Resume and Skills for Pharmacovigilance Analyst

Pharmacovigilance Analyst is one of the most significant roles in the Healthcare sector responsible for various PV activities including adverse event reporting activities including data entry, quality control (QC), follow-up, medical review, and documentation. 

Skills required for a Pharmacovigilance Analyst role

  • Quality Compliance
  • Case Identification
  • MedDRA coding
  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice(GVP)
  • Information Management
  • Clinical & Regulatory Writing
  • MS Office Suite 
  • Problem Solving
  • Scientific writing
  • Reporting Analyst
  • Risk assessment
  • Healthcare
  • Observational Skills

What recruiters look for in a Pharmacovigilance Analyst resume: 

  • Adept with the pharmacovigilance industry-related processes.
  • Prior experience in management within the pharma industry.
  • Strong research skills including observation, analysis, assessment, and reporting. 
  • Solid understanding of ethical pharma practices and international quality standards.

What can make your Pharmacovigilance Analyst resume stand out:

A strong summary that demonstrates your skills, experience, and background in pharmacovigilance

  • Driven and resourceful pharmacovigilance professional experienced in the complete range of industry-related processes including ICSR data input, medical safety document analysis and composition, formulation and execution of standard operating procedures, and corrective action plans.

Targeted job description 

  • Manage safety cases, including case intake/triage, data entry, quality assessment, medical review, and follow-up activities following the global regulatory requirements.
  • Assist with projects in a dedicated safety database environment with pharmacovigilance (PV) systems projects.
  • Support the team on safety-related issues and submit clinical regulatory responses to the health authorities as required

Related academic background 

  • Drug Development Product Management Specialization from UC San Diego, Coursera
  • Certificate in Pharmaceutical Quality Assurance from JSS Medical College
  • M.Pharm (Pharmacology) from Pune University, Pune | 2016 - 2019
  • B. Pharm from Savitribai Phule Pune University, Pune | 2013 - 2016

Sample Resume of Pharmacovigilance Analyst in Text Format

Ishan Jain

Pharmacovigilance Analyst

9470641210 | ishjain@gmail.com |Rohini, New Delhi

SUMMARY

Driven and resourceful pharmacovigilance professional experienced in the complete range of industry-related processes including ICSR data input, medical safety document analysis and composition, formulation and execution of standard operating procedures, and corrective action plans.

EMPLOYMENT HISTORY

Analyst-Pharmacovigilance at Accenture, New Delhi \ Mar 2021 - Present

  • Manage safety cases, including case intake/triage, data entry, quality assessment, medical review, and follow-up activities following the global regulatory requirements.
  • Assist with projects in a dedicated safety database environment with pharmacovigilance (PV) systems projects.
  • Support the team on safety-related issues and submit clinical regulatory responses to the health authorities as required.

Drug Safety Associate at Jubilant-Biosys, New Delhi | 2019 - 2021

  • Processed more than 6000 ICSR and disposition of more than 2000 ICSR from IRT to ARISg, including spontaneous, patient support programs, Market Research Programs, and Non-Interventional studies.
  • Handled Quality reviewer’s position and performed a quality check of ICSR, processed by case processor for accuracy and completeness.
  • Served as a Subject Matter Expert during regulatory inspections, business partner audits, and quality investigations

PROJECTS

  • M. Pharmacy project entitled “Pharmacological Evaluation of a Mushroom for its Anti-inflammatory and Anti-Arthritic Activity in rat models.”

PROFESSIONAL ENHANCEMENTS

  • Drug Development Product Management Specialization from UC San Diego, Coursera
  • Certificate in Pharmaceutical Quality Assurance from JSS Medical College

EDUCATION

M.Pharm (Pharmacology) from Pune University, Pune | 2016 - 2019

B. Pharm from Savitribai Phule Pune University, Pune | 2013 - 2016

Higher Secondary from Delhi Public School, Rohini, Delhi | 2013

SKILLS (TECHNOLOGY/FUNCTIONAL)

Social Media Marketing | Donor Relations | Social Network | Social Networking | Communication | MS Office Suite | Problem Solving

LANGUAGES

English 

Hindi