Profilbillede af mann1305
@mann1305
Flag for India Ahmedabad, India
Medlem siden 17. december 2010
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mann1305

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- Management of the SAE reports from a medical, regulatory, and administrative standpoint - Review of SAEs in the Safety Database - Coding of AEs and SAEs in the Clinical Database - Preparation of event narratives - Review of the SAEs for administrative and medical consistency; including requesting follow up and clarification information from the investigator - Submission of SAE reports to the relevant local operating unit - Contribute to the training of the members of a study team (including CRA, study coordinators) involved in the clinical research as far as Safety and Pharmacovigilance are concerned - Development of Pharmacovigilance Master File (PVMF) as per EU Regulation - Contribute to the Writing of SOPs - Submitting expedited reports and individual case safety reports - Provide oversight and supervision of periodic literature searches regarding AEs reported in the local and foreign literature. - Preparation of PADER and PSUR - Preparation of summary tabulation - Provide support to investigator for preparation and updation of Investigator Brochure, Package Insert and/or SPC, Risk Evaluation and Mitigation Strategy (REMS) - Responding to queries regarding the safety profile of marketed products
$4 USD/hr
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Nylige bedømmelser

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Erfaring

Research Associate

Apr 2010

- Management of the SAE reports from a medical, regulatory, and administrative standpoint - Review of SAEs in the Safety Database - Coding of AEs and SAEs in the Clinical Database - Preparation of event narratives - Review of the SAEs for administrative and medical consistency; including requesting follow up and clarification information from the investigator - Submission of SAE reports to the relevant local operating unit - Contribute to the training of the members of a study team (including CRA, s

Uddannelse

M. Pharma

2005 - 2008 (3 years)

Kvalifikationer

Seminar certificate (2006)

PES Institute of Medical Sciences

National seminar on "Challenges and Opportunities posed by Biotechnology and IPR" on 20th and 21st January 2006.

Seminar & Workshop (2006)

PES Institute of Medical Sciences

Seminar and workshop on Drug Design and Pharmacogenomics on 15th June 2006.

Journal club presentation (2005)

PES College of Pharmacy

Delivered a Journal club presentation on, A novel orally active inhibitor of HLE organized by PES College of Pharmacy, Bangalore

Workshop (2005)

PES Institute of Medical Sciences

Workshop on "Research Methodology" organized by PES Institution of Medical Sciences, Kuppam

Seminar (2005)

PES Institute of Medical Sciences

Seminar on "Biostatistics: Application in Clinical Research" at Institution of Medical Sciences, Kuppam on June;1,2,3-2007.

Publikationer

Ocimum Sanctum And Its Therapeutic Applications

In Indian mythology the plant is considered to extirpate all sins and purify the body when touched. It is often grown outside dwellings and worshipped daily. It is said to daunt Yama, the god of death, but has a close affinity with Lord Krishna who is reputed to have grown the herb. If offered to Lord Krishna it is said to have mystical powers of protection from death, disease and misfortune. Therapeutic Application of Ocimum Santum For fulltext please refer [login to view URL]

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