Basic Info

Naveed Court

5 years

Hyderabad, India

Master's Degree

Manager

Work Experience

Assistant Manager Pharmacovigilance at Dr.Reddy's Laboratories Ltd

Experience Details

Assistant Manager Pharmacovigilance

R&D/Science

Manager

• Manage end to end pharmacovigilance activities for two oncology drug based projects undergoing clinical phase III and one project under clinical phase I.
• SPOC for medical monitoring team and data management team for Pharmacovigilance activities for both the projects.
• Manage and monitor two registry (Real World Late phase) studies which are outsourced to other CRO’s and ensure that they are complaint to the regulatory submission and the contract as well.
• Manage and accountable of activities performed by indirect resources (contractual) and play my part as an independent contributor to the department.
• Act as LRPV (Local qualified representative for pharmacovigilance activities) for TGA and other CIS countries for submission of reports (ICSR’s and ARs).
• Preparation of safety manuals and safety management plans for the site and the study respectively.
• Manage the relevant day-to-day aspects of safety operation agreement with service provider for Pharmacovigilance activities.
• Monitor medical and scientific published literature articles received from the service provider relevant for the safety profile for assigned product(s).
• Coordinate, plan and perform analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
• Conduct safety data analysis in support of developing and updating safety sections of eCRF’s, regulatory documents, informed consent, annual reports, product labels, and other safety related documents.
• Responsible for ensuring PV service provider maintains DRL standards and expectations for process improvements/efficiencies whilst ensuring the daily safety operations maintains the highest quality standards.
• Provide support of developing and updating Investigator Brochures and study protocols
• Support in establishing pharmacovigilance system & process and lead efforts to improve and increase work efficiency applicable to the Safety Surveillance.
• Training the medical monitor and data management teams of different CRO with safety management plans.
• Preparing aggregate reports such as DSURs, PSURs (for certain countries), PADERSand PBRERs.
• Quality checks of SDEA’s and coordinating with the vendors for transmission of safety data.
• A part of Medical Affairs team for the Biologics handling the medical information/ requests/ enquiries from the physicians globally on our bio-similar molecules.
• Responsible for updating Dr.Reddy’s labels PIL and SPC with that of the innovators labels and make sure that no new updated safety information is missed per innovator label.
• Through knowledge of ARISg, used for generation of line-listings and safety data for preparation of periodic reports and SDEA compliance.
• Preparing SOPs, developing an robust PV system and making the system ready for any Inspection from a regulatory authority.
• Global safety database exposure on ARISg, Infrom, Quickr, SAP and assisting team for data migration and evaluation.
• Developing quality metrics for PV vendors and providing the feedback after a series of review on the services they provide for us.
• Participating in vendor audits and further complaince audits. Representating PV and facing the inspections from the regulatory authorities.
• Reviewing TFLs, providing and reviewing safety data for interim and final CSRs.


Company Details

Dr.Reddy's Laboratories Ltd (multinational)

Hyderabad, India

More than 1000 employees

Biotechnology , Pharmaceuticals

www.drreddys.com/

Aug 2015 to present (1 year 4 months)
Assistant Manager Pharmacovigilance at Dr.Reddy's Laboratories Ltd

