1738 Pharmacovigilance Jobs - Page 35

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Contracting deliverables Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials Work with partners to develop and oversee the global site budget process Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline Collaboratio n Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives Compliance with Parexel standards Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Balance of general business, compliance, finance, legal, and drug development experience Precise communications and presentation skills Ability to plan, identify and mitigate risks to site contacting timelines Ability to lead by influence rather than positional power to accomplish critical deliverables Success in working in a highly matrix based organization Fluency in written and spoken English is required Knowledge and Experience: Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities Knowledge of the principles, concepts and theories in applicable business discipline Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred Education : Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing

Knowledge and Experience: Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience Master’s degree in a science, technology or industry related discipline, preferred

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy Years of Experience: 0 to 1 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 clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. Basic knowledge in Medical Terminology Basic knowledge about Pharmaceuticals & Clinical Research Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English - Advanced About Accenture 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 worlds 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 clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years About Accenture 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 worlds 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 clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE,BTech,MCA

Skill required: Marketing Operations - Medical Affairs Designation: Copywriting Senior Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years About Accenture 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 worlds 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 clients in more than 120 countries. Visit us at www.accenture.com What would you do Able to develop content and perform medical review for various clinical and regulatory documents following regulatory guidelines.Use scientific expertise to develop high-quality medical/scientific content outlines and guide the team in content development for assigned modules/projects in line with client expectations.Experience in writing white papers, manuscripts, point of view, etc.Write scientific content for projects if the nature of the project is extremely complex and it requires expertise or based on business need.Communicate the clinical data in a clear and concise manner.Follow department best practices for processes, communication, project management, documentation, and technical requirements.Converts relevant data and information into a form that meets regional regulatory requirements.Understands and complies with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs to comply with regulatory requirements.Completes assignments independently or for more complex documents, under the guidance of a mentor.Ensure compliance with client and Accenture internal SOPs for all materials.Collaborate with technology and creative teams to develop innovative digital solutions.Participate in client pitches and business development meetings.Train and mentor scientific writers, contributing to skill development.Ensure quality delivery and client engagement for organic growth.In Medical Affairs, you will have to design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy, regulatory review and approval of pharmaceutical drugs and perform publishing and quality control tasks on submission components. What are we looking for Clinical & Regulatory WritingLife Sciences Regulatory OperationsMedical AffairsStrong analytical skillsProblem-solving skillsResults orientationWritten and verbal communicationExperience in research and developmentAbility to define medical communication strategy and development of new content for communication.Medical ReviewLife Sciences Regulatory AffairsExperience from the pharmaceutical/life sciences industryExperience in creating medical communications content for medical affairs/promo medical communication and education, preferably within an agency or pharma environment. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years About Accenture 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 worlds 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 clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for Clinical Database ProgrammingClinical Data ManagementOracle Procedural Language Extensions to SQL (PLSQL)Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamSAS ClinicalStructured Query Language (SQL) Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years About Accenture 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 worlds 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 clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification BE,BTech,MCA

Help us bring cutting-edge medical treatments to life! Become a key player in clinical research and accelerate advancements in healthcare. Opportunities We offer two paths into the exciting world of clinical research: Internship: Get a hands-on introduction to clinical trials through a time-bound internship program. Ideal for students or recent graduates eager to experience the field. Fresher-Level Position: Launch your career as a Clinical Research Coordinator! This position offers ongoing employment for those committed to this exciting field. Regardless of path, you'll get to: Manage the flow of clinical trials: Oversee study logistics, participant documentation, and ensure the study progresses smoothly. Be a meticulous record-keeper: Collect and safeguard essential research data with the highest industry standards. Champion safety and ethics: Protect patient rights and ensure all research practices are ethical and compliant. Work within a team of like-minded professionals: Collaborate with investigators, healthcare providers, and fellow research enthusiasts. Qualifications Internship: Enrolled in or a recent graduate of a degree program in life sciences, health sciences, nursing, or a related field. Fresher-Level Position: Recent graduate with a degree in life sciences, health sciences, nursing, or a related field. For both: Passion for research, detail-orientation, strong organizational skills, clear communication, and willingness to learn. What We Offer Hands-on experience: Jumpstart your career or get real-world training. Training and mentorship: Get guidance from experienced researchers in the field. Professional development: Access resources or company-sponsored coursework to enhance your potential. Competitive compensation: Interns receive a stipend; fresher-level position offers salary and benefits. A role at the forefront of medical innovation: Shape the future of healthcare.

