Senior Specialist, Pharmacovigilance, Epidemiology
7 days ago
Job Description 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 risk-benefit balance. - SOP services/writing and review of SOPs, WIs and related documents and training material in the area of pharmacovigilance for clients (including implementation and training. - Development of customer-specific solutions and processes in cooperation with clients. - Build, develop and maintain working relationships with clients. - Ensure client satisfaction and compliance with legal and regulatory requirements. - Representation of the company and the team with clients, authorities and professional institutions. - Inform the Head of the Pharmacovigilance Team/Service Line Lead regularly about systematic problems that could jeopardize an appropriate coordination of tasks and to present solutions. - Management of parts of a project or the complete project. - Fulfilling highly complex, sophisticated tasks within the area of pharmacovigilance. - Trigger a non-conformity when any performance deviation from the target KPI (Key Performance Indicator) is detected, issue evaluation and root cause analysis, assign corrective actions with a due date to the most appropriate employee, ensure that all agreed actions are completed by the due date. - Communicate proactively with clients about the status of the project and provide solutions to address process deviations, quality issues and inefficiencies. - Development of processes and/or tools within the area of pharmacovigilance in collaboration with the Head of the team and the Head of the Pharmacovigilance Department. - - Design and prepare Standard Operational Procedures, Working instructions and Client Specifications for Pharmacovigilance processes, ongoing revisions and implementation of updates. Contribute to achievement of departmental goals, Identify and discuss out-of-scope activities that affect project invoicing. - Client audits (preparation of the audit, defend it, review the audit report and follow action plan). Contribute to resource needs and resource allocation to ensure compliance, identification and implementation of process efficiency needs. - .Minimum 4 years of experience in relevant field. - Experience in writing and reviewing PBRER, PSUR, RMP, PADER and ACO - Experience in Preparation of responses to PRAC, other authority requests - Experience in writing and review SOP, preparing training material - Build update and maintain working relationships with client
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Noida, India PharmaLex Full timeOur 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...
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Noida, Uttar Pradesh, India PharmaLex Full time ₹ 12,00,000 - ₹ 36,00,000 per yearOur 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...
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Specialist, Pharmacovigilance, Epidemiology
2 weeks ago
Noida, Uttar Pradesh, India PharmaLex Full time ₹ 5,00,000 - ₹ 12,00,000 per yearOur 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...
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Specialist, Pharmacovigilance, Epidemiology
3 weeks ago
Noida, India PharmaLex Full timeOur 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...
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Noida, India World Courier Full timeJob Description - 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, concomitant medications, lab data,...
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Specialist, Pharmacovigilance, Epidemiology
7 days ago
Noida, India World Courier Full timeJob Description - 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 concerned, including reporting timelines - Preparation of standard reporting forms (eg, CIOMS I / MedWatch Forms and XML files) -...
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Lead Business Analyst
3 weeks ago
Noida, Uttar Pradesh, India Wipro Full timeWe use cookies to offer you the best possible website experience Your cookie preferences will be stored in your browser s local storage This includes cookies necessary for the website s operation Additionally you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve website s performance as well as...
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Gurugram, New Delhi, Noida, India Resolve Medicode Full time ₹ 15,00,000 - ₹ 25,00,000 per yearClinical trials is a crucial field in the pharmaceutical industry focused on drug safety. Professionals in this area monitor, assess, and prevent adverse drug reactions to protect public health.Qualification & Specifications :MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T,...
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Senior Specialist Pharmacovigilance
2 weeks ago
Noida, Uttar Pradesh, India PharmaLex Full time ₹ 12,00,000 - ₹ 36,00,000 per yearOur 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...
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Data Reporting Lead
2 days ago
Noida, Uttar Pradesh, India YD Talent Solutions Full time ₹ 20,00,000 - ₹ 25,00,000 per yearSenior Data Specialist - Reporting - Pharmacovigilance (PV)Noida, IndiaOnsiteCompany Overview:Our client is a leading provider of Pharmacovigilance (PV) Technology Solutions. They bring together Life sciences domain expertise, third party system knowledge and advanced technology to develop well-defined solutions, which address challenges across PV...
