Description

 

 

 

MOHAMMED SHAJIUDDIN NAVEED

A dynamic and focused team manager offering a successful career spanning over 10+ years in the Pharmacovigilance domain with broad knowledge in PV project management, project quality management and client-vendor management. Ability to work on numerous projects with an eye on detail and with an in-depth understanding.
+91 7588427328

[email protected]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROFILE SUMMARY
–         Possess in-depth knowledge of Case Management, Alliance and Vendor Management, and Quality and Document Management. Direct the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials.

–         Acquired sound Understanding of ICSR reports (spontaneous, non-interventional studies, literature, PMS, and CT reports) In-depth knowledge of ICH guidelines, drafting SOPs and SWIs on the basis of the safety sections of protocols, investigator brochures, clinical study reports, INDs, NDAs, and other documents and ensure that the documents are appropriate, feasible, operational and accurately reflect the safety and/or risk-benefit profile (as appropriate).

–         Comprehensive knowledge of PV activities and deliverables, throughout the product lifecycle, required to support and maintain product benefit-risk profile. Ability to describe nature and communicate the impact of these activities to other non-PV professional’s stakeholders.

Analytical
Proficient ability to connect the dots quickly between strategies and decisions; Skilled in asking the right questions and proactively anticipating information needed to inform business decisions/actions.

–         Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility.

 

ACHIEVEMENTS
–         Actively involved in MHRA Audit at TCS, and NPA audit at Cognizant Technology Solutions, got appreciation from Directors, Managers and project lead. Client-certified Process trainer

–         5 best team member awards

–         3 WOW awards

 

EDUCATION
–         Master of Pharmacy (Pharmaceutics)

SRTMU Nanded, Maharashtra |Summer 2009

 

–         Bachelors of Pharmacy

SGB University, Amravati, Maharashtra | Summer 2007

 

EXTRA CURRICULAR ACTIVITIES
–         Paper Presentation at “International Conference on Drug Discovery and Nanotechnology” held at Nanded.

–         Poster Presentation at “60th Indian Pharmaceutical Congress” held at Delhi

–         Actively Participated in College and university-level literary events.
CORE COMPETENCIES
Project and Vendor Management & Execution

 

DSUR, PBRER, RMP

Safety Data Review SDRM()SDRMMeetings (SDRM)

 

ICSR, medical review, PV &DV

 

Risk Management

Safety Management Team ompliances

 

SOP/SWI Writing Experiences

 

Site Establishment and Project Transition

 

Team Management

 

 

 

 

SOFT SKILLS
Communicator
Intuitive
Planner
Detail-oriented

Motivator
CERTIFICATION
–       IPC Certificate for paper presentation

–       Paper presented at international conference

 

 

 

 

 

Career Timeline (Recent Companies)
Orcimed Lifesciences, Hyderabad.

Team Manager
Cognizant Technology Solutions Hyderabad.

Team Manager
Tata Consultancy Services, Mumbai

Senior Associate
 

 

 

 

WORK EXPERIENCE
 

From Jan’24 as Team Manager, OrciMed Lifesciences Hyderabad.

Responsibilities:

Managing 100+ team members. End to end PV operations with ICSR, literature, Reporting team and associated process (Mailbox). Client/Vendor Management. QMS. RCA CAPA deviations.

 

Oct’14- Jan’24 COGNIZANT as

Team Manager

Responsibilities:

–         Directed the whole PV process with the ICSR team (35+), AR Team (7+) and the medical review team (7 Medics), ensuring timely submission of ICSR reports.

–         Run operational metrics reports on a routine basis, identify follow-ups required, and work with the appropriate PV Operations head and vendor lead to ensure appropriate follow-up is completed

–         Awareness of any conditions or obligations and other commitments relating to safety or the safe use of the products.

–         Ensure the conduct of PV and submission of all PV-related documents in accordance with the marketing company requirements and Good Pharmacovigilance Practice (GVP).

–         Govern the development, maintenance and review of internal procedures/processes to develop and evolve the PV system with evolving business needs and regulatory requirements.

–         Perform regular and continuous improvement initiatives through routine review of key performance and productivity indicators, CAPAs/deviations related to the PV system, and wider internal organization quality management system.

–         Oversight of key PV wider vendors on system performance and management.

–         Oversaw an ICSR team of over 30 people, including triage, case processing, and QC teams, as well as the creation of SOPs and SWI documentation and the management of client relationships.

–         Provide development opportunities and capability-building initiatives, promoting guidance and direction to the team to achieve objectives.

