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Summary

- diligent & result-oriented professional, with 10+ years of experience across Pharmaceutical Industry; with exceptional academic credentials, currently spearheading as research Scientist in one of the world leading brand wockhardt. - highly motivated, quick learner and success oriented professional seeking a challenging position in Clinical research operation & Project Management. i am confident of my ability and can outstand as a professional in the company which requires me to utilize the skills, abilities and experience to ensure the company’s success. - all-round competencies in Clinical research domain including all fine aspects covering - Operations, investigational product (ip), quality audits, regulatory audits, Documentation, in-process Quality Assurance and research Analysis. good knowledge across various clinical science)" >Protocol areas. - ability to conceptualize the processing for Project Management & sophisticated Quality Assurance measures in Compliance to specified standards while performing root-cause Analysis to prevent any reoccurrences & defects. skillset :- - Medical writing on projects & literature search. - investigational products, bioequivalence studies (study Coordinator); - monitoring 50 be studies in different CRO’s. - maintaining ich-gcp guidelines. - have a flair for keeping abreast with global regulatory guidelines & the latest technologies. - adequate knowledge of the storage of different pharmaceutical products. trainings:- - foundations of Clinical research & gcp conducted by academy for clinical excellence, mumbai in 2004. - fundamentals of GMP & gcp by vanzeyl international in 2006. - generic drugs: opportunities, challenges and trends by indian drug manufacturers association in 2008. - oral presentation on Clinical research in india at 54th ipc 2002. - poster presentation on evaluation of antiseptic & wound healing activity of different essential oils at 54th ipc 2002.

Experiences

Current Experience

  • R&D Scientist


    Since February 2006
    key responsibilities:- - responsible for Pharmacy related activities like ip receipt & accountability for bioequivalence studies (be). - performing dispensing of ip for be studies and to ensure archival of ip & destruction of archived ip as per SOP & regulatory guidance. - to ensure safe and quality use of medicines, handling of Quality Systems (change controls, deviations, a team Member for internal audits etc. - reviewed all documents & faced internal/ external audits. coordinate with the qa to ensure the document initiation and closure related to the instrument Qualification, sops, science)" rel="nofollow">Protocol & deviation documents Compliance. - preparation and review of SOP of glp and calibration data of various instrument/s. - excellent interpersonal, Communication and organizational skills with proven abilities leading motivated teams towards achieving organizational goals. - perform early and final database qc activities, also responsible for the safety and proper conduct throughout the trial/s. - verifying that the Investigator follows the approved science)" rel="nofollow">Protocol and all gcp procedures and initiation of project in consultation with technical experts. - handling be studies in healthy human volunteers for various regulatory agencies like usfda, mhra. - providing Training in regards to science)" rel="nofollow">Protocol, SOP to new recruits and to ensure the Compliance in accordance with gcp and SOP is maintain throughout. key achievements:- - credentials of handling successful clearance of usfda for ranitidine, diclofenac sodium & misoprostol fdc, pramipexole dihydrochloride & piloglitazone.  - to ensure Compliance of Operations with governing regulatory requirements. liaise with the sponsor and act as a primary point of contact for specific Report Writing activities.  - efficiently managing the compilation of screening & study related documents in res. tmf& quality check for the same. preparation of usfda inspection for Pharmacy & faced it successfully. Key Responsibilities:- - Responsible for Pharmacy related activities like IP receipt & accountability for Bioequivalence Studies (BE). - Performing Dispensing of IP for BE Studies and to ensure Archival of IP & destruction of Archived IP as per SOP & Regulatory Guidance. - To ensure safe and quality use of medicines, handling of Quality systems (Change controls, Deviations, a team member for internal audits etc. - Reviewed all documents & faced internal/ external audits. Coordinate with the QA to ensure the document initiation and closure related to the instrument qualification, SOPs, protocol & deviation documents compliance. - Preparation and review of SOP of GLP and calibration data of various instrument/s. - Excellent interpersonal, communication and organizational skills with proven abilities leading motivated teams towards achieving organizational goals. - Perform early and final database QC activities, also responsible for the safety and proper conduct throughout the trial/s. - Verifying that the investigator follows the approved protocol and all GCP procedures and initiation of project in consultation with technical experts. - Handling BE studies in healthy human volunteers for various regulatory agencies like USFDA, MHRA. - Providing training in regards to Protocol, SOP to new recruits and to ensure the compliance in accordance with GCP and SOP is maintain throughout. Key Achievements:- - Credentials of handling successful clearance of USFDA for Ranitidine, Diclofenac sodium & Misoprostol FDC, Pramipexole dihydrochloride & Piloglitazone.  - To ensure compliance of operations with governing regulatory requirements. Liaise with the Sponsor and act as a primary point of contact for specific report writing activities.  - Efficiently managing the compilation of screening & study related documents in res. TMF& quality check for the same. Preparation of USFDA Inspection for Pharmacy & faced it successfully.

