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2.0 - 6.0 years
2 - 6 Lacs
hyderabad
Work from Office
Company Description MakroCare | A MakroGroup Company | www.MakroCare.com MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion. MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations) Experience & Eligibility Criteria: 2-6 Years of experience with literature searches/ electronic literature databases and Clinical Evaluation Report ...
Posted 3 weeks ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
As a Safety Specialist II at our company, your role will involve the following responsibilities: - Authoring and reviewing various Aggregate Safety Reports such as DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports as required by the project. - Reviewing aggregate safety data, generating line listings (LL) and summary tabulations (ST), and incorporating them into the appropriate templates. - Analyzing safety and regulatory data provided by clients to prepare comprehensive Aggregate Reports. - Conducting literature screening to include significant safety articles in the respective sections of aggregate reports. - Compiling benefit-risk evaluation sections provided by medical reviewe...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
haryana
On-site
As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, you will play a crucial role in ensuring the safety of patients by handling and processing Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements. Your responsibilities will include: - Entering information into PVG quality and tracking systems for ICSRs receipt and tracking - Assisting in processing ICSRs according to SOPs and safety plans - Triaging ICSRs, evaluating data for completeness and accuracy - Entering data into safety database, coding events, medical history, medications, and tests - Compiling complete narrative summaries and identifying information to be queried - Generating exp...
Posted 2 months ago
0.0 - 4.0 years
0 Lacs
haryana
On-site
As a Safety & PV Trainee at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. By entering information into PVG quality and tracking systems, processing ICSRs, and maintaining safety tracking, you will contribute to the accurate and timely reporting of safety data. Your responsibilities will include: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assisting in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triaging ICSRs, evaluating ICSR data for complet...
Posted 2 months ago
2.0 - 6.0 years
0 Lacs
pune, maharashtra
On-site
Role Overview: As a Safety & PV Specialist I-Japanese at Syneos Health in Pune Office, your primary responsibility will be to ensure accurate and timely processing of Individual Case Safety Reports (ICSRs) in compliance with Standard Operating Procedures (SOPs) and regulatory requirements. You will play a crucial role in maintaining safety tracking, performing data entry into safety databases, coding events and medical history, and compiling narrative summaries. Additionally, you will be involved in the validation and submission of xEVMPD product records, management of duplicate ICSRs, and activities related to SPOR / IDMP. Key Responsibilities: - Ensure accurate and timely processing of Ind...
Posted 2 months ago
2.0 - 6.0 years
2 - 6 Lacs
hyderabad
Work from Office
Experience & Eligibility Criteria: 2-6 Years of experience with literature searches/ electronic literature databases and Clinical Evaluation Report (CERs) documents writing Education in any UG/PG in Life Science (1st Pref B/M Pharmacy). Job Description: Scientific Analyst (Scientific Literature search) Design of literature searches to be implemented in electronic literature databases Conducting systematic/targeted/structured literature reviews Developing and performing database searches and writing protocols and reports for literature reviews Identifying relevant evidence for research questions (Literature Screening) Summarizing literature review findings in a report Extracting, analyzing, a...
Posted 2 months ago
2.0 - 6.0 years
2 - 6 Lacs
Hyderabad
Work from Office
Experience & Eligibility Criteria: 2-6 Years of experience with literature searches/ electronic literature databases and Clinical Evaluation Report (CERs) documents writing Education in any UG/PG in Life Science (1st Pref B/M Pharmacy). Job Description: Scientific Analyst (Scientific Literature search) Design of literature searches to be implemented in electronic literature databases Conducting systematic/targeted/structured literature reviews Developing and performing database searches and writing protocols and reports for literature reviews Identifying relevant evidence for research questions (Literature Screening) Summarizing literature review findings in a report Extracting, analyzing, a...
Posted 5 months ago
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