Pharmacovigilance Services

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Global PharmaTek is an emerging CRO giving end-to-end solutions in Pharmacovigilance. Our pharmacovigilance team is comprised of industry professionals with deep experience in both direct patient care and industry-specific pharmacovigilance services, enabling us to deliver safety data of the highest quality.

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CRO Company www.globalpharmatek.com

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Pharmacovigilance Services Global PharmaTek is an emerging CRO giving end-to-end solutions in Pharmacovigilance. We offer an extensive variety of services in Safety and Risk Management which includes state of the art call centres , case preparing and processing, well-being reports of individuals, total safety detailing reports, signal detection and risk administration and management, and counselling all in support of our customers pre-advertise improvement and post-marketing exercises. www.globalpharmatek.com

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Expert Team in Pharmacovigilance . Our pharmacovigilance team is comprised of industry professionals with deep experience in both direct patient care and industry-specific pharmacovigilance services, enabling us to deliver safety data of the highest quality. Working globally, Global PharmaTek can provide integrated or standalone services to support product safety monitoring in compliance with regulatory requirements for safety surveillance in pre and post-approval settings www.globalpharmatek.com

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ICSR Case Management Post-Marketing Reports Clinical Reports Medico-Legal, Literature, E2b reports Case triage and review Data entry and MedDRA coding Adverse Event Labeling Narrative writing Medical Review SAE reconciliations ICSRs and submissions Safety Database hosting Legacy case transfer 24/7 AE call center www.globalpharmatek.com

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Aggregate Reporting PSURs/PBRERs and PADERs ASR, DSUR Signal Detection Ad Hoc Reports Generation of listings Integrated summaries of safety Regulatory report submissions to appropriate authorities Medication error and drug abuse/misuse reporting www.globalpharmatek.com

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Safety/IT Enabled Services Designing & development of global safety data repository, post migration & integration of safety data Implementation, validation, maintenance & upgrade of Argus applications Integration of medical dictionaries to Argus application Design, development & submission of regulatory, operational, analytical & custom reports Validated and up-to-date case processing platform in a secure environment. Infrastructure hosted on the cloud and maintained by Global PharmaTek Training on Argus www.globalpharmatek.com

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Literature Search and Review Literature searches Review of abstracts and articles Full-text articles procurement and translation Signal detection and analysis Adhoc or customized literature searches to meet specific needs www.globalpharmatek.com

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Signal Surveillance Activities Ongoing medical review and analysis of cases Aggregate analysis, including data mining Meta-analysis of published safety data Qualitative and statistical signal detection Signal evaluation, assessment and reporting Development of risk management and communication plans www.globalpharmatek.com

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For More Information Visit us @ http://www.globalpharmatek.com | Write us at info@globalpharmatek.com Our Presence USA 2025 Lincoln Highway, Suite 225 Edison, New Jersey 08817, USA. Phone: +1 732 543 7155 INDIA Uptown Cyberabad Building, Block-A, Plot-532 & 533, Sri Swamy Ayyappa Housing Society, Madhapur , Hyderabad-500081, Telangana. India Phone: +91 9059799848

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