Drug Safety Specialist Surveillance
3 days ago
The Idea candidate for the Drug Safety Specialist - Safety Surveillance and Risk Management Role's responsibility is as follows :
1. Supports the signal management process (i.e set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports etc) for the assigned product (s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Data from multiple sources are evaluated and authors the signal evaluation report and manages literature review for safety information.2. Prepares and maintains the Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS) including the risk minimization measures and is responsible for the monitoring of the effectiveness of risk minimization measures.3. Supports the process for responding to safety questions from regulatory authorities and partners in collaboration with service providers and crossfunctional teams4. Collaborates with aggregate report vendors having thorough oversight over scheduling, tracking, compliance and quality.5. Contributes to and leads initiatives for process improvement and consistency regarding aggregate reporting, signal management, risk management plan preparation and responding to ad-hoc safety questions6. Supports the review and provides inputs to the safety sections of CCDS, local labels, health hazard analysis, QA trend analysis, device hazard lists etc7. Follows good pharmacovigilance practices (ICH, Eudravigilance, local regulations etc).8. Participates and supports pharmacovigilance audit/inspection preparation and CAPA management.9. Prepares SOPs, working guidance and ensuring pharmacovigilance compliance.10. Follows document management as per good documentation practices and SOPs.11. Oversees and mentors Drug Safety Specialist12. Ensures compliance, reconciliation, and review of safety data exchange agreement between partners.13. Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization.14. Collaborates well with drug safety physician and cross-functional teams (medical leads, clinical operations) for assigned clinical studies including SMP preparation/review, protocol review, IB review, SAE/SUSAR review, review of safety sections of DSUR, ASR, CSR etc15. Understands, interprets, analyse and clearly presents scientific and medical data in verbal and written format.16. Includes knowledge of case processing, expedited reporting and safety database concepts17. Demonstrates leadership and interacts collaboratively and effectively in a team environment (including safety, clinical development, medical affairs, regulatory, commercial, and devices) as well as with external colleagues.18. Must be an excellent communicator and have strong negotiation skills with an ability to have oversight over CRO activities19. Strong organizational skills, including the capability to prioritize independently with minimal supervision.
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Drug Safety Specialist Surveillance
7 days ago
Bengaluru, India Biocon Biologics Full timeJob Description The Idea candidate for the Drug Safety Specialist - Safety Surveillance and Risk Management Role's responsibility is as follows :Supports the signal management process (i.e set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports etc) for the assigned...
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Drug Safety Specialist Surveillance
7 days ago
Bengaluru, India Biocon Biologics Full timeJob Description The Idea candidate for the Drug Safety Specialist - Safety Surveillance and Risk Management Role's responsibility is as follows :Supports the signal management process (i.e set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports etc) for the assigned...
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Bengaluru, India Biocon Biologics Full timeWe are seeking a drug safety specialist in Safety Surveillance and Risk Management who is responsible for safety signal management activities, risk management plans & overseeing aggregate report scheduling, preparation, and submission, responding to safety questions from internal and external stakeholders, reviewing the medical and scientific literature for...
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Bengaluru, India Biocon Biologics Full timeWe are seeking a drug safety specialist in Safety Surveillance and Risk Management who is responsible for safety signal management activities, risk management plans & overseeing aggregate report scheduling, preparation, and submission, responding to safety questions from internal and external stakeholders, reviewing the medical and scientific literature for...
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Bengaluru, India Biocon Biologics Full timeWe are seeking a drug safety specialist in Safety Surveillance and Risk Management who is responsible for safety signal management activities, risk management plans & overseeing aggregate report scheduling, preparation, and submission, responding to safety questions from internal and external stakeholders, reviewing the medical and scientific literature for...
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Drug Safety Expert I
6 days 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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Safety Surveillance Advisor I
2 weeks ago
Bengaluru, India Novo Nordisk AS Full timeDepartment: Global Safety - Global Business Services (GS-GBS).Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives?...
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Safety Surveillance Advisor I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment : Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career...
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Safety Surveillance Advisor I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment: Global Safety - Global Business Services (GS-GBS).Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives?...
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Safety Surveillance Adviser I
2 months ago
Bengaluru, Karnataka, India Novo Nordisk Full timeSafety Surveillance Adviser I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department** : Global Safety - Global Business Services (GS-GBS).- **The Position** - As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the...
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Safety Surveillance Adviser I
3 weeks ago
Bengaluru, Karnataka, India Novo Nordisk Full timeSafety Surveillance Adviser I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department** : Global Safety Global Business Service (GS-GBS).- **The Position** - As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the...
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Safety Surveillance Adviser I
3 weeks ago
Bengaluru, Karnataka, India Novo Nordisk Full timeSafety Surveillance Adviser I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department** : Global Safety Global Business Service (GS-GBS).- **The Position** - As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the...
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Safety Surveillance Advisor I
6 days ago
Bengaluru, Karnataka, India Novo Nordisk Full timeSafety Surveillance Advisor I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department** : Global Safety - Global Business Services (GS-GBS).- **The Position** - As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the...
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Safety Surveillance Adviser I
2 months ago
Bengaluru, India Novo Nordisk Full time**Department** : Global Safety Global Business Service (GS-GBS). **The Position** As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN) products during...
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Safety Surveillance Advisor I
1 month ago
Bengaluru, India Novo Nordisk AS Full timeDepartment : Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career...
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Safety Surveillance Advisor I
3 weeks ago
Bengaluru, India Novo Nordisk AS Full timeDepartment : Global Safety - Global Business Services (GS-GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career...
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Senior Drug Safety Associate
1 week ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment : Global Safety GBS (GS - GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might...
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Senior Drug Safety Associate
2 weeks ago
Bengaluru, India Novo Nordisk AS Full timeDepartment : Global Safety GBS (GS - GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might...
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Safety Surveillance Adviser I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk Full timeSafety Surveillance Adviser ICategory:Reg Affairs & Safety PharmacovigilanceLocation:Bangalore, Karnataka, INDepartment : Global Safety Global Business Service (GS-GBS).-The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed...
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Safety Surveillance Adviser I
1 week ago
Bengaluru, Karnataka, India Novo Nordisk Full timeSafety Surveillance Adviser ICategory:Reg Affairs & Safety PharmacovigilanceLocation:Bangalore, Karnataka, INDepartment : Global Safety - Global Business Services (GS-GBS).-The Position As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed...
