Pharmacovigilance Specialist

STADA is an international pharmaceutical company with a mission to "Care for People's Health as a Trusted Partner" for more than 125 years. The company's business pillars are Consumer Healthcare (CHC) products, generics, and specialty medicines, including biosimilars. STADA products are available in more than 120 countries. In 2022, the region formed by the CIS countries became an independent business unit and was renamed Eurasia with direct reporting to German headquarters. In the region, STADA has fully-fledged companies in most local markets, including Kazakhstan, where STADA Eurasia HQ is located.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:   

Administrative, Health & Safety Management Officer

Pharmacovigilance Specialist   

Almaty  

Job Overview

The Pharmacovigilance Specialist will be responsible for monitoring the safety of pharmaceutical products and ensuring compliance with regulatory requirements. This role involves collecting, analyzing, and evaluating adverse event information to ensure products meet safety standards.

Key Responsibilities

• Adverse Event Reporting:

  • Collect and assess adverse event reports from healthcare professionals, patients, and other sources.
  • Ensure timely submission of individual case safety reports (ICSRs) to regulatory authorities.

• Data Analysis and Evaluation:

  • Analyze safety data to identify potential safety signals or trends.
  • Conduct benefit-risk assessments of products in collaboration with cross-functional teams.

• Regulatory Compliance:

  • Ensure adherence to pharmacovigilance regulations and guidelines, including reporting timelines.
  • Submit periodic safety update reports (PSURs)

• Collaboration and Communication:

  • Work closely with other departments such as Medical, Regulatory Affairs, and Quality Assurance.
  • Provide safety-related information and guidance to internal and external stakeholders.

• Process Improvement:

  • Contribute to the development and updating of Standard Operating Procedures (SOPs) related to pharmacovigilance activities.
  • Participate in audits and inspections and help implement corrective actions.

Qualifications

• Education:

  • Bachelor’s degree in Pharmacy, Life Sciences, or a related field required.

• Experience:

  • Minimum of 2-3 years of experience in pharmacovigilance or a related field.
  • Knowledge of pharmacovigilance regulations in Eurasia and EAEU guidelines (GVP EAEU).

• Skills:

  • Strong analytical and problem-solving skills.
  • Proficient in using pharmacovigilance databases and software.

Key Competencies

• Detail-oriented with a high degree of accuracy.
• Ability to handle multiple projects simultaneously.
• Strong organizational and time management skills.

We look forward to receiving your application via our career portal. At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality.