Pharmacovigilance Specialist (Remote)

Kaztronix; Los Angeles (CA); Remote; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Remote

Zusammenfassung

Kaztronix is seeking a Pharmacovigilance Specialist (Remote) to support global pharmacovigilance activities for marketed products. You will review adverse event reports, manage case processing, and assist in safety signal detection and periodic reporting with focus on regulatory timelines.

The role requires familiarity with international PV guidelines, experience with adverse event data, and ability to collaborate across time zones. Remote work flexibility is offered to support a global team.

Qualifikationen

• Experience in pharmacovigilance and adverse event case processing.
• Knowledge of global regulatory reporting timelines.
• Familiarity with ARGUS or similar PV databases preferred.

Aufgaben

• Manage adverse event case processing, including follow-up with reporters.
• Notify regulatory agencies and partners as required; ensure timely escalation.
• Review literature and draft/update periodic safety reports and signal detection outputs.
• Support CAPAs, audits, inspections, and PV SOPs.
• Provide PV training and maintain training documentation.

Kenntnisse

Pharmacovigilance

Adverse Event Processing

Signal Detection

Data Review & Analysis

Regulatory Compliance

Tools

ARGUS database

Jobbeschreibung

Pharmacovigilance Specialist (Remote)

Summary: Provides operational support for global pharmacovigilance activities of 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.

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 exp 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. This Role is remote