We are seeking a highly motivated and detail-oriented recent graduate to join our Drug Safety team as an Entry-Level Drug Safety Associate. This is an excellent opportunity to launch your career in the pharmaceutical industry and contribute to the safety surveillance of our products. You will gain practical experience in various aspects of drug safety, including adverse event processing, data entry, and safety reporting. This role is perfect for individuals with a strong interest in drug safety and a desire to learn and grow in a fast-paced environment. Responsibilities: Adverse Event Case Processing: Receive, triage, and accurately enter adverse event reports into the drug safety database. Ensure timely and accurate data entry in compliance with company Standard Operating Procedures (SOPs) and regulatory guidelines. Assist in the follow-up of adverse event reports to obtain complete and accurate information. Perform quality control checks on case data to ensure accuracy and consistency. Data Management and Safety Reporting: Assist in the preparation of safety reports and data summaries. Maintain accurate and organized drug safety records. Assist in the tracking and monitoring of adverse event trends. Learn to identify and escalate potential safety signals. Regulatory Compliance: Develop a basic understanding of global drug safety regulations and guidelines (e.g., ICH guidelines). Adhere to company SOPs and regulatory requirements. Assist in the preparation of regulatory submissions. General Support: Assist in the maintenance of drug safety databases and systems. Participate in team meetings and training sessions. Support senior drug safety staff as needed. Perform other duties as assigned. Qualifications: Bachelor's degree in Pharmacy, Pharmacology, Life Sciences, Nursing, or a related healthcare field. Strong interest in drug safety and pharmacovigilance. Excellent attention to detail and accuracy. Strong organizational and time-management skills. Ability to work independently and collaboratively within a team. Good communication and interpersonal skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Must be a recent graduate. Preferred Qualifications (but not required): Basic understanding of medical terminology. Familiarity with drug safety databases or systems. Coursework related to pharmacology or drug safety.

Note: This role would involve Rotational Shifts (Morning and Nights) Basic roles: Patient care Maintain compliance Clinically sound Assist the surgeon/Consultant Roles and Responsibilities Basic roles: Patient care Maintain compliance Clinically sound Assist the surgeons

PMS College of Dental Sciences & Research is looking for Asst Proffesor - Pharmacology to join our dynamic team and embark on a rewarding career journey Develop and deliver high-quality lectures and instructional materials. Conduct research and publish findings in academic journals. Advise and mentor students on academic and career matters. Participate in academic committees and contribute to curriculum development. Stay current with developments in the field and incorporate them into teaching.

Lilavati Medical Center is looking for Clinical Associate - Radiology to join our dynamic team and embark on a rewarding career journey Perform and interpret diagnostic imaging procedures, including X-rays, MRI, CT scans, and ultrasounds. Provide expert consultation to other physicians regarding radiologic findings. Ensure high-quality imaging and patient safety. Stay updated with advancements in radiology technology and techniques. Participate in multidisciplinary team meetings to discuss patient care plans. Conduct research and contribute to radiology publications. MD/DNB (Radiology) with post graduate experience from a reputed Hospital.

