543 Medical Writing Jobs - Page 18

Greetings From Sri Sai Medicode Clinical Data Management Freshers Location - Tirupati Only.. Offline Training With Placement Qualification - Any Life sciences Graduates Only CV's On Mail - srisaimedicode@gmail.com Clinical Research Also

Vijaya Diagnostics Limited Location: Pune Position: USG Typist Transcribe ultrasound reports (USG) accurately from dictated recordings or handwritten notes into digital format. Review and verify the accuracy of reports for spelling, grammar, and medical terminology. Maintain confidentiality of patient information in compliance with healthcare regulations. Organize and manage electronic and paper-based medical records related to USG procedures. Collaborate with radiologists, sonographers, and healthcare professionals to clarify reports as needed. Ensure timely completion and submission of reports to facilitate prompt patient diagnosis and treatment. Assist in maintaining the overall workflow of the radiology department. Interested candidates are encouraged to share their updated CV at lovenahar@vijayadiagnostic.in or call 8121011041 for further information. Regards, Talent Team Vijaya Diagnostics Limited, Pune

Vijaya Diagnostics Limited Location: Pune Position: USG Medical Typist Transcribe ultrasound reports (USG) accurately from dictated recordings or handwritten notes into digital format. Review and verify the accuracy of reports for spelling, grammar, and medical terminology. Maintain confidentiality of patient information in compliance with healthcare regulations. Organize and manage electronic and paper-based medical records related to USG procedures. Collaborate with radiologists, sonographers, and healthcare professionals to clarify reports as needed. Ensure timely completion and submission of reports to facilitate prompt patient diagnosis and treatment. Assist in maintaining the overall workflow of the radiology department. Interested candidates are encouraged to share their updated CV at lovenahar@vijayadiagnostic.in or call 8121011041 for further information. Regards, Talent Team Vijaya Diagnostics Limited, Pune

1.1 Job Description The research associate will need to gather Information from publicly available resources as well as commercial resources. 1.2 Responsibilities Gathering data from primary and secondary sources of information. secondary searches using various sources like doctor homepage, PubMed, conference, Association, Industry or Pharma companies, etc) Verification and Validation of physician/doctor information for appropriate Affiliation, Specialty, Nationality & Postal code Reporting to Team Leader 1.3 Skills Technical understanding in life science related information like therapeutic area, specialty. Self-starter with good interpersonal, comprehensive and communication skills. Good grasp and understanding & explaining capabilities Web research capabilities Proficient in Microsoft Office (Word, PowerPoint, Excel) Experience and basic skills in searching for scientific data and information Strong attention to detail and a strong analytical mind

RoleClinical & Therapy Development Manager Type Full Time Job description - Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops) This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Job Description Job Overview Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

Regional Medical Advisor (RMA) - General Specialty Medicine, East Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities and Primary Activities Scientific Expertise : Develop and maintain a comprehensive understanding of the companys products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement : Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the companys products and therapeutic areas. Support to Medical Strategy : Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education : Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange : Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication : Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support : Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration : Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives : Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information : Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training : Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance : Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background : A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience : At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise : Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge : Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills : Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills : Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility : Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge : Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Job Posting End Date: 06/30/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Regional Medical Advisor (RMA) - General Specialty Medicine, South Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities and Primary Activities Scientific Expertise : Develop and maintain a comprehensive understanding of the companys products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement : Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the companys products and therapeutic areas. Support to Medical Strategy : Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education : Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange : Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication : Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support : Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration : Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives : Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information : Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training : Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance : Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background : A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience : At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise : Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge : Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills : Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills : Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility : Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge : Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Job Posting End Date: 06/30/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Regional Medical Advisor (RMA) - General Specialty Medicine, North Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities and Primary Activities Scientific Expertise : Develop and maintain a comprehensive understanding of the companys products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement : Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the companys products and therapeutic areas. Support to Medical Strategy : Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education : Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange : Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication : Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support : Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration : Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives : Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information : Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training : Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance : Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the companys strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background : A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience : At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise : Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge : Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills : Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills : Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility : Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge : Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Required Skills: Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Job Posting End Date: 06/30/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Fresher Hiring 2023 - 2025 Passouts only - All India Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Role & responsibilities Perform data reconciliation between different data sources and study documents to ensure data integrity and consistency across datasets. Generate data queries to address discrepancies, inconsistencies, and missing data identified during data review, ensuring timely resolution and documentation of data queries Communicate data queries to investigative sites, data managers, and study personnel, following up on query responses and resolving discrepancies in collaboration with relevant stakeholders Identify deviations from protocol-specified procedures, eligibility criteria, and data collection guidelines, escalating issues to appropriate personnel for resolution Perform quality checks and data validation procedures to ensure accuracy, consistency, and reliability of clinical trial data, adhering to data management standards and industry best practices Assist in the development and implementation of data validation plans, data review guidelines, and quality control procedures to maintain high standards of data quality and integrity. Assist in a variety of specialties including but not limited to primary care, orthopedics, rheumatology, etc. Updates patient history, physical exam, and other pertinent health information in the document as required. Complies with Compliance standards of the Organization as laid by HIPAA. Performs other duties and tasks to improve provider productivity and workflow as assigned by supervisors. Assist documenting the patients, electronic health record (EHR). Fresher Hiring - Pharma / Life Sciences / Medical Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Location - All India - Delhi, Mumbai, Pune, Bangalore, Kochi, Chennai, Hyderabad, Ahmedabad, Bhopal, Indore, Kolkata, Chandigarh

