Pharmacovigilance Specialist

• 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

• 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.
• 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 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

Grifols