Job Title: Business Analyst Department: Product Management Location: Bangalore/Hyderabad Experience: 3-8 years About Datafoundry: Datafoundry is an AI first company with solutions to accelerate digital transformation. As part of our initial focus on the Life Sciences industry, we have built AI-automation products in the Safety Vigilance domain. Datafoundry has multiple AI/ML algorithms that can solve digitalization problems across industry sectors such as Health Care, Utilities, Aerospace and Defence, Manufacturing, Banking and Financial sectors. Job Description: At Datafoundry, we are building disruptively innovative products at the intersection of Life Sciences and AI. Our products help businesses automate key business processes and leverage the insights from digital transformation. You will be working in a fast paced, agile, inclusive and collaborative culture to bring products and services to the market for better health outcomes. The role of a Business Analyst/Product Owner at Datafoundry is critical to the success of our customers. The BA/PO will be part of the Product Management team and work closely with the Project Manager, Product Manager, Engineering and Machine Learning teams, SQA and Customers. The main tasks will be to perform detailed requirements analysis, ensuring traceability between requirements, design specs and testcases, documenting processes needed, and coordinating user acceptance testing. One should have natural, analytical thinking skills, able to do research on domain-specific areas (E.g.: Pharmacovigilance, Clinical Trial Management, Literature Reviews etc.), engage in collaborative working with technical teams, and should enjoy explaining difficult concepts to business (non-technical users). Roles and Responsibilities: Researching and evaluating Pharma/CRO/Medical Devices/Cosmetics business processes, anticipating requirements, uncovering areas for improvement, and developing and implementing solutions. Staying up to date on the latest process and technology advancements to automate and modernize systems in the Life Sciences and Health Care domain Conduct meetings and presentations to share ideas and findings. Performing requirements analysis. Documenting and communicating the results of your efforts. Effectively communicating your insights and plans to cross- functional team members and management. Gathering critical information from meetings with various stakeholders and producing useful reports. Working closely with clients, engineers, and managerial staff. Ensuring solutions meet business needs and requirements. Driving/Performing user acceptance testing. Serving as a liaison between stakeholders and users. Managing competing resources and priorities. Monitoring deliverables and ensuring the timely completion of projects. Requirements and Skills: A bachelor’s degree in business or technology or related field or an MBA A minimum of 3 years of experience in business analysis or relevant field Experience in Life Sciences or Health Care domain (Pharma, Biotech, Cosmetics, Medical Devices, Health Care etc.) Experience in Agile SDLC approaches and Project Management Exceptional analytical and conceptual thinking skills. Excellent documentation skills Experience creating detailed reports and giving presentations. Proficiency in Microsoft applications Knowledge of JIRA or similar software Experience/exposure to Cloud Computing Platforms –AWS, Azure, GCP etc. A track record of following through on commitments. Excellent planning, organizational, and time management skills. Good understanding of regulatory compliance in the Life Sciences domain (GxPs, CSV and Part 11) Ability to create flow charts, data flow diagrams, state diagrams to explain and document the requirements/a process. Join our team at Datafoundry to be part of an exciting journey as we revolutionize the way organizations leverage data to gain a competitive advantage. We offer attractive compensation and bonus package, a flexible remote work environment, and ample opportunities for professional growth.

Job Title: Director – Clinical Research Location: Greater Noida Experience Required: 5–10 Years in Clinical Research Educational Qualification: Ph.D., MD, or MPH (or equivalent) in a relevant scientific discipline (e.g., Biology, Medicine, Pharmacy) Budgeted CTC: Upto ₹36 LPA Employment Type: Full-Time | Onsite About the University: Our Client is a NAAC A+ accredited, multidisciplinary university in Greater Noida that fosters global learning, cutting-edge research, and innovation. With over 20,000 students from 85+ countries, the university is one of India’s leading education providers with a focus on holistic and interdisciplinary education. Position Overview: We are seeking a highly qualified and experienced Director – Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology , and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. Develop and implement clinical trial strategies, including protocol design, study planning, and risk mitigation. Provide mentorship and guidance to clinical research teams and collaborators. Clinical Trial Management: Oversee the planning, initiation, execution, and close-out of clinical trials. Ensure compliance with FDA regulations, ICH GCP guidelines, and applicable local regulations. Coordinate with CROs, investigators, and site staff for study implementation and monitoring. Regulatory & Compliance: Prepare and review clinical protocols, Investigator Brochures (IBs), informed consent forms, and regulatory submissions. Ensure ethical and regulatory compliance throughout all research activities. Data Analysis & Reporting: Collaborate with biostatisticians and data managers to analyze clinical data. Interpret study results and oversee preparation of study reports, publications, and regulatory documentation. Stakeholder Engagement: Liaise with cross-functional departments including medical affairs, pharmacovigilance, and R&D. Represent the organization in scientific meetings, regulatory discussions, and industry forums. Desired Candidate Profile: Educational Background: Ph.D., MD, or MPH in a relevant scientific field such as biology, medicine, pharmacology, pharmacy, or public health. Experience: Minimum 5–10 years of progressive experience in clinical research, with a strong track record in managing trials from concept to completion. Prior experience in oncology research is highly preferred. Experience working with global clinical trial regulations, particularly FDA and ICH GCP. Skills & Knowledge: Excellent knowledge of clinical trial design, regulatory pathways, and protocol development. Proficiency in statistical software (e.g., SAS, SPSS, R), data management tools (e.g., Medidata, Oracle Clinical), and relevant e-clinical systems. Strong communication, leadership, and problem-solving skills. Ability to work collaboratively in a cross-functional environment. Key Competencies: Strategic thinking and project leadership Clinical compliance and operational excellence Scientific acumen and data interpretation Team mentoring and stakeholder management Attention to ethical and quality standards Application Process: Interested candidates may send their updated CV and a brief statement of clinical leadership experience to: [connect@coral-ridge.com] | Subject Line: Application for Director – Clinical Research Shortlisted candidates will be contacted for an in-depth discussion and final round of interaction. Job Types: Full-time, Permanent Pay: ₹3,000,000.00 - ₹4,000,000.00 per year

