Rahul Madan

FAQ About Rahul Madan

• What is Rahul Madan's address?

  Rahul Madan is located at
  Ireland

• What is Rahul Madan's job title?

  Rahul Madan is a
  I have around 10 years’ experience in the Pharmaceutical Industry working in different areas of Pharmacovigilance. I am currently working as Safety Aggregate Reporting Manager at IQVIA (Ireland). My key responsibilities include writing aggregate reports [Development Safety Update Reports (DSURs), Periodic Safety Update reports(PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Medical Device aggregate reports-IDE reports, Addendum to clinical overviews (ACOs)], writing Risk Management Plans (RMPs), reviewing Labeling deliverables, Health Authority Query responses, Signal Management, Benefit-Risk Management activities including authoring BRM sections, Benefit Risk Assessment reports, Risk Minimization Material development, Implementation and tracking. Previously, I was working with Bayer, Ireland as a PV Country Head Deputy. I supported the PVCH in managing all the PV based activities in Ireland according to the Irish and EU legislation. This included, but not limited to adverse event and device event handling, local safety issue and crisis management, risk management planning, safety reports review and submissions, local support to Product Technical Complaints and counterfeit processes, drafting PV agreements/Safety Data Exchange Agreements (SDEAs). Before working at Bayer, I was working with PAREXEL, writing and coordinating various kinds of aggregate reports. I also have worked in ICSR reporting, narrative writing and signal detection teams. In order to further achieve my professional goals and to enhance my skills on various facets of PV, I pursued Professional Certification in Pharmacoepidemiology and Pharmacovigilance from London School of Hygiene and Tropical Medicine, London, UK. During the course, I was trained by experienced professionals from EMA, MHRA and the industry on various aspects of drug safety and risk-benefit of drug use. I got a chance to expand my knowledge base around the following topics: •International drug safety regulations (ICH, GVP Modules, CIOMS, FDA, MedDRA guidelines) •Signal detection and assessment •Statistical methods for signal detection (PRR, ROR, EBGM, BCPNN/IC methods) •Signal Prioritization (Impact analysis of safety signals) •Risk Management Planning and Pharmacoepidemiology• Vaccine PV •Pharmacoepidemiology •Application of Pharmacoepidemiology in PV •Clinical Trial designs- Experimental and Observational study designs (Randomized Clinical trials, Descriptive studies, Cross-sectional studies, Cohort studies, Case-Control studies and Case Only designs)•Critical Appraisal of Clinical trials Iqvia

• What industry does Rahul Madan currently work in?

  Rahul Madan currently works in the
  Iqvia

• What is Rahul Madan's area of expertise?

  Rahul Madan specializes in
  I have around 10 years’ experience in the Pharmaceutical Industry working in different areas of Pharmacovigilance. I am currently working as Safety Aggregate Reporting Manager at IQVIA (Ireland). My key responsibilities include writing aggregate reports [Development Safety Update Reports (DSURs), Periodic Safety Update reports(PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Medical Device aggregate reports-IDE reports, Addendum to clinical overviews (ACOs)], writing Risk Management Plans (RMPs), reviewing Labeling deliverables, Health Authority Query responses, Signal Management, Benefit-Risk Management activities including authoring BRM sections, Benefit Risk Assessment reports, Risk Minimization Material development, Implementation and tracking. Previously, I was working with Bayer, Ireland as a PV Country Head Deputy. I supported the PVCH in managing all the PV based activities in Ireland according to the Irish and EU legislation. This included, but not limited to adverse event and device event handling, local safety issue and crisis management, risk management planning, safety reports review and submissions, local support to Product Technical Complaints and counterfeit processes, drafting PV agreements/Safety Data Exchange Agreements (SDEAs). Before working at Bayer, I was working with PAREXEL, writing and coordinating various kinds of aggregate reports. I also have worked in ICSR reporting, narrative writing and signal detection teams. In order to further achieve my professional goals and to enhance my skills on various facets of PV, I pursued Professional Certification in Pharmacoepidemiology and Pharmacovigilance from London School of Hygiene and Tropical Medicine, London, UK. During the course, I was trained by experienced professionals from EMA, MHRA and the industry on various aspects of drug safety and risk-benefit of drug use. I got a chance to expand my knowledge base around the following topics: •International drug safety regulations (ICH, GVP Modules, CIOMS, FDA, MedDRA guidelines) •Signal detection and assessment •Statistical methods for signal detection (PRR, ROR, EBGM, BCPNN/IC methods) •Signal Prioritization (Impact analysis of safety signals) •Risk Management Planning and Pharmacoepidemiology• Vaccine PV •Pharmacoepidemiology •Application of Pharmacoepidemiology in PV •Clinical Trial designs- Experimental and Observational study designs (Randomized Clinical trials, Descriptive studies, Cross-sectional studies, Cohort studies, Case-Control studies and Case Only designs)•Critical Appraisal of Clinical trials

• Which languages does Rahul Madan speak? 

  Rahul Madan speaks the following languages:
  No languages available.

• Which industries has Rahul Madan previously worked in?   

  Rahul Madan has prior experience in the following industries:
  Bayer Pharmaceuticals , Parexel , Parexel , Bristal Healthcare

• What is Rahul Madan’s work experience?  

  Rahul Madan has the following professional experience:
  Iqvia , Bayer Pharmaceuticals , Parexel , Parexel , Bristal Healthcare .

• How can I find Rahul Madan on LinkedIn?  

  You can view Rahul Madan’s
  LinkedIn profile at LinkedIn URL.

• What are Rahul Madan’s work email addresses?  

  Rahul Madan’s work email addresses are
  [email protected] .

• What company does Rahul Madan work for?  

  Rahul Madan works at
  Iqvia