Drug Safety Admin Associate Ii
8 months ago
Coordinates the timely review of serious and non-serious adverse events; tracks all necessary data and generates reports for the client, project team and/or external vendors.
- Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
- Manages project training and the set-up archival of files; ensuring PVG remains audit ready.
- Performs data entry into internal/external database tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively project timelines.
- Oversees expenses and manages translations, ensuring budget parameters are not exceeded.
- Supports any specific activities performed office, which cannot be performed from elsewhere.
- Provides training to junior staff.
- In collaboration with Safety Specialist, Medical Monitors and Regulatory Publishing Specialist liaises and establishes effective relationships with internal team members to implement projects, coordinate and facilitate meetings. manage all incoming safety documentation, and accurately manage regulatory documents submissions, filing, and redactions.
- Provides support and coordination of regulatory publishing documents.
- Assists in reviewing document quality when tracking regulatory publishing data in internal systems and uploading in internal and/or external electronic trial master files.
- Ensures redactions for Commercially Confident Information and Personal Data for regulatory publishing is maintained.
- Assist in maintaining the upkeep of licenses within internal and/or external system for users across projects within IT Security standards.
- Assist with archiving of regulatory publishing documents and submissions.
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Drug safety physician
1 month ago
Bengaluru, India Biocon Biologics Full timeWe are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...
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Drug Safety Physician
1 month ago
Bengaluru, India Biocon Biologics Full timeWe are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...
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Drug Safety Physician
1 month ago
Bengaluru, India Biocon Biologics Full timeWe are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...
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Junior Drug Safety Associate
2 days ago
Bengaluru, Karnataka, India Indegene Full timeLooking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...
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Senior Drug Safety Technology Strategist
2 weeks ago
Bengaluru, Karnataka, India Lifelancer Full timeAbout the RoleWe are seeking a Senior Drug Safety Technology Strategist to join our team at Lifelancer. As a key member of our organization, you will be responsible for delivering solutions in line with the Drug Safety roadmap with a focus on improving efficiency.ResponsibilitiesDevelop and implement technology strategies to support business objectives in...
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Senior Drug Safety Systems Engineer
1 week ago
Bengaluru, Karnataka, India Lifelancer Full timeAbout the Job">We are seeking an experienced Senior Drug Safety Systems Engineer to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT.Job Description">As a Senior Drug Safety Systems Engineer, you will be responsible for delivering solutions in line with the Drug Safety roadmap, focusing on improving efficiency...
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Drug Safety Expert I
6 months ago
Bengaluru, Karnataka, India Novo Nordisk Full timeDrug Safety Expert I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety GBS (GS - GBS).- **The Position** - A Drug Safety Expert will be responsible to ensure all the conventions are followed by safety case handlers and would drive quality deliverables, he or she would act as a bridge...
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Bengaluru, India Oracle Full timeJob Description `Overview of the Organization Oracle Life Sciences GIU (LSGIU) provides industry leading solution to Life Sciences organizations including pharmaceutical companies, CROs (Contract research Organizations), Academic research and Healthcare providers that include care providers, IDN (integrated delivery networks), public regional/national...
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Drug Safety Surveillance Specialist
2 weeks ago
Bengaluru, Karnataka, India Lifelancer Full timeJob OverviewThis role involves providing critical support to the Life Sciences RD vertical at Accenture, focusing on pharmacovigilance services. The successful candidate will be part of a team that helps biopharma companies bring their vision to life by converging scientific expertise with unique insights into patient experience.About the RoleIn this...
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Senior Software Engineer
2 weeks ago
Bengaluru, Karnataka, India Lifelancer Full timeAbout LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT that connects talent with opportunities.Job Title: Senior Software Engineer - Global Drug Safety Data PlatformsWe are seeking a highly skilled Senior Software Engineer to join our team in Bengaluru, India. This role will involve delivering solutions for Global Drug Safety...
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Quality Assurance Analyst
2 weeks ago
Bengaluru, India Growel Softech Pvt. Ltd. Full timePayroll - QA Analyst Job Description : The candidate should be adaptive to a continuous changing and fast paced environment, be able to successfully multi-task, and thrive in a dynamic, fully engaged QA role. The role will involve interacting with clients in the Business, developers, external vendors, and other QA teams. Ready to attack any challenge,...
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Medical Admin Assistant Ii
7 months ago
Bengaluru, India ICON Full timeAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
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Bengaluru, Karnataka, India Lifelancer Full timeJob DescriptionAt Lifelancer, we are committed to connecting talented professionals with exciting opportunities in the life sciences industry.We are seeking a highly experienced Global Pharmacovigilance Leader to join our team. In this role, you will be responsible for leading safety signal detection, assessment, and risk management activities for our global...
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Associate Regulatory Professional Ii
6 months ago
Bengaluru, Karnataka, India Novo Nordisk Full timeAssociate Regulatory Professional II **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**:EU Submissions Hub- Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living...
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Safety Writer
7 months ago
Bengaluru, India Elixir Consulting Full timeLocation - Bangalore- Industry - Other- Contract Type - Permanent- Salary - ₹ 11,000,000- Published - 5 days ago - Contact - Reference - 29-25-10137- Academic title - Bachelor of ScienceJob description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and...
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Research Associate Ii
4 months ago
Bengaluru, Karnataka, India BAXTER Full time**Vantive: A New Company Built On Our Legacy** Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...
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Safety Science Coordinator Ii
3 months ago
Bengaluru, Karnataka, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Safety Science Coordinator Ii
1 month ago
Bengaluru, Karnataka, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in...
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Product Safety Specialist II
2 weeks ago
Bengaluru, Karnataka, India CSA Group Full timeJob OverviewCSA Group is seeking a Product Safety Specialist II to join our team in Bangalore. As a Product Safety Specialist II, you will be responsible for providing high-quality certification in accordance with Medical devices product safety standards.ResponsibilitiesIndependently manage certification projects concurrently ensuring compliance with all...
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Research Associate Ii
6 months ago
Bengaluru, Karnataka, India BAXTER Full time**Vantive: A New Company Built On Our Legacy** Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney...