📋 Job Details at a Glance 📍 Location Hyderabad, India 🏢 Company Novartis 👥 Experience 3+ years 🎓 Qualification 3+ years. Relevant technical / engineering background 📅 Eligible Batch 2023, 2024, 2025, 2026 📄 Job Type Full Time 💰 Salary Not Disclosed 🏢 Industry Healthcare 🛠 Key Skills Medical Safety Assessment Regulatory Compliance Cross-functional Project Leadership Outsourcing Management Audit and Inspection Management Stakeholder Negotiation Head Medical Safety Assessment and External Engagement at Novartis — Full Details & How to Apply The Head Medical Safety Assessment and External Engagement role at Novartis in Hyderabad, India requires 3+ years of experience and offers direct oversight of medical safety operations, including audit and inspection management . This position is part of Hyderabad, India jobs with a focus on regulatory compliance and stakeholder negotiation , making it a key role in Head Medical Safety Assessment and External Engagement jobs . This role is critical for managing strategic planning and oversight of Medical Safety operations, ensuring compliance and quality in medical reviews. Responsibilities include leading cross-functional project leadership , managing outsourcing operations, and conducting stakeholder negotiations. The role directly impacts patient safety through structured medical safety assessments and regulatory adherence, with a focus on audit and inspection management processes. The job posting confirms that Novartis has a significant presence in Hyderabad, India , and this role is part of Novartis recruitment for leadership in medical safety. The position is structured to support operational excellence in medical reviews, with emphasis on regulatory compliance and external engagement activities. 2023, 2024, 2025, 2026 graduates with 3+ years. Relevant technical / engineering background and 3+ years experience are eligible. The salary is Not Disclosed , and the role is available in Hyderabad, India jobs with onsite work mode. Applicants will gain hands-on experience in Medical Safety Assessment , Regulatory Compliance , Cross-functional Project Leadership , Outsourcing Management , Audit and Inspection Management , and Stakeholder Negotiation . This role provides a clear progression path into senior healthcare operations, with exposure to external engagement and compliance frameworks within a global healthcare environment. 📊 Role Difficulty: Medium | Competition Level: Medium | Fresher Friendly: Yes NexisGrow.com features this opportunity as part of its curated non-tech job listings. All details are sourced from the official job posting. Apply online before the opportunity closes. Job Role & Responsibilities The Head Medical Safety Assessment and External Engagement at Novartis ensures regulatory compliance and audit and inspection management across medical safety activities, directly impacting patient safety and quality benchmarks in product lifecycle operations. Manages strategic planning of medical safety activities, aligning with regulatory compliance standards and quality benchmarks defined by Novartis internal protocols. Leads medical safety initiatives using cross-functional project leadership to streamline and standardize medical review processes across pharmacovigilance and regulatory teams. Collaborates with Pharmacovigilance and Regulatory Affairs teams to conduct comprehensive safety assessments using medical safety assessment protocols and regulatory compliance checklists. Analyzes audit and inspection metrics such as non-conformance rates and compliance gap scores to improve medical review accuracy and audit and inspection management outcomes. Owns outsourcing decisions by evaluating vendor capabilities in medical safety assessment and assessing performance against outsourcing management KPIs such as on-time delivery and error rates. Documents audit findings and safety assessments in structured reports, ensuring transparency and accountability to stakeholders using stakeholder negotiation frameworks. Negotiates safety assessment protocols with external partners, aligning on deliverables and timelines through stakeholder negotiation and regulatory compliance alignment. Monitors real-time compliance metrics from internal audits to ensure consistent adherence to regulatory compliance and audit and inspection management standards. This role demands direct ownership of safety outcomes, with every decision impacting patient safety , regulatory compliance , and audit and inspection management performance metrics. Required Skills & Technical Competencies The role requires a strong technical profile in medical safety assessment , regulatory compliance , cross-functional project leadership , audit and inspection management , and stakeholder negotiation to execute safety protocols and manage external engagements effectively. Technical Skills Medical Safety Assessment — advanced — used to evaluate patient safety risks and validate safety data in Novartis product