Past Experience

  • Clinical Research Associate (CRA)

    October 2005 --- January 2006
    key responsibilities:- -responsible for managing the team while Training them for the professional and work developments. managed team’s concerns and grievances while providing them with various accolades to motivate them on regular basis - reviewed all documents & initiate internal/ external audits. coordinate with the qa to ensure the document initiation and closure related to sops, science)" rel="nofollow">Protocol & deviation documents Compliance  - coordination of be studies for various regulatory agencies like usfda & mhra.  - co-ordination of screening activity and enrolment of Volunteer in database with a Volunteer management team.  - instrumental in icf (Informed Consent form) presentation for general screening and study related procedure of bioequivalence study.  - efficiently managing the compilation of screening & study related documents in res. tmf & quality check for the same. key achievements:- - presentation for general screening and study related procedure of bioequivalence study.  - co-ordination of screening activity and enrolment of Volunteer in database with a Volunteer management team.

  • Research associate

    January 2004 --- September 2005
    key responsibilities:- - work as a team player and develop others through discussion. - establish safe, productive environment by means of company’s Policy and procedures. - efficiently maintained science)" rel="nofollow">Protocol designing for bioequivalence studies; after finalization submit it to the iec for its approval. - scheduling & coordinating pre-study site visit with sponsor/CRO’s representative. - monitoring Clinical phase of bioequivalence studies; ensuring that appropriate data is reported; oversaw more than 50 be studies in different CRO’s in india. - instrumental in preparing / monitoring checklist along with SOP for handling the ba/be studies.  - coordination of bioequivalence studies for various regulatory agencies like usfda, anvisa.  - handling other bioequivalence studies related activities for the sponsor such as Investigator selection, study initiation activities, study termination activities, final study report development& supervision of other CRA’s. key achievements:- - monitoring Clinical phase of bioequivalence studies; ensuring that appropriate data is reported; oversaw more than 50 be studies in different CRO’s in india. - coordination of bioequivalence studies for various regulatory agencies like usfda, anvisa.  - efficiently maintained science)" rel="nofollow">Protocol designing for bioequivalence studies; after finalization submit it to the iec for its approval.  - handling other bioequivalence studies related activities for the sponsor such as Investigator selection, study initiation activities, study termination activities, final study report development& supervision of other CRA.

Personality

Self Assessment :
Attention to detailCoordinationInterest in knowledge

Knowledge

LinkedIn Assessment :
Clinical researchCROSOPLive experience on Argus safety databaseMedical writingFDAClinical Research AssociatesResearch scientistsBio-equivalence StudiesICH-GCPSOPPharmaceutical IndustryGCPGood Clinical Practice (GCP)Standard Operating Procedure (SOP)

Skills and Expertise

Self Assessment :
Monitor a clinical studyCoordinate projects

Education

  • M.Pharm in Pharmaceutical Sciences from Dr. M.G.R Medical University, Chennai. in 2003
  • Bachelor of Pharmacy (B.Pharm.) in Pharmaceutical Sciences from Swami Ramanand Teerth Marathwada University in 2000

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Hindi
Native

Work Preferences

  • Positions I am interested in:
    Clinical Research Senior Clinical Research Associate (CRA) Clinical Project Leader Clinical Research Manager
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Aurangabad, Maharashtra, India

Others

Driving License
  • No

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