Global Pharmacovigilance Specialist

Grifols; Los Angeles (CA); On-site; USD 95,000 - 105,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

PTO

Paid holidays

401(k) match

Tuition reimbursement

Bonus pool

Job summary

Grifols, based in California, is seeking a Pharmacovigilance Specialist to provide operational support for global pharmacovigilance activities across marketed products. You will ensure deliverables meet regulatory timelines and manage data review, compilation, and analysis in the integrated safety database.

The role involves AE case processing, regulatory notifications, literature reviews, safety signal evaluation and archiving, plus participation in audits, CAPAs, and SOP development.

Qualifications

• 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

Responsibilities

• 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

Skills

Pharmacovigilance

Data analysis

Communication

Autonomy

Safety databases

Education

Bachelor's in Health sciences

Tools

Safety databases

Job description

Grifols, based in California, is seeking a Pharmacovigilance Specialist to provide operational support for global pharmacovigilance activities across marketed products. You will ensure deliverables meet regulatory timelines and manage data review, compilation, and analysis in the integrated safety database.

The role involves AE case processing, regulatory notifications, literature reviews, safety signal evaluation and archiving, plus participation in audits, CAPAs, and SOP development.