documentation and pharmacovigilance reports. Regulatory Compliance — advanced — applied to ensure adherence to ICH E2A , FDA 21 CFR Part 312 , and EMA guidelines in medical safety operations. Cross-functional Project Leadership — intermediate — utilized daily to coordinate between Pharmacovigilance , Regulatory Affairs , and Medical Affairs teams for safety review workflows. Audit and Inspection Management — advanced — applied to manage audit requests, track non-conformance rates , and improve compliance metrics across medical safety functions. Outsourcing Management — intermediate — used to assess vendor performance in medical safety assessment tasks, evaluating KPIs such as turnaround time and error rate. Stakeholder Negotiation — intermediate — applied to finalize safety protocols with external partners, ensuring alignment on regulatory compliance and audit readiness standards. When showcasing these skills, emphasize specific tools like MedDRA , SPRINT systems, or audit tracking dashboards and highlight measurable outcomes such as reduced non-conformance rates or improved compliance scores . Eligibility Criteria This role is designed for candidates with a degree in life sciences or engineering , who have a technical foundation in medical safety and regulatory compliance processes. Must hold a degree in life sciences , biomedical engineering , or a related technical field with a minimum 60% CGPA . Eligible batches are 2023 , 2024 , 2025 , and 2026 , allowing recent graduates to apply academic knowledge in real-world medical safety settings. Minimum 3 years of relevant experience in medical safety, regulatory affairs, or quality assurance is required. Internship experience in medical safety or pharmacovigilance is an advantage and should be clearly documented. Academic performance of at least 60% is preferred to demonstrate technical competence in core subjects. Portfolio must include a project report or case study on a medical safety assessment or regulatory compliance task. Documentation & Portfolio Requirements Your resume must include a structured project portfolio with clear descriptions of medical safety assessment tasks, audit and inspection management activities, or regulatory compliance workflows. Include a specific example of a medical safety assessment you conducted, such as a MedDRA coding exercise or a regulatory compliance gap analysis , to demonstrate hands-on technical experience in medical safety assessment and audit and inspection management . Salary for Head Medical Safety Assessment and External Engagement at Novartis 💰 Compensation Not Disclosed The advertised compensation for the Head Medical Safety Assessment and External Engagement role at Novartis is Not Disclosed . The exact in-hand figure and any additional components are confirmed by the company during the offer or HR discussion stage. Recommended Courses & Preparation Tips for Head Medical Safety Assessment and External Engagement Upskilling with the right resources can significantly enhance your selection odds for the Head Medical Safety Assessment and External Engagement role at Novartis . Recommended Courses & Resources Stakeholder Negotiation — Mastering negotiation is crucial for effective stakeholder engagement in this role. Boost your profile with relevant certifications at NexisGrow GetCertified — strengthen your application before you apply. Common Mistakes to Avoid ❌ Failing to tailor the resume — Highlight relevant skills and experiences specific to medical safety. ❌ Neglecting to research Novartis — This can lead to uninformed interview responses. ❌ Overlooking teamwork and collaboration — Demonstrate these skills in past roles. ❌ Submitting a generic cover letter — Address the specific responsibilities of the role. ❌ Not preparing for regulatory compliance questions — Be ready for questions related to safety assessments. ❌ Underestimating negotiation skills — Recognize their significance in stakeholder engagement. Before You Apply — Checklist ✅ Research Novartis and its medical safety operations before applying. ✅ Tailor your resume to highlight relevant skills and experiences specific to the role. ✅ Prepare a cover letter that addresses the key responsibilities outlined in the job description. ✅ Ensure your academic performance meets the expectations stated in the job data. ✅ Gather any relevant certifications or documentation to support your application. ✅ Double-check application deadlines and ensure timely submission. ✅ Follow up on your application status through the provided channels. ✅ Prepare for potential interviews by reviewing common questions related to medical safety. Resume Tailoring & ATS Keywords for Head Medical Safety Assessment and External Engagement Optimizing your resume for ATS is crucial for standing out in the application process for this role. ATS Keywords to Include Medical Safety Assessment Regulatory Compliance Cross-functional Project Leadership Outsourcing Management Audit Management