converting doctors' dictations into written reports, including patient histories, progress notes, and other clinical documents. Experience in diagnostic and medical segment.

converting doctors' dictations into written reports, including patient histories, progress notes, and other clinical documents. Experience in diagnostic and medical segment.

Provide highly advanced expert support functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other RD areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and systems -Strategically and tactically supports Director Clinical Data Standards. Responsible for advising/leading the planning, development and implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. May lead global teams Key Responsibilities Study Level- Responsible for all statistical tasks on assigned clinical or non-clinical trials, and perform these tasks for high complexity trials with a high level of independence seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, and reporting activities. Contribute to planning and execution of exploratory analyses, innovative analyses related to publications and pricing reimbursement submission and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs and dose-finding strategies in alignment with the Lead Statistician. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, pricing agencies and other drug development activities, as required. Independently lead interactions with external review boards/ethics commit-tees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the clinical trial team and Biostatistics Pharmacometrics team. Independent oversight of all Biostatistics resources and deliverables for as-signed trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level- Responsible for strategic statistical input and influence into one or more projects (development plan, regulatory strategy, publication strategy, pricing reimbursement strategy, statistical deliverables). May be a core member of one or more early project teams representing Bio-statistics and Pharmacometrics. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful im-pact on robust drug development plans. Collaborate cross-functionally (eg, with data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables. Facilitate seamless transition of projects from early to late development. Effective partnership with other functions to ensure integrated quantitative in-put into project. Propose and implement innovative designs and methods to optimize drug development. Plan, prioritize and oversee project level statistical activities and ensure efficient resource management and effective partnership with vendors. Drive adherence to organizational standards and regulatory guidelines. Represent Biostatistics and Pharmacometrics at internal and external decision boards (eg regulators) Significantly contributes to project team preparation and may play a prominent role representing Biostatistics at HA meetings. Disease Area / TA/Indication level: As partner to clinical and scientific leadership, drive strategic statistical input and excellence to development programs within the assigned TA/DA/indications. Franchise or Global Line Function level: Lead or significantly contribute to initiatives at global line function level, or cross-functional Franchise level, requiring coordination of diverse of team members. May contribute to line function review. Enterprise level: Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Represent Biostatistics in due-diligence teams for low- to mid-complexity in-licensing opportunities with supervision. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewe'd journals, presentations and chairing sessions at professional meetings. External: Represent Biostatistics and Pharmacometrics in interactions with external re-view boards/ethics committees, external consultants and other external parties with increasing independence. Chair sessions at professional meetings. People Management: Develop and mentor statisticians. As a local manager, responsible to recruit, retain and professionally develop up to 8 biostatisticians. Role Requirements- MS (in Statistics or equivalent) with 10+ years relevant work experience or PhD (in Statistics or equivalent) with 6+ years relevant work experience Fluent English (oral and written) Strong interpersonal and communication skills bridging scientific and business needs. Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Demonstrated excellence in use of statistical software packages (eg SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign. Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies. May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates. Good business ethics

The Associate Medical Expert in TCO (Translational Clinical Oncology), is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical support for assigned aspects of a global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) and / or Medical Expert TCO (Translational Clinical Oncology) is a department under Biomedical Research division, and is responsible for designing and executing out early phase (first in human) clinical studies in patients with cancer. It acts as a bridge between drug discovery and late phase clinical development and strives to deliver transformative new medicines for oncology conditions. About the Role Major accountabilities: Provides medical support to Clinical Program Leader (CPL) and / or Medical Expert. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (eg, Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. Contributes to clinical/scientific elements of TCO - related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc Contributes to the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Supports conduct of dose escalation meetings, investigator teleconferences and site initiation visits etc Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Advocate continuous improvement of quality Key performance indicators: Evidence of high-quality medical input to assigned studies to ensure execution according to timelines and ensuring adherence to international and local regulations. Evidence of quality medical and scientific review of clinical trial data Demonstrates excellent scientific writing skills to enable the development of high-quality documents including but not limited to clinical trial protocols, trial reporting (eg CSR), and regulatory documents (eg IB, DSUR). Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (eg, internal medicine / pharmacology etc) with medical council certification required. Experience in hematology / oncology preferred. Work Experience: At least 2 years of pharmaceutical/biotech industry experience or at least 4 years of clinical practice experience in the hospital setting Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to clinical or preclinical projects. Clear written and verbal expression of ideas, an active/proactive communicator. we'll-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Regulatory Compliance. Languages : English.

