Wanted Regulatory Affairs Specialist - Bangalore @ Resolve

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Wanted Regulatory Affairs Specialist - Bangalore

Resolve
0 - 2 years
Hosur
4 months ago
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Job Description

Clinical trials is a crucial field in the pharmaceutical industry focused on drug safety. Professionals in this area monitor, assess, and prevent adverse drug reactions to protect public health.

Qualification & Specifications :

MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry).

2020 -2024 passed out

Skills Required:

Scientific Background: Degree in Pharmacy, Life Sciences, or Medicine.
Attention to Detail: Meticulous accuracy in data entry and documentation.
Analytical Skills: Ability to analyze data and identify safety signals.
Regulatory Knowledge: Understanding of Good Pharmacovigilance Practices (GVP) and other regulations.

Key Responsibilities:

Case Processing: Receive, document, and process reports of adverse drug reactions (ADRs) from various sources, ensuring accurate data entry into safety databases.
Signal Detection: Analyze safety data to identify new risks or trends associated with a drug.
Risk Management: Develop and implement strategies to mitigate identified risks, ensuring the drug's benefits outweigh its potential harms.
Regulatory Reporting: Prepare and submit safety reports (e.g., PSURs) to regulatory authorities, ensuring compliance with global guidelines.
Documentation: Create and maintain accurate and compliant scientific and regulatory documents, including Standard Operating Procedures (SOPs) and safety reports.

For more details contact

Nithila (HR)

9880650***

Mail to- **@re*********h.com

Job Classification

Industry: Education / Training
Functional Area / Department: Healthcare & Life Sciences
Role Category: Health Informatics
Role: Clinical Informatics
Employement Type: Full time

Contact Details:

Company: Resolve
Location(s): Hosur

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Keyskills: Medical Coding HCPCS Clinical Research CPT Medical Transcription CPC ICD Cpt Coding Pharmacovigilance Medical Terminology

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₹ 2-2.5 Lacs P.A

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Resolve

Resolve Itech Corp MEA Approved Overseas Recruitment Agency About the Company Resolve Itech (Resolveitech Corp) is a leading overseas healthcare service provider specializing in recruitment, licensing, and exam support for healthcare professionals seeking international opportunities. With a strong...

Wanted Regulatory Affairs Specialist - Bangalore @ Resolve

Home > Health Informatics