Company Description Clinformatiq is a leading Clinical Research and Healthcare IT training institute dedicated to bridging the gap between academics and industry. We provide comprehensive training in Clinical Research, Pharmacovigilance, CDM, Regulatory Affairs, Medical Coding, and Clinical SAS. Our programs are designed to prepare graduates for real-world roles through hands-on learning and industry tie-ups. Our mission is to empower students with the right skills and connect them to top career opportunities in the life sciences sector. Role Description This is a full-time, on-site role located in Guntur for a Business Development Associate. The Business Development Associate will be responsible for generating leads, conducting market research, and preparing and delivering presentations. In addition, the role will involve maintaining effective communication with potential clients and stakeholders to drive business growth. Qualifications Lead Generation and Market Research skills Presentation Skills and ability to create and deliver Presentations Strong Communication skills Excellent interpersonal and organizational skills Ability to work independently and as part of a team Experience in the healthcare or education sector is a plus Bachelor's degree in Business, Marketing, or related field Requirements: Male Candidates Only

Location Bengaluru, Karnataka, India Job ID R-228704 Date posted 22/06/2025 Job Title: Local Case Intake Advisor (Thai Language) - Global Business Services Career Level - C Introduction to role Are you passionate about patient safety and compliance? As a Local Case Intake Advisor, you will manage the intake, processing, and reporting of individual case safety reports (ICSRs) at the local level. You will support specific local Marketing Companies to ensure compliance with AstraZeneca (AZ) and relevant national regulatory requirements, serving as the primary liaison between those Marketing Companies and GBS-PS. This role requires fluency in English and involves working under the guidance of Case Intake Team Managers to deliver routine activities independently, resolve moderate scope problems, and conduct activities consistent with things we value and compliance standards. Accountabilities Support provision of pharmacovigilance activities including local processes, procedures, and systems for collection, reporting, and tracking of Adverse Events (AEs). Review, assess, and process safety data from various sources, distributing reports to internal and external third parties. Identify Product Quality Complaint (PQC) and Product Security complaints, collecting necessary information for AE complaint reporting. Provide prompt support for regulatory authority queries related to the Patient Safety function. Implement Corrective and Preventative Actions in the event of local non-compliance. Ensure reconciliations for the accuracy of pharmacovigilance data transferred and received. Periodically screen regulatory authority databases for adverse events. Perform literature search and related activities for MC product portfolio if required. Undertake manual follow-up where required, disseminating clear and accurate information based on approved call scripts. Maintain filing and archiving practices of patient safety documents. Actively contribute to maintaining Good Pharmacovigilance Practice and being audit and inspection ready. Support external service providers to meet company and local regulatory PV requirements. Assist the local PS team in audits or regulatory authority inspections. Complete all required patient safety trainings and obtain access to relevant systems. Maintain current knowledge of relevant country regulatory authority regulations, global and local procedural documents, marketed status of products, and conditions relating to product safety. Essential Skills/Experience Degree Qualified – Pharmacy/ Medical/ Science Language skill - Thai Pharmacovigilance knowledge excellence Good Pharmacovigilance Practice Knowledge of health authority regulations Cross-functional collaborative approach Effective and lateral thinking Problem solving Vendor management Excellent attention to detail Excellent written and verbal communication skills Desirable Skills/Experience Influencing and Conflict Resolution skills Medical knowledge in company Therapeutic Areas Project management Successful participation in above-market projects Audit & Inspection experience When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, our work has a direct impact on patients, transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate, take ownership, and explore new solutions in a dynamic environment that encourages lifelong learning. Ready to make a difference? Apply now to join our team! Date Posted 23-Jun-2025 Closing Date AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. ]]>

