based in California, is $95,000-$105,000 per year. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. #J-18808-Ljbffr
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