Medical Reviewer

2+ years

Not Disclosed

Pune Remote

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Company Description
At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. Our vision is to create a healthier world. How? By empowering a global team of more than 7,000 employees to deliver next-generation commercialization services to the life sciences industry. We serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our solutions help bring innovative therapies to market and support the patients who depend on them. Together, we make an impact every day.

We embrace diversity in backgrounds and experiences. Improving patient lives globally is our priority, and we need people from all walks of life to help us shape the future of healthcare and life sciences. Our inclusive culture and cultural beliefs drive our success. We seek team members who not only excel in their own skills but also care deeply about EVERSANA, our people, clients, and most importantly, the patients we serve. We are EVERSANA.

Job Description

Position Overview
The primary responsibility of this position is to perform medical review, evaluation, and analysis of Individual Case Safety Reports (ICSRs), assist clients with safety data, and ensure compliance with pharmacovigilance (PV) legislation and guidance.

Key Responsibilities

Perform medical review of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary, ensuring compliance with service level agreements and regulatory timelines.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as per regulatory requirements.
Serve as an internal consultant to pharmacovigilance case processing teams.
Possess a deep understanding of the scientific basis for therapies and drug-induced diseases, including knowledge of medical devices, vaccines, and the drug development process.
Maintain current knowledge of product portfolios and safety profiles across therapeutic areas.
Contribute to process improvement activities, including quality control process implementation.
Provide timely feedback to case processors regarding errors and discrepancies.
Assist in training and mentoring case processing and medical review personnel as required.
Stay updated on medical safety regulatory industry developments.

Job Expectations

Travel: <5%
Hours: 45 hours per week

Education and Experience

MBBS/MD/BDS/MDS required
1-2 years of experience as a Medical Reviewer for ICSRs in pharmaceutical, biotech, or medical device industries (CRO experience is a plus).
Expertise in regulatory guidelines and international regulatory requirements (FDA, ICH GCP, MHRA, PMDA, GVP Modules, EU Clinical Trial Directive).
Strong interpersonal, organizational, and communication skills.
Proficiency in MS Office applications (Outlook, Excel, Word, PowerPoint).

Additional Information
All your information will be kept confidential according to EEO guidelines.

Our Cultural Beliefs

Patient Minded: I act with the patient’s best interest in mind.
Client Delight: I own every client experience and its impact on results.
Take Action: I am empowered and empower others to act now.
Grow Talent: I own my development and invest in the development of others.
Win Together: I connect passionately with anyone, anywhere, anytime to achieve results.
Communication Matters: I create transparent, thoughtful, and timely dialogue.
Embrace Diversity: I create an environment of awareness and respect.
Always Innovate: I am bold and creative in everything I do.

EVERSANA Recruitment Fraud Awareness
Be aware of fraudulent job offers misrepresenting EVERSANA. Recruitment fraud is a scam that may use fake websites or unsolicited emails to request personal information or payment for training or job applications. EVERSANA would never ask for such information or payments.

Diversity and Inclusion at EVERSANA
We are an Equal Opportunity Employer, committed to diversity, equity, and inclusion. Our employees come from different backgrounds, experiences, and perspectives, contributing to our collective success.

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