Experience Details

Assistant Manager Pharmacovigilance

R&D/Science

Manager

• Manage end to end pharmacovigilance activities for two oncology drug based projects undergoing clinical phase III and one project under clinical phase I.
• SPOC for medical monitoring team and data management team for Pharmacovigilance activities for both the projects.
• Manage and monitor two registry (Real World Late phase) studies which are outsourced to other CRO’s and ensure that they are complaint to the regulatory submission and the contract as well.
• Manage and accountable of activities performed by indirect resources (contractual) and play my part as an independent contributor to the department.
• Act as LRPV (Local qualified representative for pharmacovigilance activities) for TGA and other CIS countries for submission of reports (ICSR’s and ARs).
• Preparation of safety manuals and safety management plans for the site and the study respectively.
• Manage the relevant day-to-day aspects of safety operation agreement with service provider for Pharmacovigilance activities.
• Monitor medical and scientific published literature articles received from the service provider relevant for the safety profile for assigned product(s).
• Coordinate, plan and perform analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
• Conduct safety data analysis in support of developing and updating safety sections of eCRF’s, regulatory documents, informed consent, annual reports, product labels, and other safety related documents.
• Responsible for ensuring PV service provider maintains DRL standards and expectations for process improvements/efficiencies whilst ensuring the daily safety operations maintains the highest quality standards.
• Provide support of developing and updating Investigator Brochures and study protocols
• Support in establishing pharmacovigilance system & process and lead efforts to improve and increase work efficiency applicable to the Safety Surveillance.
• Training the medical monitor and data management teams of different CRO with safety management plans.
• Preparing aggregate reports such as DSURs, PSURs (for certain countries), PADERSand PBRERs.
• Quality checks of SDEA’s and coordinating with the vendors for transmission of safety data.
• A part of Medical Affairs team for the Biologics handling the medical information/ requests/ enquiries from the physicians globally on our bio-similar molecules.
• Responsible for updating Dr.Reddy’s labels PIL and SPC with that of the innovators labels and make sure that no new updated safety information is missed per innovator label.
• Through knowledge of ARISg, used for generation of line-listings and safety data for preparation of periodic reports and SDEA compliance.
• Preparing SOPs, developing an robust PV system and making the system ready for any Inspection from a regulatory authority.
• Global safety database exposure on ARISg, Infrom, Quickr, SAP and assisting team for data migration and evaluation.
• Developing quality metrics for PV vendors and providing the feedback after a series of review on the services they provide for us.
• Participating in vendor audits and further complaince audits. Representating PV and facing the inspections from the regulatory authorities.
• Reviewing TFLs, providing and reviewing safety data for interim and final CSRs.


Company Details

Dr.Reddy's Laboratories Ltd (multinational)

Hyderabad, India

More than 1000 employees

Biotechnology , Pharmaceuticals

www.drreddys.com/

Aug 2015 to present (1 year 4 months)
Executive pharmacovigilance at IMedglobal corporation

Experience Details

Executive pharmacovigilance

Pharmaceutical

Entry Level

• Case processing of clinical trial and study cases with OTC, Cosmetic, Commodity, Consumer products and Medical devices including their PQC’s and malfunction of devices.
• Clinical study cases and market research cases (Reformulation studies) processing from triage, data entry, peer review (Quality check) and case closure after submissions and case analysis part is done.
• Study cases including both marketed and non-marketed cases from NA and ROW (APAC, LATAM, and EMEA) region are databased after validation of report.
• Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from non-marketing sources for completeness and regulatory compliance with respect to Clinical Trail cases for Cosmetics and OTC products.
• Perform case processing (ICSR’s) and ensuring that the case is processed as per the source document by including all the elements reported.
• Generating concise, accurate and well-written case narratives.
• Establishing the causality between the event and the suspected drug with the client specific conventions followed as the SOP.
• Performs consistent coding of adverse events according to the project-specific coding conventions through MedDRA and confining to the MTS: PTC.
• Coordinating with the LSO and MSO for the follow-up and missing medical information.
• Perform the quality review of all the serious cases and a portion of non-serious cases irrespective of the reportability of the case.
• Forwarding the expedited reportable clinical trial and study serious cases to the regulatory submission specialist and regulatory affairs department.
• A thorough knowledge of RSS V9.3 database and the work flow management from case entry till its closure.
• Peer reviewing (quality check) of the cases for meeting the quality expectations set by client and meeting the regulatory compliance (Timelines and SLA’s).
• Training the new associates on the process work flow and getting them certified for the case processing.
• Communicate with Clinical Operations and clients to ensure compliance with safety and Pharmacovigilance SOPs
• Tracking the safety data and communicating the same with the PV service providers.
• Assist in compilation of aggregate periodic reports i.e. PEBRER’s, PADER, etc.
• Assist in representation of Global Safety and Pharmacovigilance group at project team and client meetings.
• Writing company specific standard operating procedures and work instructions under the review of team lead.
• Maintain the trackers defect trackers, case tracers in order to meet the productivity output without missing any of the case either in their quality or the case closure timelines with respect to its submissions.
• Writing CAPA, setting metrics to reach the CAPA closure.


