Medical Safety Expert
3 weeks ago
Job Description Summary -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. Job Description Major accountabilities: - 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) Key performance indicators: - Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency and quality of safety deliverables Minimum Requirements: Work Experience: - People Challenges. - Managing Crises. - Functional Breadth. - Collaborating across boundaries. - Operations Management and Execution. - Project Management. Skills: - Clinical Research. - Clinical Trials. - Functional Teams. - Literature Review. - Medical Records. - Process Safety. - Regulatory Compliance. - Safety Science. Languages : - English. Skills Desired Clinical Research, Clinical Trials, Functional Teams, Literature Review, Medical Records, Process Safety, Regulatory Compliance, Safety Science
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Medical safety expert
2 weeks ago
Hyderabad, India Novartis Full timeJob Description Summary-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...
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Medical safety expert
2 weeks ago
Hyderabad, India Novartis Full timeJob Description Summary-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...
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Medical Safety Lead
4 weeks ago
Hyderabad, Telangana, India Novartis Full timeSummary In close collaboration with the Global Program Safety Lead GPSL provides robust safety evaluation expertise and medical innovation in order to improve patients lives and impact on overall Novartis results As a member of the Medical Safety organization prioritizes the safety of patients ensures optimal patient safety for assigned compounds and shares...
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Medical Expert
2 weeks ago
Hyderabad, Telangana, India Novartis Full time**Summary**: The Medical Expert in TCO (Translational Clinical Oncology) is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical co-leadership for assigned aspects of one or more global, active, TCO study, under the leadership of a Clinical Program Leader...
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Medical Expert
2 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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Hyderabad, Telangana, India Novartis Full time ₹ 6,00,000 - ₹ 12,00,000 per yearJob Description SummaryThis role combines responsibilities in Medical Safety Operations (addressing pharmacovigilance (PV) needs) with Project Management activities. Reporting to the Head Medical Safety (MS) Processes & Projects, the MS Processes and Projects (MS P&P) Manager is responsible for planning of deliverables associated with MS owned processes and...
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Hyderabad, Telangana, India Novartis Full time ₹ 8,00,000 - ₹ 24,00,000 per yearSummaryThis role combines responsibilities in Medical Safety Operations (addressing pharmacovigilance (PV) needs) with Project Management activities. Reporting to the Head Medical Safety (MS) Processes & Projects, the MS Processes and Projects (MS P&P) Manager is responsible for planning of deliverables associated with MS owned processes and other key...
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Medical Safety Writer- Aggregate Reports
5 days 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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Hyderabad, India Seven Consultancy Full timeJOB DETAILS 1) Lead preparation of global periodic safety reports for newly launched products. Lead coordination with GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements. 2) Independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Hospital...
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Safety Physician
2 weeks ago
Hyderabad, Telangana, India Precision for Medicine Full time**Position Summary**: The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company, including oversight of...