Job Overview Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate . 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

Executive - Medical Data Analyst Position Overview: The Medical Data Analyst will be responsible for analysing, sorting, and summarising complex medical records. The ideal candidate will bring strong expertise in medical records analysis, with a keen eye for detail and proficiency in medical data management tools. This role involves working on Med-Legal and life insurance projects, requiring accuracy and compliance with regulations like HIPAA and GDPR. Key Responsibilities: Medical Records Analysis: - Review, analyse, and summarise complex medical records and healthcare documentation. - Identify key medical events, diagnoses, and treatments relevant to legal or insurance purposes. Data Accuracy and Quality Control: - Ensure the accuracy and completeness of medical data by identifying inconsistencies, discrepancies, or missing information. - Perform quality checks and audits to ensure high standards are met across all data handling processes. Data Management and Software Proficiency: - Use data management software to handle, store, and organise medical records efficiently. - Familiarity with tools designed for medical records handling, such as Cased rive or similar systems. Analytical and Critical Thinking: - Apply critical thinking to interpret complex medical case histories and extract relevant data. - Analyse and summarise medical cases with attention to key details, timelines, and case relevance. Reporting and Communication: - Create detailed and concise reports that summarise medical data for internal teams and external clients. - Communicate complex medical information in a clear and understandable format. Time Management and Deadline Adherence: - Manage multiple projects simultaneously, meeting tight deadlines while ensuring high levels of accuracy. - Maintain consistent communication regarding project status and delivery timelines. Experience in Quality Assurance: - Conduct regular quality checks and audits to ensure that data accuracy and regulatory compliance are maintained. - Implement corrective measures to address any identified issues in the data. Adaptability and Learning Agility: - Quickly adapt to new software tools, processes, and changing project scopes. - Engage in continuous learning to stay up to date with the latest medical, legal, and technological developments. Med-Legal and Life Insurance Experience: - Apply experience from Med-Legal or life insurance projects, where the role of medical data is crucial for legal claims, settlements, or insurance adjudication. Regulatory Compliance Knowledge: - Ensure all work complies with relevant healthcare privacy regulations (HIPAA and GDPR). - Maintain strict confidentiality and security measures for handling sensitive medical data. Skills Required: - Strong proficiency in medical records analysis and healthcare documentation. - Exceptional attention to detail and commitment to accuracy. - Proficiency in data management systems and software tools. - Strong analytical and critical thinking skills. - Excellent communication and reporting skills. - Ability to work under tight deadlines without compromising quality. - Experience in quality assurance, auditing, and implementing corrective measures. - Ability to quickly adapt to new tools, processes, and workflows. - Experience in Med-Legal or life insurance projects. - In-depth knowledge of HIPAA/GDPR compliance and data privacy regulations. Education and Experience: A degree in healthcare, medical informatics, or a related field. Previous experience in medical data analysis, particularly in Med-Legal or insurance-based projects for at least 3 years. Role & responsibilities Preferred candidate profile

Executive - Medical Data Analyst Position Overview: The Medical Data Analyst will be responsible for analysing, sorting, and summarising complex medical records. The ideal candidate will bring strong expertise in medical records analysis, with a keen eye for detail and proficiency in medical data management tools. This role involves working on Med-Legal and life insurance projects, requiring accuracy and compliance with regulations like HIPAA and GDPR. Key Responsibilities: Medical Records Analysis: - Review, analyse, and summarise complex medical records and healthcare documentation. - Identify key medical events, diagnoses, and treatments relevant to legal or insurance purposes. Data Accuracy and Quality Control: - Ensure the accuracy and completeness of medical data by identifying inconsistencies, discrepancies, or missing information. - Perform quality checks and audits to ensure high standards are met across all data handling processes. Data Management and Software Proficiency: - Use data management software to handle, store, and organise medical records efficiently. - Familiarity with tools designed for medical records handling, such as Cased rive or similar systems. Analytical and Critical Thinking: - Apply critical thinking to interpret complex medical case histories and extract relevant data. - Analyse and summarise medical cases with attention to key details, timelines, and case relevance. Reporting and Communication: - Create detailed and concise reports that summarise medical data for internal teams and external clients. - Communicate complex medical information in a clear and understandable format. Time Management and Deadline Adherence: - Manage multiple projects simultaneously, meeting tight deadlines while ensuring high levels of accuracy. - Maintain consistent communication regarding project status and delivery timelines. Experience in Quality Assurance: - Conduct regular quality checks and audits to ensure that data accuracy and regulatory compliance are maintained. - Implement corrective measures to address any identified issues in the data. Adaptability and Learning Agility: - Quickly adapt to new software tools, processes, and changing project scopes. - Engage in continuous learning to stay up to date with the latest medical, legal, and technological developments. Med-Legal and Life Insurance Experience: - Apply experience from Med-Legal or life insurance projects, where the role of medical data is crucial for legal claims, settlements, or insurance adjudication. Regulatory Compliance Knowledge: - Ensure all work complies with relevant healthcare privacy regulations (HIPAA and GDPR). - Maintain strict confidentiality and security measures for handling sensitive medical data. Skills Required: - Strong proficiency in medical records analysis and healthcare documentation. - Exceptional attention to detail and commitment to accuracy. - Proficiency in data management systems and software tools. - Strong analytical and critical thinking skills. - Excellent communication and reporting skills. - Ability to work under tight deadlines without compromising quality. - Experience in quality assurance, auditing, and implementing corrective measures. - Ability to quickly adapt to new tools, processes, and workflows. - Experience in Med-Legal or life insurance projects. - In-depth knowledge of HIPAA/GDPR compliance and data privacy regulations. Education and Experience: A degree in healthcare, medical informatics, or a related field. Previous experience in medical data analysis, particularly in Med-Legal or insurance-based projects for at least 3 years. Role & responsibilities Preferred candidate profile