Company Details

IMedglobal corporation (multinational)

Bangalore, India

101-500 employees

Healthcare and Medical Services, Pharmaceuticals , Marketing and Advertising

http://www.imedglobal.com/

Apr 2014 to Aug 2015 (1 year 4 months)
Drug safety associate at Regent Ajanta Biotech

Experience Details

Drug safety associate

R&D/Science

Entry Level

• Bookin cases and case processing into the ARGUS safety database and ensuring that the data is entered in all the data elements, performing an E2B validation check before the case is being routed further.
• Perform spontaneous case processing (ICSR’s) and ensure that the case is processed as per the source document completely and consistently.
• Perform literature search with the help of key words in the available data bases and get the publications with valid AE and perform the case processing.
• Generating concise, accurate and well-written case narratives.
• Coding the medications through WHO Drug Dictionary and the company drug dictionary.
• Establishing the causality between the event and the suspected drug from the source document, if provided or by employing various methods in generating a valid causality.
• Following reporting considerations for Follow-up cases.
• Performs consistent coding of adverse events, history and medical information according to the project-specific coding conventions through MedDRA.
• Participate in assisting and monitoring the queries of other associates during Case processing in the absence of Lead.
• Review and assess all source documents and maintain their consistency.
• Auditing and providing timely feedback for the cases reviewed. Submitting timely reports relating to Adverse Events and Product Complaints to the client.
• Maintaining Defect Trackers and other trackers to track all the cases which are completed and pending in the work flow.
• Quality review of cases processed and publishing the QR feedback which forms the quality of the team.
• Checking for listed/unlisted events as per the RSI provided in the database.
• A thorough knowledge of Argus Safety v7.0 and the work flow management.
• Performing quality assurance of cases to authenticate accuracy of cases booked-in and Product Complaints as per the Standard Operating Procedures.
• Leaded a team of 6 as a part of UAT testing for safety database migration from the operations end.


Company Details

Regent Ajanta Biotech

Roorkee, India

51-100 employees

Biotechnology

N/A

Jul 2012 to Apr 2014 (1 year 9 months)
Production Executive-trainee (intern) at Regent Ajanta Biotech

Experience Details

Production Executive-trainee (intern)

R&D/Science

Student

N/A


Company Details

Regent Ajanta Biotech

Roorkee, India

51-100 employees

Pharmaceuticals

N/A

May 2011 to Jul 2011 (2 months)
Volunteer at National conference on leadership (student activity)

Experience Details

Volunteer

R&D/Science

Student

N/A


Company Details

National conference on leadership (student activity)

Hyderabad, India

N/A

Jan 2010 to Jan 2010 (1 month)

Achievements


Team building responsibility and addition have given training for two batches with new joinees.
Have been assisting the management and representing the team in client audits and meetings,


Have won several awards in the competitive exams and secured various national and state level ranks in science and mathematics exams Have presented posters and papers in international pharmaceutical symposiums and conferences.

Education

MBA in Marketing

Education Details

MBA

Marketing, Human Resource

Jawaharlal Nehru Technological University, India

B / Very Good / 75 - 85%

Pharmaceutical Marketing, Human resource Finance

N/A

Jawaharlal Nehru Technological University
2012 - 2014
B.Pharmacy in Pharmacy

Education Details

B.Pharmacy

Pharmacy, Pharmacology, Pharmaceutical Business management

Osmania University, India

B / Very Good / 75 - 85%

Pharmacy Pharmaceutics Pharmacology Pharmaceutical Business Management

N/A

Osmania University
2008 - 2012
High School - Other

High School Details

Other

Dr.Jyothirmayi College

India

2007

A / Excellent / 85 -100%

This is regarding the intermediate studies in which Biology, Physics and Chemistry were the subjects.

