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Safety Physician
Alvotech
posted 1d ago
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Flexible timing
Key skills for the job
Job Description
Alvotech is looking to hire a dedicated and experienced Safety Physician to join our team. In this role, you will be involved in managing our Global Pharmacovigilance (PV) system and providing medical expertise to ensure patient safety and regulatory compliance. This is an exciting opportunity to work in a dynamic, collaborative environment and contribute to innovative projects in the pharmaceutical industry. If you have a medical degree, extensive experience in PV, and a passion for advancing medical science, we would love to hear from you.
Key Responsibilities:
Pharmacovigilance (PV) Activities:
- Provide medical expertise during post-marketing pharmacovigilance activities
- Involved in management of the Global PV system for post-marketing and clinical safety.
- Oversee case processing, regulatory submissions, and medical reviews.
- Involved in management of literature, internet, and digital media monitoring.
- Participate in signal and benefit-risk management, risk management, and report reviews.
- Ensure compliance with global PV and clinical safety legislation.
- Collaborate with internal and external stakeholders.
- Conduct training on PV processes and standards.
- Establish relationships with business partners and service providers.
- Review PV agreements and manage subscriptions.
- Monitor compliance and performance indicators.
- Prepare for audits and regulatory inspections.
- Implement corrective and preventative actions for PV system deviations.
- Improve department processes and update quality management systems.
Medical Activities:
- Provide medical expertise during clinical development.
- Review development plans, trial protocols, regulatory documents, and study reports.
- Conduct training on therapeutic areas and study procedures.
- Consult during medical data reviews and document protocol inquiries.
- Participate in regulatory interactions and safety report preparations.
- Manage medical input for approved molecules.
- Provide medical management to sites and answer protocol-related questions.
- Review listings, lab reports, and participant profiles.
- Ensure documentation of protocol inquiries and responses.
Qualifications & Skills:
- Medical degree (M.D.)
- Fluent in English
- 5+ years in the pharmaceutical industry with PV and medical knowledge
- Experience as a medical doctor in primary care or hospital settings
- Knowledge of safety databases (advantageous)
- Experience with biologic and combination products (advantageous)
- Thorough understanding of PV processes and regulations (ICH, GVP, GCP, CIOMS, 21CFR, etc.)
- Proficient with Microsoft Office and technical software (Adobe, SharePoint, DocuSign, Veeva suite, etc.)
- Independent worker with strong accountability
- Excellent time-management and communication skills
- Positive, team-oriented mindset
- Ability to work in a multicultural environment
- Willingness to travel internationally
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
International travel
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