–         Contribute to the creation or development of PV Ops processes and written standards.

–         Collaborate with stakeholders (e.g., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations/Sciences/Development) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.

–         Work across a complex matrix environment to ensure compliance with internal standards and external regulatory requirements

–         Facilitate investigation into root cause, creation of corrective/preventative actions (CAPAs) revamping process or training issues and support with remediation of process/training needs.

–         Review and maintain oversight of PV Operations training materials.

–         Work with content owners and experts to prepare internal and external presentations as required.

–         Implement changes to PV Ops training curriculums in line with current PV Ops structure and maintain oversight of PV Ops training aspects.

PREVIOUS EMPLOYMENT
Sep 2012 – Oct 2014 | Tata Consultancy Services, Mumbai| Senior Associate

–         Played a pivotal role as a part of team member of PV case processing team, involved in triage till the execution of cases within the stipulated timeline

–         Data Entry Safety Associate – Responsible for complete processing of ICSRs with reference to source documents provided

–         Quality Reviewer- Reviewed ICSRs processed for accuracy of the data entry pertaining to standards/process conventions set. Accurately marked errors to associates for data missing in ICSR (if any)

–         Workflow Management- Responsible for case assignment to the team, TAT management of priority cases and monitored EOD status of the team. Conducted knowledge transfer sessions for the trainee associates to make them understand the process conventions.

 

July 2010 – June 2011 | Ajanta Pharma Ltd. Mumbai| Research Associate F& D

–       Accountable for doing research, planning, and executing new programs and processes in their form or organization, as well as supervising the creation of new items.

–       Performed studies of pre-formulation, formulation development, process characterization studies, and drug product formulation activities

–       Compilation of trial information, stability reports, analytical data, and a lab notebook.

 

PERSONAL DETAILS

Date of Birth:                          30th April 1980

Languages Known:  English, Hindi, Urdu, and Marathi

Address:                  H.No. 9-4-1311B58 Noor Manzil, Nadeem Colony, Tolichowki, Hyderabad 500008, Telangana state.

Passport No:                  W7682297

 

 

 

MOHAMMED SHAJIUDDIN NAVEED

 

A dynamic and focused team manager offering a successful career spanning over 10+ years in the Pharmacovigilance domain with broad knowledge in PV project management, project quality management and client-vendor management. Ability to work on numerous projects with an eye on detail and with an in-depth understanding.
+91 7588427328

[email protected]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROFILE SUMMARY
–         Possess in-depth knowledge of Case Management, Alliance and Vendor Management, and Quality and Document Management. Direct the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials.

–         Acquired sound Understanding of ICSR reports (spontaneous, non-interventional studies, literature, PMS, and CT reports) In-depth knowledge of ICH guidelines, drafting SOPs and SWIs on the basis of the safety sections of protocols, investigator brochures, clinical study reports, INDs, NDAs, and other documents and ensure that the documents are appropriate, feasible, operational and accurately reflect the safety and/or risk-benefit profile (as appropriate).

–         Comprehensive knowledge of PV activities and deliverables, throughout the product lifecycle, required to support and maintain product benefit-risk profile. Ability to describe nature and communicate the impact of these activities to other non-PV professional’s stakeholders.

Analytical
Proficient ability to connect the dots quickly between strategies and decisions; Skilled in asking the right questions and proactively anticipating information needed to inform business decisions/actions.

–         Sound decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility.

 

ACHIEVEMENTS
–         Actively involved in MHRA Audit at TCS, and NPA audit at Cognizant Technology Solutions, got appreciation from Directors, Managers and project lead. Client-certified Process trainer

–         5 best team member awards

–         3 WOW awards

 

EDUCATION
–         Master of Pharmacy (Pharmaceutics)

SRTMU Nanded, Maharashtra |Summer 2009

 

–         Bachelors of Pharmacy

SGB University, Amravati, Maharashtra | Summer 2007

 

EXTRA CURRICULAR ACTIVITIES
–         Paper Presentation at “International Conference on Drug Discovery and Nanotechnology” held at Nanded.

–         Poster Presentation at “60th Indian Pharmaceutical Congress” held at Delhi

–         Actively Participated in College and university-level literary events.
CORE COMPETENCIES
Project and Vendor Management & Execution

 

DSUR, PBRER, RMP

Safety Data Review SDRM()SDRMMeetings (SDRM)

 

ICSR, medical review, PV &DV

 

Risk Management

Safety Management Team ompliances

 

SOP/SWI Writing Experiences

 

Site Establishment and Project Transition

 

Team Management

 

 

 

 

SOFT SKILLS
Communicator
Intuitive
Planner
Detail-oriented

Motivator
CERTIFICATION
–       IPC Certificate for paper presentation

–       Paper presented at international conference

 

 

 

 

 

Career Timeline (Recent Companies)
Orcimed Lifesciences, Hyderabad.