Dr.Jyothirmayi College
2007

Certifications

Certificate details

Registered Pharmacist

Apr 2013

N/A

N/A

N/A

Pharmacy council of India

N/A

Certificate details

MS office proficiency

Jan 2005

91 out of 100

N/A

N/A

Aptech Computers

N/A

Certificate details

Pharmacovigilance

Aug 2014

N/A

N/A

N/A

Dubai Health Authority

N/A

Certificate details

Good clinical practices

Mar 2016

N/A

N/A

N/A

Arkus research

N/A

Certificate details

Management of adverse events

Sep 2014

N/A

N/A

N/A

Dubai Health Authority

N/A

Training and Courses

Training/Course Details

Production executive-Internship

Jul 2011

Regent Ajanta Biotech pharma company

was appointed as an production executive- internship for about 3 months and have been exposed to the product environment and the quality control steps taken in an pharmaceutical company.

Training/Course Details

Pharmacovigilance

Aug 2014

Online training

N/A

This profile is fresh!
Last update 19 days ago.

Jobseeker photo

Profile Skills and Keywords

AnalyticalArabicAssistant Manager PharmacovigilanceBiotechBiotechnologyCollecting And Updating The New Things On The Work I DoCommunicatorDr.Reddy's Laboratories LtdDrug Safety AssociateEnglishExecutive PharmacovigilanceGadgetsGood Clinical PracticesHard WorkerHealthcareHealthcare And Medical ServicesHindiHuman ResourceIMedglobal CorporationInnovativeMBAMS OfficeMS Office ProficiencyManagement Of Adverse EventsMarketingMarketing And AdvertisingMedical Claims And Medical MarketingMedical MarketingMicrosoft SQL ServerPharmaceuticalPharmaceutical Business ManagementPharmaceuticalsPharmacologyPharmacovigilancePharmacyProduction Executive-InternshipProduction Executive-traineeR&DRegistered PharmacistSASScienceSupportiveTeluguTravellingUrduVBAVolunteer

Self-assesed Skills

Languages

English

English

: Fluent

: Fluent

: Fluent

: Fluent

Urdu

Urdu

: Fluent

: Fluent

: Fluent

: Fluent

Telugu

Telugu

: Fluent

: Fluent

: Fluent

: Fluent

Hindi

Hindi

: Fluent

: Fluent

: Fluent

: Fluent

Arabic

Arabic

: Advanced

: Intermediate

: Beginner

: Beginner

Tools and Technologies

Pharmacovigilance

Pharmacovigilance

: Expert

: Extreme - I love it!

:

1-3 years

MS office

MS office

: Advanced

: Extreme - I love it!

:

5-7 years

Microsoft SQL Server

Microsoft SQL Server

: Intermediate

: Extreme - I love it!

:

1-3 years

SAS

SAS

: Intermediate

: Extreme - I love it!

:

1-3 years

VBA

VBA

: Beginner

: Extreme - I love it!

:

1-3 years

Fields of Expertise

Pharmacovigilance

Pharmacovigilance

: Expert

: Extreme - I love it!

:

1-3 years

Medical marketing

Medical marketing

: Expert

: Extreme - I love it!

:

1-3 years

Healthcare

Healthcare

: Advanced

: Extreme - I love it!

:

1-3 years

Medical claims and medical marketing

Medical claims and medical marketing

: Advanced

: Extreme - I love it!

:

1-3 years

Key Skills

Analytical, Communicator, Hard worker, Innovative, Supportive

Online Presence

www.facebook.com/naveedpharmaco

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