Pharmacovigilance Corporate Trainings

Excel the recognition of your company

with skilled workforce quality practices

OUR TRAINING SERVICES

To create Quality workforce in Pharmacovigilance

DRUG SAFETY ASSOCIATES

  • To perform quality case processing and evaluation of ICSRs ensuring accuracy
    and consistency with emphasis on timeliness and quality.
  • To ensure accurate and consistent MedDRA and WHO-DD coding
  • To ensure compliance of pharmacovigilance activities

QUALITY REVIEWER

  • To develop, review and maintain Quality system aimed at identifying errors
  • To review and assess the KPI reports for internal compliance timelines and
    performance
  • Coordinates the CAPA reviews and approvals process
  • Updates the audit and capa tracker

DRUG SAFETY PHYSICIAN

  • To manage benefit-risk profile including review and analysis of safety data.
  • To demonstrate strong medical knowledge and analysis for ICSR reports, safety
    documents (e.g. PSURs/PBRERs, signal analysis, RSI, regulatory enquiries, risk
    management plans)
  • To showcase strong knowledge regarding international regulatory requirements.

TRAIN THE TRAINER

  • To demonstrate development, maintenance, and training of Pharmacovigilance team and other related departments in accordance with worldwide Pharmacovigilance
    standards & procedures.
  • To contribute towards preparation of quality standards and guidance documents in coordination with Quality team

COMPLIANCE MANAGEMENT

  • To maintain knowledge of current and developing regulatory guidelines
    internationally for pharmacovigilance system and provide expertise and advice
    to all concerned departments
  • To perform effective communication of issues, recommendations for
    Pharmacovigilance activities at regulatory level

QPPV

  • For effective handling of Marketing Authorization Holder’s (MAH) Pharmacovigilance system effectively and ensuring the system meet the regulatory obligations in regards to safety monitoring of the products
  • To handle all Pharmacovigilance related activities like risk management including detection, assessment, understanding and communication of safety information

OUR TRAINING SERVICES BENEFITS

CUSTOMIZED


As per your requirement

SAVE


Time & Cost

INCREASE


Productivity & Efficiency

LOOKING FOR TRAINING FOR YOUR TEAM? TELL US ABOUT YOUR REQUIREMENT AND WE’LL GET BACK TO YOU SHORTLY.

WHY US?

Customized Pharmacovigilance Training solutions for organizations

ACI has extensive experience in offering quality training and assessment programs for corporate including Pharmaceuticals, Clinical Research organizations, and industries, with the aim of developing skill set within the organization.

Our customized training solutions for organizations facilitate quality and effectiveness in the Pharmacovigilance operational activities by raising the skill standards of the workforce. The training programs are cost effective and customized based on the different levels and skill set and increase overall productivity of the organization.

In order to get a complete overview of what ACI can do for you, please send us an email to info@acitrainings.com to request a demonstration of all the services.

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