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Medical Lead In Clinical & Medical Affairs

Alvotech
Alvotech
5+ years
Not Disclosed
Bangalore, Remote
10 March 13, 2026
Job Description
Job Type: Full Time Remote 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

Medical Lead – Clinical & Medical Affairs

Company: Alvotech
Location: Bangalore Office / India Home Office (Partially Remote)
Job Type: Full-Time
Application Deadline: March 15, 2026
Job Requisition ID: JR100086

Experience Required
Minimum 5+ years of professional medical and clinical research experience, including at least 2 years of clinical practice in a hospital or healthcare setting with direct patient care and a minimum of 3 years of experience working as a Safety Physician or Medical Lead in clinical development or pharmacovigilance environments. Candidates should also have at least 2 years of experience supporting or working on clinical trials within a pharmaceutical company, biotechnology organization, or Contract Research Organization (CRO).

Education Qualification
Doctor of Medicine (MD) is mandatory. Only candidates with a recognized medical degree will be considered.

About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused on the development and manufacturing of high-quality biosimilar medicines. Within the Research and Development (R&D) division, the integrated Clinical and Medical Research (iCMR) department develops strategies aligned with biosimilar guidelines and global health authority requirements to support successful clinical studies and post-marketing activities. The department continues to modernize and optimize its operating model to support efficient global clinical development.

Job Overview
The Medical Lead – Clinical & Medical Affairs is a medically qualified expert responsible for providing medical oversight and scientific input across assigned clinical development programs and post-marketing activities. The role involves close collaboration with the pharmacovigilance team and Clinical Development Lead (CDL) to ensure patient safety and effective clinical program execution throughout the product lifecycle.

This position focuses particularly on monitoring patient safety during the post-marketing phase while also supporting clinical development activities such as clinical trial monitoring, medical review, and regulatory interactions.

Key Responsibilities
Provide medical input across the product lifecycle while collaborating with cross-functional clinical teams and project teams.
Lead and contribute to post-marketing safety activities including medical review of Individual Case Safety Reports (ICSRs).
Support signal detection, signal evaluation, and pharmacovigilance safety monitoring activities.
Contribute to the preparation and review of aggregate safety reports and benefit–risk assessments.
Act as a medical monitor for clinical trials including those conducted through external Contract Research Organizations (CROs).
Provide medical interpretation of clinical data and support scientific decision-making for clinical programs.
Contribute to the preparation and review of essential clinical trial documents.
Support development and review of scientific publications and medical communications.
Participate in regulatory authority interactions when required.
Ensure compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) guidelines.

Required Skills and Competencies
Strong expertise in medical safety review including ICSRs, signal detection, signal evaluation, and benefit–risk assessment.
Demonstrated experience supporting clinical trials and medical monitoring activities.
Strong knowledge of global clinical development processes and pharmacovigilance systems.
In-depth understanding of international regulatory guidelines including ICH standards, GCP, and global pharmacovigilance regulations.
Excellent analytical and clinical data interpretation skills.
Strong communication and collaboration skills with the ability to work effectively in multicultural and cross-functional teams.

Preferred Qualifications
Experience working on biosimilar or biologic clinical development programs is desirable.
Previous experience working within pharmaceutical companies, biotechnology organizations, or CRO environments supporting global clinical trials.

Additional Requirements
Ability to work independently while managing multiple clinical and safety activities.
Strong organizational, leadership, and problem-solving skills.
Commitment to maintaining patient safety, regulatory compliance, and scientific excellence throughout the product lifecycle.