Job Title 1 : Salesforce Marketing Cloud Developer / Consultant Role & responsibilities Develop and implement campaigns using Salesforce Marketing Cloud tools Customize emails and landing pages using AMPscript and HTML/CSS Integrate SFMC with external systems via APIs Analyze campaign performance and optimize for engagement Collaborate with marketing and CRM teams to align strategies Job Title 2 : Medical Writer Role & responsibilities Design, develop, and deliver business solutions for the medical affairs division of pharmaceutical companies Contribute to medical publications and scientific content creation Facilitate medical education and information dissemination Manage medical grants and funding processes Organize and support advisory boards and advocacy programs Oversee regulatory review and approval of pharmaceutical drugs Perform publishing and quality control tasks on submission components Perks and benefits Home pick up and drop facility will be provided (within 40 kms of radius). Relocation assistance would be provided Subsidized food services available. Gym facility available on office premises.

As a Senior Clinical Transparency Lead you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence, What You Will Be Doing Assesses requirements for clinical trial registration / disclosure of results or public disclosure strategy plans, Prioritizes, oversees, and performs the day-to-day operations of Clinical Transparency or Public Disclosure, ensuring the timely completion, review and approval of registration, updates and results disclosure activities, Manages the review and approval process for clinical trial registrations or public disclosure tracking mechanisms, including communication with partner companies or collaborators, Facilitates periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required, Uses independent judgment to assess clinical transparency or public disclosure activities and problem solving to determine escalation of issues to management, Coordinates and oversees the work of consultants and vendors as applicable, Addresses inquiries related to clinical transparency or public disclosure activities, Provides feedback to Clinical Transparency or Public Disclosure leadership resulting from new and updated transparency requirements, Leads retrospective review to ensure compliance of trials resulting from new clinical transparency or public disclosure knowledge or requirements, Develops training materials, reference documents and tools for use with clinical transparency or public disclosure activities, Educates study or asset team members and other organizational contacts on clinical transparency or public disclosure policies and processes, Establishes and maintains global working relationships, Communicate changes throughout the client organization, Work cross-functionally to improve processes and address changes, Evaluate process automation, systems, and tools to improve efficiency, accuracy, and productivity, Lead clinical transparency or public disclosure training for global colleagues, You Are Bachelors Degree, or equivalent experience required, 5 years pharmaceutical industry experience required with experience in Transparency and/or Disclosure activities Working knowledge of clinical drug development and clinical trial protocols Excellent organizational skills and high attention to detail, Self-directed and motivated, with ability to work without significant direct supervision, asking questions when necessary, Ability to manage multiple tasks and readily switch activities to accommodate priority needs, Proficient computer skills, including experience with MSWord and Excel, Healthcare professional background preferred, What ICON Can Offer You Our success depends on the quality of our people Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent, In addition to your competitive salary, ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family, Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your familys needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers iconplc /benefits At ICON, inclusion & belonging are fundamental to our culture and values Were dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below, https://careers iconplc /reasonable-accommodations Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles,

Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Essential Functions Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

>To connect top practitioner doctors of different specialist all over India >To structure a proper process to establish & conduct medical survey for research & strategy purpose > Establish a proper compliance & register for conducting clinical trials

Role & responsibilities The candidate will have to create medical content as required The candidate will have to digitise medical documents as required The candidate will have to code the clinical documents as required Preferred candidate profile Masters or Doctor of Pharamcy Proficient in English language

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.