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Pharmacovigilance (PVG) Associate

Houston, TX | Other
4 Days Ago

Job Description

Why Pharm-Olam

Pharm-Olam, LLC & CATO-SMS have merged to form Allucent!

 

We are a mid-size, full-service Contract Research Organization (CRO) and development organization with a massive global reach. Our international resources are dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. We have 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 are a non-laboratory environment with a unique working environment offering a global team culture as well as a competitive salary & benefits package.

This is Important Work

The Pharmacovigilance Associate (PVA II) coordinates, administers, maintains the logistical aspects of pharmacovigilance activities in clinical trials and post-marketed programs to ensure an effective and accurate collection, database entry, review and reporting of safety data of CATO SMS Pharmacovigilance. The PVA II is a member of the Pharmacovigilance staff.

 

This is a full-time, direct hire opportunity for an experienced PVG Associate residing near our Houston, TX or Cary/RTP, NC office. Ideal candidates should have experience writing safety narratives (clinical and/or post marketing). ARISg & CRO experience is required for this role.

Your Role

Recording

  • Create/maintain study-specific forms for collection of safety data (SAE forms, etc.)
  • Document potential serious adverse event (SAE) information during intake of calls/email/fax
  • Collect SAE forms from sites in cooperation with CRA(s)
  • Review SAE forms received and determine if a follow-up query is required
  • Performance of initial safety review and triage of SAEs to determine seriousness, expectedness, and priority, including the timeline for response
  • Write effective narratives for studies/expedited reports as needed.
  • Able to perform query generation applicable to report
  • Review and perform quality check of safety narratives summarizing all relevant medical information for individual case safety reports
  • Review and quality check of process safety documents (Expedited Reports (CIOMs Forms), Annual Safety Reports (ASRs), etc.)

Safety data management

  • Contribute to the performance of coding review of data from clinical study databases using standardized medical dictionaries (such as MedDRA)
  • Liaise with the data management department to obtain required safety data and to provide safety input when required
  • Support reconciliation of clinical and safety databases

Reporting

  • Collect and perform quality control of safety documents to be reported to regulatory authorities, ethical committees and sites
  • Submit safety documents to regulatory authorities and ethics committees according to regulatory requirements including the generation of safety letters in collaboration with Sr. PVA or PVM
  • Create/maintain study tracking logs for regulatory submissions

Other responsibilities as required.

Required Education and Qualifications

  • Degree in life science, healthcare and/or related fields is preferred
  • Minimum 3 -5 years of experience in clinical and post-marketing PV
  • Good knowledge of GDP, GCP, GVP, GDPR and HIPAA regulations
  • Experience working in ArisG safety database required
  • Fluency in medical terminology
  • Understanding of medical records including laboratory results and procedures
  • Experience with MedDRA and WHODrug coding

Skills:

  • Strong written and verbal communication skills including fluency in English language
  • Excellent interpersonal skills
  • Ability to work in a fast-paced challenging environment of a growing company
  • Highly organized, efficient and detail-oriented
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required
  • Excellent analytical and problem solving skills

Apply Now

 

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

 

Pharm-Olam/CATO-SMS 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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