Medical Safety Expert
2 weeks ago
Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.
- Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. -Assist in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection. -Perform literature review -Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests. -Perform follow up activities on Health Authority Assessment Reports. -Assist in providing safety input to Regulatory Affairs and clinical documents. Support maintenance and management of local deviations -Assist in evaluating and writing other safety deliverables as assigned -Provide support as needed for new indication submission (regulatory document safety input). -Prepare responses to internal safety requests and contribution to responses to external safety queries. -Act as Subject Matter Expert (SME) for Medical Operations/ Medical Function -Lead the training and mentoring of junior team members/colleagues -Distribution of marketing samples (where applicable)
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
- Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products’ life cycle. Provides safety support to the clinical development teams.
- Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. -Assist in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection. -Perform literature review -Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests. -Perform follow up activities on Health Authority Assessment Reports. -Assist in providing safety input to Regulatory Affairs and clinical documents. Support maintenance and management of local deviations -Assist in evaluating and writing other safety deliverables as assigned -Provide support as needed for new indication submission (regulatory document safety input). -Prepare responses to internal safety requests and contribution to responses to external safety queries. -Act as Subject Matter Expert (SME) for Medical Operations/ Medical Function -Lead the training and mentoring of junior team members/colleagues -Distribution of marketing samples (where applicable)
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Medical Safety Expert
4 weeks ago
Hyderabad, India Novartis Full time2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be...
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Expert Regulatory Writer
4 weeks ago
Hyderabad, Telangana, India Novartis Full time392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...
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Medical Safety Associate
4 weeks ago
Hyderabad, India Novartis Full time2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be...
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Medical Reviewer
4 weeks ago
Hyderabad, India ProPharma Group Full timeFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
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Medical Reviewer
1 month ago
hyderabad, India ProPharma Group Full timeFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
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Medical Safety Writer- Aggregate Reports
4 weeks ago
Hyderabad, India Novartis Full time2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety. - Your responsibilities include, but are...
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Associate Medical Expert
4 weeks ago
Hyderabad, India Novartis Full time108,000 people reimagining medicine for more than 799 million people globally. Be part of this journey by representing a group that delivers medical communication solutions across multiple franchises, business units and affiliates. Our services and customized solutions enhance the reach of clinical data about relevant therapeutic advancements and supports in...
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Safety Writer
4 weeks ago
Hyderabad, Telangana, India Novartis Full time2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety. Your responsibilities include, but are not...
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Medical Equipment Sales Executive
5 days ago
Hyderabad, Telangana, India Gowork placement service Full timeWe are currently seeking a driven Sales Executive to join our team, focusing on educating healthcare professionals and promoting the usage and safety of our unique and patented brand within hospitals, nursing homes, and other medical facilities. Responsibilities include conducting sales calls to doctors, pharmacists, corporate hospitals, and nursing homes...
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Medical Writer
4 weeks ago
Madhapur, Hyderabad, Telangana, India Makrocare Full time**Company Description**: **MakroCare** is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical,- Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New- Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,- Medical/Scientific Support and...
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Clinical Safety Contractor
4 weeks ago
Hyderabad, India NITZ Consulting Private limited Full time**NITZ Consulting private Limited Inc. (“NItz”) **is committed to providing quality service in the field of pharmacovigilance to clients. Our clients range from mid-size to small pharmaceutical companies located worldwide who are engaged in developing a proprietary pipeline of novel therapies for the treatment of solid tumors and hematological...
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Sr. Safety Specialist
1 week ago
hyderabad, India Statistics & Data Corporation (SDC) Full timeSr. Safety Specialist SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that...
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Safety Aggreg Report Spec 1
5 days ago
Thane District, Maharashtra, India IQVIA Full timeJob Overview Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions - Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. - Lead, author...
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Medical Officer
4 weeks ago
Hyderabad, India CSC Healthcare Full timeWe are looking for a Medical Officer to join our team and oversee the daily operations of our medical facility. Ultimately, you will work with various departments, Physicians and staff to ensure our medical facility operates as efficiently and effectively as possible. **Responsibilities** - Ensure that all healthcare regulations and safety standards are...
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Sales Executive
4 weeks ago
Gurgaon District, Haryana, India Euro Safety Solutions Pvt Ltd Full time**Job description** Requirement of Sales Executive/ Sr. Sales Managers for multiple locations: - Rudrapur/Zirakpur/Pune/Mumbai/Gujarat/Bangalore/Hyderabad demonstrated working experience in PPEs/Hand Gloves/ Hygiene Products/Medical Products/Safety Shoes. Experience-1-3 years **Salary**: ₹25,000.00 - ₹30,000.00 per month **Benefits**: - Cell phone...
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Medical Dosimetrist
1 day ago
hyderabad, India 0548 Varian Medical Systems Int’l (India) Pvt Ltd Full timeTogether, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers,...
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Medical Dosimetrist
1 day ago
Hyderabad, India 0548 Varian Medical Systems Int’l (India) Pvt Ltd Full timeTogether, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers,...
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Medical Dosimetrist
11 hours ago
hyderabad, India 0548 Varian Medical Systems Int’l (India) Pvt Ltd Full timeTogether, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers,...
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Medical Dosimetrist
7 days ago
Hyderabad, India 0548 Varian Medical Systems Int’l (India) Pvt Ltd Full timeTogether, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers,...
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Assistant Medical Superintendent
4 weeks ago
Hyderabad, India Star Hospitals Full timeManagement of all clinical operations of Hospital. - To assess and modify environment of the hospital for patients as well as employees safety. - To help for ISO, NABH etc Accreditation - To manage MCI, INC, ESI, ECHS and other inspections and make changes according to the requirement of responsible body - To organize camps. - Supervising all business...