Stakeholder Negotiation Medical Review Processes Quality Assurance Pharmacovigilance Safety Protocols Team Leadership Compliance Metrics Resume Tips for This Role Highlight relevant experience in medical safety or regulatory roles to align with job requirements. Emphasize teamwork and collaboration skills, particularly in cross-functional settings. Include specific projects or internships that demonstrate your understanding of medical safety assessments. Optimize your resume with keywords from the job description to pass ATS filters. Avoid including unrelated work experience that does not pertain to medical safety or healthcare. Build an ATS-optimized resume for this role using NexisGrow Resume Builder — free for all job seekers. Pro Tip: Do not include unrelated work experience that does not pertain to medical safety or healthcare in your resume. How to Apply for Head Medical Safety Assessment and External Engagement at Novartis Apply Now — Novartis Visit the Novartis careers page and locate the job listing. Prepare your resume, ensuring it highlights relevant skills and experiences. Fill out the application form accurately, providing all requested information. After submission, expect a confirmation email regarding your application status. Track your application through the Novartis careers portal for updates. Applications reviewed on rolling basis — early submission recommended. Apply Now — Novartis NexisGrow.com does not charge any fees for job applications. Novartis Novartis is a healthcare company based in Hyderabad, India , operating in an on-site work mode. The company operates within the healthcare industry, offering roles focused on medical safety and regulatory compliance . The team leads medical safety initiatives, optimizes medical review processes, manages audit and inspection requests, and oversees outsourcing decisions. They drive cross-functional projects to ensure quality and compliance in medical safety operations. This role supports Novartis ’s mission by ensuring robust medical safety standards through effective oversight and stakeholder engagement. It offers freshers early exposure to critical healthcare operations and potential for internal mobility within a structured, safety-focused environment. Company Details Industry Healthcare Location Hyderabad, India Connect With Us Careers Apply Now Website 🔗 novartis.wd3.myworkdayjobs.com Frequently Asked Questions Interview · Role · Salary · Growth ? Who can apply for Head Medical Safety Assessment and External Engagement at Novartis? Eligibility Tap to expand + Answer Candidates with a relevant technical degree and from batches 2023-2026 are eligible. ? What technical skills are most important for this role? Skills Tap to expand + Answer Key skills include Medical Safety Assessment, Regulatory Compliance, and Cross-functional Project Leadership. ? What is the expected salary for this position? Salary Tap to expand + Answer Salary details are not disclosed, but competitive industry benchmarks apply. ? What should I expect after applying for Head Medical Safety Assessment and External Engagement at Novartis? Hiring Process Tap to expand + Answer The process typically involves application review, screening, and an interview. ? How should I prepare for Head Medical Safety Assessment and External Engagement interview at Novartis? Preparation Tap to expand + Answer Focus on understanding medical safety protocols and Novartis' operations. ? Is this role work from home, hybrid, or onsite? Work Mode Tap to expand + Answer This role is onsite in Hyderabad. ? What is the career growth after joining Novartis as Head Medical Safety Assessment and External Engagement? Growth Tap to expand + Answer Exposure to cross-functional projects can lead to advanced roles in medical safety. ? What should I highlight in my resume for this role? Resume Tap to expand + Answer Emphasize relevant skills, academic performance, and any practical experience in medical safety. ? Is there a last date to apply for this role? Application Tap to expand + Answer Application deadlines should be checked on the Novartis careers page. ? Is there a probation period at Novartis? Probation Tap to expand + Answer Probation details are not specified in the job description. ? What is the work culture like at Novartis? Culture Tap to expand + Answer The role is onsite, promoting collaboration within a dedicated team. ? Can freshers apply for this role at Novartis? Fresher Tap to expand + Answer Yes, freshers with the required qualifications are encouraged to apply. 🔗 Explore More on NexisGrow More jobs in Hyderabad Browse all Non-Tech jobs Latest Fresher jobs More jobs at Novartis Work From Home jobs Ready to Apply? Don't Miss This Opportunity! Apply only via the official link. NexisGrow.com charges zero application fees. 👉 Apply Now — Official Link NexisGrow.com does not charge any application or registration fees. Beware of fraudulent offers. Naukri ki baat, NexisGrow ke saath • NexisGrow.com