Job Description

Our pharmaceutical client in Los Angeles, CA is seeking a Pharmacovigilance Specialist to join their team on a 1 year contract.

Location: Los Angeles, CA or Remote

Job Type: Contract, on our W2 - No third parties

Visa: Must be authorized to work in the US without sponsorship.

This position is for Adverse event monitoring. This person will deal with marketed products and side effects, follow up with reporters (patients, Doctors, etc.), and triage case reports. Looking for someone with a background in Pharmacovigilance who can follow international regulatory guidelines. Preference is for the ARGUS database. PSUR experience would be nice.

The interview will consist of a phone screen with the local manager and a second phone screen with management in Barcelona. The team is based in LA, but it is a global team and will need someone who can be flexible in scheduling meetings across multiple time zones. The preference is for someone in LA for a hybrid setup, but the team could be open to remote workers.

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.

Primary responsibilities for the role:

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 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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

• Dice Id: 10111638
• Position Id: 8485307

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