Role- Medical Reviewer(MCI Cert.) MBBS/MD Graduates with 1 yr to 8 yrs of Clinical/Non Clinical Exp in Clinical Trials, PV, ICSR, SUSAR 5 Days WFO| 2 RWO| General Shift SALARY UP-TO 18LPA CALL- RUKHSAR- 9899875055 SUHANI- 9911988552 Divya- 9911988842

Safety Physician - ICSR 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, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Performs medical review of adverse events reported for investigational and marketed products Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS. Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information Identifies, communicates and effectively manages potential safety issues Interacts with client s safety/medical personnel as appropriate Stays abreast of clinical and drug development information relevant to contracted programs Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs) Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education Assists as a mentor and trainer for other internal safety staff including case processing staff Responsible for performing activities that are in compliance with applicable Corporate and D Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines Performing other duties as assigned by management. Qualifications The incumbent should possess M.D., MBBS, D.O. Completed an accredited residency; Minimum of one to two (1 to 2) years of experience in clinical practice Minimum of one year of experience in the pharmaceutical, biotechnology, or device industry working in pharmacovigilance/epidemiology preferred Knowledge of global pharmacovigilance regulations and processes Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), safety databases, and internet. Excellent verbal and written communication skills (proficient in English) as well as in the language required for case processing Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform and influence Ability to travel as necessary (up to 10%) Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Manager, Safety & PV (Japanese Language Professional) 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, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization. Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management. Manages projects where Safety and Pharmacovigilance are the primary services. o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. o Works with Finance to ensure appropriate customer invoicing, where required. o Approves project time cards and invoicing. o Provides sponsors with scheduled project updates and reports. o Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues. Participates in the management of the Safetyand Pharmacovigilance department with the following actions: o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. o Works with Business Development to actively solicit new business, as needed. o Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings. Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project. Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process. Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members Managing resourcings needs/issues and escalating to senior management as necessary. Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions. Performs other work related duties as assigned. Minimal travel may be required. Qualifications - Must be a N3 or above certified (JLPT) Japanese Language professional - BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience Progressive responsibility with demonstrated leadership skills and project management Clinical Research Organization (CRO) experience with therapeutic specialties preferred Working knowledge of financial budgets and various financial analysis tools preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills Ability to establish effective relationships with clients as well as team members Ability to be flexible, adapt to change, work independently, as well as part of a teamin a matrix environment Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

We are seeking life science graduates interested in building a long-term career in the Clinical Research domain. This opportunity is part of our industry-integrated Clinical Research Training Program designed to prepare candidates for roles such as CRA, CRC, and Drug Safety Associate . Role Responsibilities (Post-Training Readiness) Understand and support clinical trial processes, site coordination, and documentation Learn Good Clinical Practices (GCP), ICH guidelines, and regulatory frameworks Monitor data collection and compliance Collaborate with CROs, hospitals, and research organizations (Post-placement) Eligibility Criteria Education: B.Sc, B.Pharm, M.Sc, BDS, BPT, BHMS, BAMS, Nursing, MBBS Background: Life Sciences or Healthcare domain Experience: 02 years Location: Open to all Indian cities (program delivered online & offline) Must have interest in Clinical Trials, Research, Pharmacovigilance, or Regulatory Affairs

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 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 clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? Clinical Database Programming Clinical Data Management Oracle Procedural Language Extensions to SQL (PLSQL) Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to work well in a team SAS Clinical Structured Query Language (SQL) Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts BE,BTech,MCA

Perform case intake and data entry into safety databases (e.g., Argus, ArisG). Assist in triaging and prioritizing cases based on seriousness and timelines. Perform quality checks to ensure accuracy and completeness of information. Collect and process adverse event (AE) reports from healthcare professionals, patients, and regulatory authorities Support Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Draft case narratives and perform medical coding (MedDRA). Job Type: Full-time Pay: ₹305,702.54 - ₹565,749.57 per year Benefits: Cell phone reimbursement Health insurance Paid sick time Provident Fund Work Location: In person

