Recent Searches

You haven't searched anything yet.

1 Pharmacovigilance (PVG) Associate Job in Houston, TX

SET JOB ALERT
Details...
Pharm-Olam International
Houston, TX | Other
6 Months Ago
Pharmacovigilance (PVG) Associate
Other | Business Services 6 Months Ago
Save

sadSorry! This job is no longer available. Please explore similar jobs listed on the left.

Pharm-Olam International is Hiring a Pharmacovigilance (PVG) Associate Near Houston, TX

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.

To connect with our community, follow Pharm-Olam on LinkedIn.

Job Summary

JOB TYPE

Other

INDUSTRY

Business Services

POST DATE

09/21/2022

EXPIRATION DATE

12/12/2022

HEADQUARTERS

BRACKNELL

SIZE

50 - 100

FOUNDED

1996

CEO

NATALIE KAY GASSEN

REVENUE

$10M - $50M

INDUSTRY

Business Services

Show more

The job skills required for Pharmacovigilance (PVG) Associate include Collaboration, Promotion, etc. Having related job skills and expertise will give you an advantage when applying to be a Pharmacovigilance (PVG) Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Pharmacovigilance (PVG) Associate. Select any job title you are interested in and start to search job requirements.

For the skill of  Collaboration
UGS_USA Ubiquity Global Services_U.S.
Remote | Full Time
$25k-31k (estimate)
Just Posted
For the skill of  Promotion
Optimal Wireless
Full Time
$49k-78k (estimate)
Just Posted
Show more

The following is the career advancement route for Pharmacovigilance (PVG) Associate positions, which can be used as a reference in future career path planning. As a Pharmacovigilance (PVG) Associate, it can be promoted into senior positions as a Pharmacy Technician Supervisor that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Pharmacovigilance (PVG) Associate. You can explore the career advancement for a Pharmacovigilance (PVG) Associate below and select your interested title to get hiring information.