Pharmacovigilance Specialist

Grifols•Los Angeles, CA

11d•Onsite

About The Position

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.

Requirements

Bachelor’s Degree in Health sciences (pharmacy, nursing, medicine, veterinary) or Bioscience (biochemistry, biotechnology, biology).
At least one year of relevant experience in pharmacovigilance, clinical research, or regulatory affairs in a CRO or a pharmaceutical company is usually required.
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
Scientific expertise and organized work habits as well as good planning skills

Nice To Haves

An advanced degree is preferred (M.S., Pharm.D.)
2-3 years of experience with pharmacovigilance and adverse event reporting is highly preferred.

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