Vasta Bio-Informatics Private LimitedMAHARASHTRA Posted On 20 Jun 2025 End Date 31 Jul 2025 Required Experience 1 - 3 Years Basic Section No. Of Openings 2 Grade C1B Designation Clinical Research Associate Closing Date 31 Jul 2025 Organisational Country IN State MAHARASHTRA City NAVI MUMBAI Location Navi Mumbai-I Skills Skill PHARMACOVIGILANCE CLINICAL RESEARCH MEDICAL WRITING ONCOLOGY CLINICAL DEVELOPMENT CRO GCP EDC CLINICAL DATA MANAGEMENT ICH-GCP Education Qualification No data available CERTIFICATION No data available Job Description Job Title: Clinical Research Associate Department: Delivery Job Location: Navi Mumbai Reporting To: Lead Job Duties / Responsibilities: Project and Operations Management- Responsible for the management of designated clinical trials, preparation of trial related documentation per protocol and Case report forms (CRF). Ensure completeness and submission of data into the data collection form (e.g., electronic CRFs, cancer research database (CRDB), PC-based systems, remote data entry) as per protocol requirements and time lines. Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion and in compliance with ICH-GCP guidelines. Ensure the conduct of the trial is in compliance with the currently approved protocol/amendment. To significantly improve quality assurance and consistency in electronic data capturing and data. Participate in global conference calls and meetings to review progress of ongoing clinical trials. Proficient in the knowledge of protocol monitoring activities. Verify that the investigator followed the approved protocol and all GCP procedures. Communicate any observations to the sponsor i.e. deviations/violations to protocol, safety alerts, quality issues, etc. that may affect the quality of the protocol. Complete regulatory requirements, as applicable. Education and Experience: Bachelors/ Masters Degree with minimum 1 year experience in Clinical Trials Management/Protocols or 0-6 months of experience in Clinical Trials along with certification in Clinical Trials / Research. Knowledge of Oncology Specific terminology preferred. Knowledge of EDCs such as Medidata RAVE, Oracle, Inform, etc. strongly preferred. Experience with Industrial protocols and monitoring visits strongly preferred. Hands-on with computer skills Good communication skills – written and verbal Ability to multitask, work under pressure and meet deadlines required

Job Overview Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports to Regulatory Authorities, Investigative sites, and Ethical committees following applicable Regulations and Standard Operating Procedures (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 initial/update status of incoming events. Tracking reportable cases and reporting to regulatory authorities as per legislation, within timelines and in a format compatible to requirement. Liaising with local vendors, where applicable, to facilitate expedited reporting. Liaise with different functional team members to address project related issues and successes. Receive and document incoming emails from investigative sites or other sources reporting Lifecycle Safety data. Triage of cases, generate the CTMS list, preparing alert letter package, sending SUSARs to investigators and clinical teams on time, filing the eTMF pack in ELVIS. Ensure to meet quality standards per project requirements. Ensure to meet productivity and delivery standards per project requirements. To ensure compliance to all project related processes and activities. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. Creating, maintaining and tracking cases as applicable to the project plan. Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. May liaise with client in relation to details on day to day case processing activities. To mentor new teams members, if assigned by the Manager. Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. Perform other duties as assigned. Lead/ Support department Initiatives 100% compliance towards all people practices and processes Qualifications High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req Bachelor's degree in life sciences or related field and 2 years or more experience (Knowledge & Experience Required) on ICSR submission to Regulatory Authorities, Ethical Committees, and Investigative sites. Experience in Clinical Trial and Post Marketed ICSR Regulatory Reporting or any kind or Regulatory Submissions. Experience of “determining and assessing ICSR reportability to various regulatory authorities based on appropriate regulatory intelligence”. Knowledge about concepts of Clinical Trial and Post Market reporting ICH E2B should be beneficial on cross reports across licenses of a pharmaceutical product. Should have experience and knowledge of various formats of ICSR reporting that is submitted to Regulatory authorities, like xml format for EVWEB upload, E2B gateway reporting and transmission, Portal submissions, courier and manual email submissions of CIOMS, MEDWATCH. Experience in ICSR regulatory submission and regulatory guidelines for Drugs/vaccines for various countries. Knowledge of automated and manual scheduling of regulatory reports in safety database. Includes initial report, follow up regulatory report, amendment report scheduling, nullification report, downgrade report. Good knowledge of medical terminology. Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate. Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate Excellent attention to detail and accuracy. Intermediate maintain high quality standards. Intermediate Good working knowledge of Microsoft Office and web-based applications. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate Ability to delegate to less experienced team members. Intermediate Ability to be flexible and receptive to changing process demands. Intermediate Willingness and aptitude to learn new skills across Safety service lines. Intermediate Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate Ensure quality of deliverables according to the agreed terms. Intermediate Demonstration of IQVIA core values while doing daily tasks Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Intermediate IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com