Pharm-Olam, LLC

Drug Safety Officer

Job Locations US-TX-Houston | US-NC-Raleigh-Durham
Job ID
2021-2921
Category
Medical Affairs & Pharmacovigilance

Overview

About Pharm-Olam, LLC:

 

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

Summary:

 

Works with an international team of medical monitors and drug safety officers to ensure that the medical/clinical integrity and quality of studies conducted by Pharm-Olam, LLC are conducted in compliance with all Regulatory Bodies and International Good Clinical Practices (GCP). Functions as the main point of contact at the Pharmacovigilance (PVG) Unit for the receipt, and uniform and timely processing of Serious Adverse Events (SAEs). Responsible for collecting, monitoring, processing, and MedDRA coding event terms of SAEs and distributing Serious Adverse Event reports (SAER) and information queries for investigational and marketed products based on regulatory requirements.

Responsibilities

Database Management

  • Verifies database set-up of study-related data: protocol, sponsor, product, indication, and other designated information
  • Enters all SAE information into safety database
  • Obtains study-specific number for database entry
  • Imports all SAE documentation into safety database
  • Applies database validated MedDRA coding
  • Executes queries within the safety database
  • Retrieves database verification of similar adverse events
  • Maintains current database training requirements
  • Generates regulatory reports, including CIOMS I/MedWatch forms and/or line listings as needed for safety report preparations to the competent authority
  • Generates reports as necessary: CIOMS line listing; AER; and Brief AER

Regulatory Reporting

  • Triages all SAEs for expedited reporting
  • Applies knowledge of international regulatory requirements for safety reporting
  • Prepares and reviews MedWatch/CIOMS I forms and obtains approval of the forms from Medical Monitor and/or Sponsor before regulatory submission
  • Compiles final documents for paper based SAE reporting  to regulatory authorities/competent authorities and submits to the regional Regulatory Specialist
  • Tracks SUSAR submissions, line listings, and AERs as required

Miscellaneous Duties

  • Assists the Medical Monitor in the preparation and distribution of DSMB charters and keeps track of all amendments
  • Assists the Medical Monitors in other safety related duties as required
  • Prepares the study-specific safety plans for Medical Monitor review and approval
  • Develops, coordinates, and completes clinical study safety training for all relevant team members as specified in study allocation

Level of Responsibility:

  • Initially supervised to work as DSO on any studies, normally acting as back up to lead DSO
  • Performs preliminary processing of PVG-Clinical Safety data including serious adverse events (SAEs) and post-marketing adverse events (AEs)
  • May assist in performing QC audit of safety databases
  • Available for general assistance to Business Development

Working relationships:

  • Reports to PVG PM/Drug Safety Officer
  • Works with Medical Monitors, Clinical Research Associates, Project Managers, and ADPMs to support cooperative exchange of study and safety data.

Qualifications

  • In possession of a high school certificate with some medical/nursing or related background or education.
  • Preferably in possession of Natural Sciences, Medicine, Pharmacology or Biochemistry Bachelor level degree or studying towards it or a Nursing background
  • High level of Organizational and IT skills.

 

For Consideration

 

Please apply online at www.pharm-olam.com/careers

 

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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