Summary
Overview
Work History
Education
Skills
Professional Skills
Additional Information
Certification
Interests
Personal Information
Work Availability
Quote
Timeline
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Dr Rahul Arora

MBBS, DEM, Sigma SIX Black Belt
Chandigarh

Summary

"Highly experienced and Seasoned Drug Safety Physician with a strong background in Pharmacovigilance and team management. 10 Years of experience in the Pharmacovigilance, including 5 Years of team management. Have honed expertise in performing medical reviews of Individual Case Safety Reports (ICSRs) of all case types and conducting Signal Detection activities on aggregate data. In addition, I excel at training and mentoring new recruits, and have served as a GSO for Signal Detection activities. Clinical experience of over 4 years in various Multi-Speciality Hospitals, as well as 2 years of experience as a Medical Superintendent/Hospital Administrator, have provided a unique perspective on patient safety and regulatory compliance. A dedicated and efficient professional who is passionate about contributing to team success through hard work, attention to detail, and excellent organisational skills. With a strong motivation to learn, grow, and excel in the industry, and committed to error prevention and continuous improvement

Overview

15
15
years of professional experience
10
10
years of post-secondary education
16
16
Certifications

Work History

Manager Drug Safety Physician

Parexel International India Pvt Ltd
Chandigarh
05.2013 - Current
  • Responsible for ICSR and Signal Detection involve overseeing medical review of Individual Case Safety Reports (ICSRs) and ensuring same processed appropriately. This includes evaluation of adverse events and drug interactions, as well as determining causality and severity of event.
  • Responsible for timely and accurate completion of medical reviews of ICSRs, and for providing guidance and training to drug safety scientists to assist with processing of ICSRs and Clinical Study Reports (CSRs).
  • Responsible for signal detection activities such as conducting aggregate analyses and evaluating safety signals. This includes reviewing data from various sources, such as spontaneous reports, clinical trials, and published literature, and performing signal detection-related analyses and reports.
  • Working closely with cross-functional teams to ensure proper handling of safety signals, including development and implementation of Risk Management Plans (RMPs) and appropriate communication with regulatory authorities.
  • Other key responsibilities included monitoring and assessing safety profile of assigned drugs, maintaining knowledge of regulatory requirements and guidelines for safety reporting, and participating in internal and external safety review committees.
  • Involved in preparation and review of safety sections of clinical trial protocols and other regulatory documents.
  • Involved in for project management tasks, assisting in analytical and critical project management, managing all aspects of project including budget setting, staff management, recruitment, planning and scheduling activities, managing resources, monitoring progress according to client's requirements, and being primary contact for client communication.
  • Responsible for team management of team of Drug Safety Physicians for all operational tasks
  • Responsible for setting goals for staff, assess individual performance and achievements according to company HR processes, manage people development and talent management, and perform regular reviews for team members and provide appropriate feedback.
  • Responsible for ensuring data collection and preparation of metrics is provided to senior management on regular basis.
  • Work Load management and establishment of capacities and distribute work as per incoming workflow.
  • Responsible for planning daily, monthly, and annual work capacities for team, and conduct refreshers and training
  • Interaction with internal or external Stake holders to resolve issues related to processing of ICSRs
  • Liaison with Project Manager/Team Leads to understand training needs of team members, as required
  • Involved in Business Contingency Planning, Pandemic Planning and Inspection Readiness
  • Training of new PV scientist (MedDRA and Expectedness)
  • Hiring, Training and mentoring of New Physicians.
  • Providing medical inputs in processing of individual case safety reports (ICSRs) and SAE narrative writing.
  • Responsible for Medical review of SAE/CSR narratives
  • Undergone Training in Aggregate periodic safety data reports including Periodic Safety Update
  • Reports (PSURs, PBRER's etc.).
  • Assessing events for coding, MedDRA coding of adverse events company causality assessment using various methods as per client requirement.
  • Triage of Local and Global Literature articles.
  • Performing RCA using different methods and management in Trackwise both internal and client
  • Involved in Business Contingency Planning, Pandemic Planning and Inspection Readiness
  • Training of new PV scientist (MedDRA and Expectedness)
  • Training and mentoring of New Physicians.
  • Performing Signal detection activities for 3 year
  • Experience in carrying out review and analysis of search results for Signal detection
  • Assessing events for coding, MedDRA coding of adverse events.
  • Medial review of Individual Case Safety Reports (ICSRs).
  • Providing medical inputs in processing of individual case safety reports (ICSRs) and SAE narrative writing.
  • Medical review of SAE/CSR narratives
  • Undergone Training in Aggregate periodic safety data reports including Periodic Safety Update Reports (PSURs, PBRER's etc.).
  • Hands on experience in setting up AI for expectedness and Literature search engine

