Medical Safety Expert
8 hours 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
1 week ago
Hyderabad, Telangana, India Novartis Full time**Summary**: Provide support for medical safety management within the Patient Safety & Pharmacovigilance department, including medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co - authoring safety documents, assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority...
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Senior Medical Safety Expert
2 weeks ago
Hyderabad, Telangana, India Novartis Full timeSummary -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...
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Medical Safety Lead
4 days 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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▷ Apply Now: Safety Signal Expert
2 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 Ensures optimal patient safety for assigned compounds by identifying new safety signals early using internal and external spontaneous reporting...
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Group Lead
1 week ago
Hyderabad, India Dr Reddy's Laboratories Limited Full timeJob DescriptionJob summary We are seeking a seasoned individual to provide crucial medical oversight for clinical trials, ensuring ICH GCP (International Conference on Harmonization Good Clinical Practices) and protocol compliance, prioritizing subject safety, and contributing to the success of biopharmaceutical advancements. The ideal candidate will play a...
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Associate 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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Group Lead
2 weeks ago
Hyderabad, Telangana, India Dr. Reddy's Laboratories Full timeCompany Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20...
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Medical Safety Writer- Aggregate Reports
2 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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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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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...
