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
- To develop, review and maintain Quality system aimed at identifying errors
- To review and assess the KPI reports for internal compliance timelines and
- 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
- 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
- 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
- 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
LOOKING FOR TRAINING FOR YOUR TEAM? TELL US ABOUT YOUR REQUIREMENT AND WE’LL GET BACK TO YOU SHORTLY.
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 email@example.com to request a demonstration of all the services.