ICU Resident and Hospital Administrator

NINS Brain AND SPINE hospital
Chandigarh
08.2008 - 05.2013
  • Job Responsibilities:
  • Handling emergencies and roadside traumas.
  • Handling OPD in absence of CONSULTANTs.
  • Managing critically ill patients.
  • Assisting in OT procedures and handling minor OT procedures.
  • Taking care of step downs in ICU.
  • Putting RT and ET Tube in case of emergencies.
  • Putting central venous lines in case of emergencies.
  • Responsible for diagnosing and treating variety of diseases and injuries in general practice.
  • Conducting fitness physical examinations.
  • Assisting in various procedures in OT.
  • Ordering or executing various tests, analysis, and diagnostic images to provide information on patient's condition.
  • To analyze reports and findings of tests and examinations of patients.
  • Responsible for Inoculating and providing vaccinations to patients to immunize them from communicable diseases.
  • Responsible for rounds in wards and to put updated notes in files.
  • Counseling patients and attendant.
  • Managing duty rosters of doctors and Staff Nurses.
  • Handling administrative work like recruitments, dealing with insurance companies.
  • Managing discharge of patients.
  • Maintain records for hospital.
  • Oversaw staffing operations, including recruitment, hiring and evaluation of administrative staff, nurses and doctors.
  • Acted as liaison among governing boards, medical staff and department heads.
  • Developed procedures and strategies for quality assurance, patient services, departmental activities and public relations.
  • Organized, directed and coordinated medical and health services according to organizational policies and goals
  • Communicated with doctors, nurses, patients and other employees to identify and resolve healthcare needs.
  • Coordinated with other healthcare providers concerning treatment plans for patients.
  • Remained educated on emerging healthcare technologies and wrote proposals for possible purchases of new equipment to stay at forefront of innovation.
  • Monitored and notified senior management on expenditures and plans concerning budget and fiscal matters.
  • Responded to inquiries from doctors, nurses and patients with accurate information.
  • Recruited, hired and coached employees to offer high-quality, cost-effective care to all residents.
  • Defined testing protocols, quality assurance initiatives and clinic policies and procedures.
  • Conducted routine facility inspections, identifying areas needing improvement and eliminating hazards posed to staff and residents for continued compliance with associated regulations.
  • Reviewed and evaluated test results to suggest care and treatment options.
  • Communicated with patients, ensuring that medical information was kept private.

Resident Medical Officer

Fortis Escorts Hospital
Amritsar
01.2008 - 07.2008
  • Job Responsibility
  • Handling emergencies and roadside traumas.
  • Handling cardiac patients in Heart Centre
  • Taking care of step downs in ICU and CCU
  • To aid in putting IABP (Balloon Pumps)
  • Putting RT and ET Tube in case of emergencies
  • Responsible for diagnosing and treating variety of diseases and injuries in general practice.
  • Conducting fitness physical examinations
  • Ordering or executing various tests, analysis, and diagnostic images to provide information on patient's condition.
  • To analyze reports and findings of tests and examinations of patients.
  • Responsible for Inoculating and providing vaccinations to patients to immunize them from communicable diseases.
  • Responsible for rounds in wards and to put updated notes in files.
  • Handling AMBULANCE calls
  • Maintaining bridge between consultant and family of patient.
  • Wrote and updated patient prescriptions.
  • Collected information about patient histories, current conditions and vital statistics to make accurate determinations about conditions.
  • Educated patients about procedures, conditions and medications.
  • Provided routine and emergency medical care to patients.
  • Directed cost management, utilization management, quality assurance and medical protocol development initiatives.

