2937 Pharmacovigilance Jobs - Page 34

Description Safety & PV Ops Specialist I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, ...

Description Safety & PV Ops Specialist I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, ...

Job Overview Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual. Summary Of Responsibilities Assume a...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Responsible for the planning, execution and documentation of CSV according to internal procedures and external requirements (e.g. GxP, GAMP 5, 21 CFR Part 11) Working with all technology teams by reviewing work carried out when necessary to identify compliance issues and improvements by providing advice or ...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Conduct Medical Review and assessment of ICSR’s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, rev...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Conduct Medical Review and assessment of ICSR’s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, rev...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details To lead a team of Drug Safety Physicians working on ICSRs Projects. Conduct initial assessment and Medical Review of ICSR’s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concom...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Preparation of responses to PRAC assessment reports and other Authority requests (e.g., referrals, etc). Performing signal detection and signal analysis of safety data, provide the appropriate expert advice as well as assisting in communication with regulatory agencies when the new data has an effect on the...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases. Responsible for quality management, workload management, compliance management and document management for the assigned PV projects Evaluation of the need for e...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Performing triage and review for initial validity assessment of cases including spontaneous, health authority, Clinical Trial and literature cases. Data entry into PV database Initial ICSR assessment, if applicable Evaluation of the need for expedited reporting to Health Authorities / partners of a client c...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Job Summary: Responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of Literature Screening. Key Responsibilities Responsible for quality management, workload management, compliance management and document management for the assigned PV p...

Responsible for providing scientific and medical support for pharma products, engaging with doctors and internal teams, and ensuring ethical and evidence-based communication across all channels Scientific knowledge (pharma/medical background) Medical communication (verbal & written) KOL interaction Clinical research understanding Regulatory & compliance awareness Medical content review Presentation & training skills Team coordination Analytical thinking Problem-solving ability

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving...

Skill required: Clinical Data Services - Clinical eTMF Management Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving...

Skill required: Clinical Data Services - Clinical eTMF Management Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving...

Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s). 3) Adapts global scientific response documents for assigned countries. 4) Develops responses to escalated inquiries for assigned countries. 5) Develops contributions to US NDA Annual Reports. 6) Contributes to US compendia reviews. 7) Ability to execute the MI projects once they are conceptualized with guidance from experienced team members or mangers 8) Demonstrates resolve and urgency to ac...

JD: Title: Safety & Pharmacovigilance-I Location: Hybrid-Gurugram Experience: 1-4 yrs Skillset: 1)Experience in ICSR case processing. Spontaneous / CT/ Literature case processing experience will also be considered. Good understanding on Medical Knowledge / Terminology . 2)Databases/Tool: Argus /Aris-G / LSMV 3)Good communication. Interested one kindly apply thorugh below link. https://www.syneoshealth.com/careers/jobs/16631872-safety-and-pv-specialist-i or Navigate to Syneos Careers: Job ID: 25100771 Regards, Naveen.R

Manager, Medical Content Review & Regulatory Compliance Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed and detail-oriented pharmacist or physician, with experience in medical review from a healthcare compliance perspective, then we want to hear from you. Join us to help improve peoples' lives and make healthcare better for everyone! Why Pharmanovia? Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted me...

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining ...

Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues. Ensure regulatory compliance for all maintained innovative, biosimilar and generic EU procedures (MRP, DCP, CP) regarding labeling. How you ll spend your day Labeling Responsible for creating and updating compliant English product information for EU procedures. Strategic planning and implementation of changes affecting multiple product information documents. Dete...

Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s). Adapts global scientific response documents for assigned countries. Develops responses to escalated inquiries for assigned countries. Develops contributions to US NDA Annual Reports. Contributes to US compendia reviews. Ability to execute the MI projects once they are conceptualized with guidance from experienced team members or mangers Demonstrates resolve and urgency to accomplish tasks under ...

Work Experience (Total number of years/ experience/ background or equivalent) : Total experience (in years): 15 Experience in current role (in years): 6.5 Years Work Background: Formulation Development, Technology Transfer, Root Cause Investigations, Project Management Primary Job Function To drive technology transfer for Third party manufacturing, Loan license projects, Abbott s own manufacturing plants. To support Abbott site MS&T team as per requirements. To support Alternate supplier qualification of raw materials & API. To comply with the regulatory, quality, statutory, EHS and Pharmacovigilance requirements. Core Job Responsibilities - To perform effective gap analysis between sender &...

1.Scientific/Medical Knowledge PV Expertise Practical experience in and basic and emerging additional knowledge of pharmacovigilance and safety surveillance. Able to work more independently with limited supervision as required. May be assigned as responsible for safety monitoring and evaluation of assigned GSK products. Performs routine PV activities to include the review of ICSRs and monitoring and evaluation of assigned GSK products. Review literature articles for Safety topics of interest and detection of safety signals. Basic labelling knowledge and may participate in labelling team activities. Draft Aggregate Report safety sections and support addressing response to queries (RTQs). Perf...

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case clos...

Roles & Responsibilities 1. To support and execute formulation development of mAbs 2. Conducting stability studies as per ICH guidelines. 3. Acquisition, recording, analysis and compilation of data in prescribed formats. 4. Responsible for maintenance and documentation of the developmental work carried out. 5. Supporting procurement/installation of appropriate equipment’s and consumables required for work, whenever applicable. 6. Capturing and compilation of the data generated contemporaneously in eLN (electronic Lab Notebook) and getting the same verified by the manager of the team regularly. 7. Ensuring proper usage and maintenance and calibration of equipment: entering the usage in log bo...