Pharmacovigilance Officer

Demo S.A.
Indiana, United States
Posted
On-site
Full-time
Entry-level
1+ YoE
Job Description

In this dynamic and fast growing environment, we are looking for a high caliber Pharmacovigilance Officer who will be responsible for performing pharmacovigilance activities across a diverse portfolio of medicinal products

 

Main duties and responsibilities: 

  • Perform global literature screening and review in accordance with GVP requirements.
  • Review, assess, process, and accurately record Individual Case Safety Reports (ICSRs) in the company’s pharmacovigilance database.
  • Conduct routine review and management of ICSRs received from the MHRA and EMA through EudraVigilance.
  • Maintain and update the EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD).
  • Ensure the timely and compliant handling of safety information in line with applicable pharmacovigilance regulations and company procedures.
  • Maintain accurate documentation and support pharmacovigilance activities to ensure ongoing regulatory compliance.

Requirements

  • Bachelor’s degree in Pharmacy, Life Sciences, Biology, or a related discipline from a recognized institution, relevant Master’s degree will be considered an advantage.
  • At least one year of hands-on pharmacovigilance experience within the pharmaceutical industry or a global PV services organisation.
  • Professional fluency in English, with confidence working in an international environment.
  • Strong digital literacy, including proficiency in Microsoft Office; experience with pharmacovigilance databases is an advantage.
  • Excellent communication and cross-cultural collaboration skills.

Benefits

The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.

Benefits
401(k) or Equivalent
Health Insurance
Dental Insurance
Vision Insurance
Paid Vacation Days
Paid Holidays
Paid Parental Leave
Tuition Reimbursement
Tools & Technologies
Microsoft Office