Resident Medical Officer

Care Well Super Specialty Hospital, Amritsar
Amritsar
03.2008 - 06.2008
  • Job Responsibility
  • Handling emergencies and roadside traumas.
  • Managing cardiac emergencies
  • Looking after ICU and CCU
  • Putting RT and ET Tube in case of emergencies
  • Putting IV lines in case of emergencies
  • Handling minor OT procedures
  • To diagnose and treat variety of diseases and injuries in general practice.
  • Conducting fitness physical examinations
  • Ordering or executing various tests, analysis, and diagnostic images to provide information on patient's condition.
  • To analyze reports and findings of tests and examinations of patients.
  • Attending patients in hospital, prescribing treatment and re-examining disability cases periodically to verify progress.
  • Responsible for Inoculating and providing vaccinations to patients to immunize them from communicable diseases
  • Responsible for rounds in wards and to put updated notes in files.
  • Handling AMBULANCE calls
  • Maintaining bridge between consultant and family of patient.

Education

Bachelor of Medicine And Bachelor of Surgery -

Baba Farid University Of
Chandigarh
09.2002 - 12.2008

Fellowship in Emergency Medicine - Emergency Management

Appolo Hospitals
New Delhi
06.2013 - 05.2015

Secondary School Certificate -

Shivalik Public School
Chandigarh
03.1998 - 03.1999

High School -

DAV College
Chandigarh
03.2001 - 03.2002

Skills

Team Leader

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Professional Skills

  • Great knowledge of community medical diagnostic and patient are services in area of medical expertise.
  • Strong ability to supervise, advice, and train clinical professionals and students in area of expertise.
  • Sound knowledge of current principles, methods and procedures for the delivery of medical evaluation, diagnosis and treatment in area of expertise.
  • Excellent interpersonal and communication skills.
  • Sound ability to develop and present educational programs and workshops.
  • Effective verbal and written communication skills.
  • Strong ability to work both independently and in a team environment.
  • Can handle OPDS and IPDS individually
  • Have administrative skills to manage a hospital with an experience of more than 3 years

Additional Information

  • Was honored With Star Doctor of The Month By Fortis Escorts Hospital, Amritsar.
  • Participated in different Quiz and Games at during academic career.
  • Represented college at various levels in various sports and won many prizes at different levels.
  • Ranked among the top 3 trainers in Parexel for 2 consecutive years

Certification

Be A Better Manager By Motivating Your Team

Interests

Travelling

Gadget Geek

Technology

Music

Cooking

Personal Information

Father's Name : Dr S.L. Arora

Mother's Name: Mrs. Asha Arora

Date of Birth: 24th June 1983

Marital Status: Married

Nationality: Indian

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote

"Unless you have reached perfection, never say 'I am right'. And once you have reached perfection, you need not say 'I am right'."

Timeline

Project Managment Basics

03-2023

Building High Performance Teams NASBA

06-2022

Influencing Others

06-2022

Managing Teams

06-2022

Certified, Lean Sigma Six Black Belt

06-2022

Be A Better Manager By Motivating Your Team

05-2022

Boosting Your Team S Productivity

05-2022

Coaching Skills for Leaders and Managers

05-2022

Dealing With Difficult People In Your Office

05-2022

Leadership Practical Skills

05-2022

Management Foundations 5

05-2022

Managing Team Conflict

05-2022

Managing Team Creativity

05-2022

How To Survive Difficult Coworkers

04-2022

Diploma in Statistical reasoning and algorithms

06-2021

Diploma in Signal Detection

06-2020

Fellowship in Emergency Medicine - Emergency Management

Appolo Hospitals
06.2013 - 05.2015

Manager Drug Safety Physician

Parexel International India Pvt Ltd
05.2013 - Current

ICU Resident and Hospital Administrator

NINS Brain AND SPINE hospital
08.2008 - 05.2013

Resident Medical Officer

Care Well Super Specialty Hospital, Amritsar
03.2008 - 06.2008

Resident Medical Officer

Fortis Escorts Hospital
01.2008 - 07.2008

Bachelor of Medicine And Bachelor of Surgery -

Baba Farid University Of
09.2002 - 12.2008

High School -

DAV College
03.2001 - 03.2002

Secondary School Certificate -

Shivalik Public School
03.1998 - 03.1999
Dr Rahul AroraMBBS, DEM, Sigma SIX Black Belt