Medical Safety Expert

Novartis

2-5 years

Not Disclosed

Hyderabad

10 Aug. 22, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Position: Pharmacovigilance Services Analyst
Specialization: Pharmacovigilance & Drug Safety Surveillance
Qualifications: Master of Pharmacy
Experience Required: 3 to 5 years

About Accenture:
Accenture is a global professional services leader with top-tier capabilities in digital, cloud, and security solutions. With extensive experience across more than 40 industries, we deliver comprehensive Strategy and Consulting, Technology and Operations services, and Accenture Song, supported by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 employees drive innovation daily, serving clients in over 120 countries. At Accenture, we harness change to create value and shared success for our clients, people, shareholders, partners, and communities. Explore more at www.accenture.com.

Role Overview:
As a Pharmacovigilance Services Analyst, you will support the Patient Safety & Pharmacovigilance department by contributing to medical safety management tasks. This includes conducting medical reviews and assessments of Individual Case Safety Reports (ICSRs), co-authoring safety documents, and assisting with regulatory and clinical documentation. You will play a key role in ensuring compliance with patient safety rules and regulatory requirements, developing and implementing metrics and tools for effective pharmacovigilance and medical devices vigilance.

Key Responsibilities:

Provide support for medical safety management, including medical reviews of ICSRs, assessment of literature cases, and authoring enhanced MAC.
Co-author safety documents, including PBRER, DSUR, Investigator Brochures (IB), and product labeling documents.
Assist with safety input for regulatory submissions, Health Authority queries, and internal review meetings.
Perform literature reviews, analyze medical data, and contribute to safety profiles and risk assessments.
Collaborate with Safety Leads and other global functions to optimize medical review processes and ensure compliance with standards and regulations.
Act as a Subject Matter Expert (SME) for Medical Function processes, supporting audit and inspection activities.
Contribute to cross-functional projects and training initiatives to enhance safety and pharmacovigilance practices.

Requirements:

Bachelor’s degree in Pharmacy, Nursing, PharmD, PhD, or Medical Degree (MBBS or MD).
Minimum of 24 months of experience in the pharmaceutical industry, particularly in safety document or medical writing.
Proficiency in MedDRA and WHO coding, clinical trial methodology, ICH GCP, and GVP guidelines.
Strong attention to detail, organizational skills, and ability to manage multiple tasks effectively.
Excellent communication skills and the ability to operate in a global, collaborative environment.
In-depth knowledge of human physiology, pharmacology, and the drug development process.
Technical understanding of biomedical/statistical concepts and problem-solving skills.
Proficient in creating spreadsheets, presentations, and working with safety databases.

Why Novartis?
At Novartis, we are committed to improving and extending people’s lives through innovative science and collaborative problem-solving. Our inclusive and flexible culture empowers employees to tackle the world’s toughest medical challenges with integrity and curiosity. Join us to make a meaningful impact and reinvent what’s possible in patient care.

Explore Opportunities:
If this role isn’t the perfect fit for you, but you’re interested in Novartis and our career opportunities, join our talent community at Novartis Network.

Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Company/Legal Entity: Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No

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