Aarti Sharma

Global Regulatory Affair

Role: Assistant Manager Regulatory Affair at Gss Pharma Pvt.Ltd
Location: Bengaluru, KA, IN
LinkedIn followers: 500 followers

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Experience

Assistant Manager Regulatory Affair
Gss Pharma Pvt.Ltd
Oct 2019 — Present · IN

Education

HIMT COLLEGE OF PHARMACY, GREATER NOIDA
Mpharma
Jamia Hamdard
PGDPRA, Drug Regulatory affair
2014 — 2015
HIMT COLLEGE OF PHARMACY, GREATER NOIDA
Mpharma, Pharmaceutics
Patna St Michael School
10th
1994 — 2004
Patna University
12th
Maharishi arvind inst of pharmacy,jaipur
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
2008 — 2012

Skills

Regulatory Submissions
Sincere, Honesty, Hard Working, Eager to Learn New Things, Good Time Management
Pharmaceutical Research
Validation
Pharmaceutics
Pharmaceutical Sales
Chromatography
Hplc
Formulation
Pharmaceutical Industry
Sop
Fda
Biopharmaceuticals
Biotechnology
Dissolution
Pharmacology
Change Control
Glp
Organic Chemistry
Pharmacovigilance
Gmp
Regulatory Affairs
Lifesciences

Contact information

Verified work emails, personal emails, and direct dials — unlocked in one click.

Work email
•••••@gsspharma.com
Personal email
•••••@•••••.com
Direct dial
+•• ••• ••• ••••

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Current company

Gss Pharma Pvt.Ltd

Pharmaceutical Manufacturing · 30 employees · Founded 2015 · Bangalore, Karnataka, India

HEADED BY PROFESSIONALS WITH TWO DECADES OF EXPERIENCE IN THE FIELD OF PHARMA INDUSTRY WITH DIVERSE INTELLECTUAL CAPABILITIES COVERING MANUFACTURING AND EXPORTING OF FINISHED FORMULATIONS. GSS Pharma is the youngest and an emerging pharmaceutical company in the export market with its head office based in Bangalore, India. Our philosophy is to use innovative technology and provide superior quality products to its esteemed customers. We have professionally managed, well trained and technically qualified team comprised of capable and passionate people dedicated to deliver quality products and services. GSS Pharma is at its best in meeting the expectations of the customers with commitment to work and uncompromised quality objective. We cater to a diversified pharmaceutical market with more than 400 formulations covering a wide range of therapeutic segments, including psychotropic and controlled substances with global presence in more than 20 countries. Our facilities are capable of producing dosage forms like Tablets, capsules, Eye/Ear and Nasal drops, Creams and Injectables. GSS Pharma provides Pharmacovigilance services to Pharmaceutical companies globally at best prices in the industry. Our end-to-end Pharmacovigilance services include but not limited to:* QPPV assistance.* Global literature monitoring of molecules by using Distiller and Medical literature monitoring from EMA.* Triage, Data Entry, Quality review and Medical review and submission of ICSRs downloaded from Eudravigilance portal, spontaneous cases, and cases from global literature search.* Submission of Risk management plan as part of initial dossier submission and updates to the same.* Preparation and submission of PSUR/PEBRER and EURD list check.* Signal detection and evaluation.* Annual SmPC review for clients.* Update of SmPC in XEVMPD after the receipt of grant from Health Authority.* EMA account management.* Addendum to clinical overview (ADCO) with clinical expert statement.

gsspharma.com

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Experience

Assistant Manager Regulatory Affair

Education

HIMT COLLEGE OF PHARMACY, GREATER NOIDA

Jamia Hamdard

HIMT COLLEGE OF PHARMACY, GREATER NOIDA

Patna St Michael School

Patna University

Maharishi arvind inst of pharmacy,jaipur

Skills

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