Team Manager
Cognizant Technology Solutions Hyderabad.

Team Manager
Tata Consultancy Services, Mumbai

Senior Associate
 

 

 

 

WORK EXPERIENCE
 

From Jan’24 as Team Manager, OrciMed Lifesciences Hyderabad.

Responsibilities:

Managing 100+ team members. End to end PV operations with ICSR, literature, Reporting team and associated process (Mailbox). Client/Vendor Management. QMS. RCA CAPA deviations.

 

Oct’14- Jan’24 COGNIZANT as

Team Manager

Responsibilities:

–         Directed the whole PV process with the ICSR team (35+), AR Team (7+) and the medical review team (7 Medics), ensuring timely submission of ICSR reports.

–         Run operational metrics reports on a routine basis, identify follow-ups required, and work with the appropriate PV Operations head and vendor lead to ensure appropriate follow-up is completed

–         Awareness of any conditions or obligations and other commitments relating to safety or the safe use of the products.

–         Ensure the conduct of PV and submission of all PV-related documents in accordance with the marketing company requirements and Good Pharmacovigilance Practice (GVP).

–         Govern the development, maintenance and review of internal procedures/processes to develop and evolve the PV system with evolving business needs and regulatory requirements.

–         Perform regular and continuous improvement initiatives through routine review of key performance and productivity indicators, CAPAs/deviations related to the PV system, and wider internal organization quality management system.

–         Oversight of key PV wider vendors on system performance and management.

–         Oversaw an ICSR team of over 30 people, including triage, case processing, and QC teams, as well as the creation of SOPs and SWI documentation and the management of client relationships.

–         Provide development opportunities and capability-building initiatives, promoting guidance and direction to the team to achieve objectives.

–         Contribute to the creation or development of PV Ops processes and written standards.

–         Collaborate with stakeholders (e.g., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations/Sciences/Development) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.

–         Work across a complex matrix environment to ensure compliance with internal standards and external regulatory requirements

–         Facilitate investigation into root cause, creation of corrective/preventative actions (CAPAs) revamping process or training issues and support with remediation of process/training needs.

–         Review and maintain oversight of PV Operations training materials.

–         Work with content owners and experts to prepare internal and external presentations as required.

–         Implement changes to PV Ops training curriculums in line with current PV Ops structure and maintain oversight of PV Ops training aspects.

PREVIOUS EMPLOYMENT
Sep 2012 – Oct 2014 | Tata Consultancy Services, Mumbai| Senior Associate

–         Played a pivotal role as a part of team member of PV case processing team, involved in triage till the execution of cases within the stipulated timeline

–         Data Entry Safety Associate – Responsible for complete processing of ICSRs with reference to source documents provided

–         Quality Reviewer- Reviewed ICSRs processed for accuracy of the data entry pertaining to standards/process conventions set. Accurately marked errors to associates for data missing in ICSR (if any)

–         Workflow Management- Responsible for case assignment to the team, TAT management of priority cases and monitored EOD status of the team. Conducted knowledge transfer sessions for the trainee associates to make them understand the process conventions.

 

July 2010 – June 2011 | Ajanta Pharma Ltd. Mumbai| Research Associate F& D

–       Accountable for doing research, planning, and executing new programs and processes in their form or organization, as well as supervising the creation of new items.

–       Performed studies of pre-formulation, formulation development, process characterization studies, and drug product formulation activities

–       Compilation of trial information, stability reports, analytical data, and a lab notebook.

 

PERSONAL DETAILS

Date of Birth:                          30th April 1980

Languages Known:  English, Hindi, Urdu, and Marathi

Address:                  H.No. 9-4-1311B58 Noor Manzil, Nadeem Colony, Tolichowki, Hyderabad 500008, Telangana state.

Passport No:                  W7682297

 

Candidate Last Salary : 2,00000-More Than
Candidate Role / post : Assistant Manager
Candidate DOB : 30 Apr 1980
Candidate Phone : 7588427328
Candidate Total Experience : More than 10 Years
Candidate Gender : Male

Education

School of Pharmacy

2007 Master of Pharmacy