Pharmacovigilance Manager

Belcan; Los Angeles (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Belcan in Los Angeles is seeking a Pharmacovigilance Specialist to provide operational support for global pharmacovigilance activities across marketed products. You will ensure deliverables meet regulatory timelines and maintain data quality.

Responsibilities include processing adverse event reports, conducting follow-up, drafting safety reports, supporting signal detection, and assisting with audits and CAPA management.

Qualifications

• Operates global pharmacovigilance activities and ensures regulatory reporting timelines.
• Processes adverse event reports and conducts necessary follow-ups.
• Reviews data in the integrated safety database and supports signal detection.
• Assists with audits, inspections and CAPA management.
• Provides training and maintains documentation per prevailing standards.

Responsibilities

• Manage adverse event case processing including follow-up with partners.
• Notify regulatory agencies as required and respond to inquiries.
• Draft and manage periodic safety update reports.
• Participate in quality audits, CAPA actions and archiving of documents.
• Provide training and maintain training records per the plan.

Skills

Pharmacovigilance

Adverse Event processing

Regulatory reporting

CAPA management

Job description

Job Title : Pharmacovigilance Specialist

Duration : 12+ Months

Summary: Provides operational support for global pharmacovigilance activities of Client 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 Client 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

Belcan is an equal opportunity employerYour application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.