Pharmacovigilance Physician

🔥 16 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide medical oversight of pharmacovigilance activities and ensure compliance with SOPs, client directives, GCP, and regulatory requirements • Attend and present at sponsor meetings • Provide medical and pharmacovigilance consultation to clients and project team members • Support business development activities as needed • Manage medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle • Provide therapeutic and protocol training on assigned studies • Write and/or review safety sections of CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules • Scientifically review aggregate reports, contribute to label updates, assess literature, and support dossier maintenance and risk management activities • Medically review cases, adverse events of special interest, and serious adverse events • Perform data reviews and validate coding listings or full safety data to identify potential safety concerns • Review adverse event and serious adverse event data from solicited, spontaneous, and literature sources • Identify and investigate safety signals and contribute to management of assigned products’ benefit-risk profiles

🎯 Requirements

• Must be MD or equivalent or MBBS qualified graduate • 5+ years of experience in the pharmaceutical/biotech industry, including at least 2 years in pharmacovigilance/drug safety • Experience in clinical practice or academic medicine is a plus • Working knowledge of pharmacovigilance regulatory requirements and guidance documents • Ability to perform medical assessments of safety data from multiple sources • Experience authoring complex documents and contributing to regulatory submissions • Knowledge of adverse event reporting systems • Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus • At least 2+ years of experience in pharmacovigilance medical review activities • Clinical expertise with attention to detail, quality, and patient safety • Excellent medical knowledge of physiology and pharmacology • Understanding of clinical study objectives and the complete drug development process • Technical, analytical, organizational, problem-solving, multitasking, communication, and presentation skills • Ability to work independently and under pressure and prioritize sensitive, complex information • Proficiency in basic computer applications • Fluent spoken and written English • Excellent interpersonal, influencing, and team-building skills • Good understanding of FDA, ICH, EMA, and GCP guidelines • Working knowledge of safety databases, MedDRA, biostatistics, data management, and clinical operations procedures • Ability to mentor and train other staff

🏖️ Benefits

• Global team environment • Career development opportunities • Collaboration and professional development • Meaningful work contributing to health outcomes • Occasional domestic and international travel opportunities

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