1738 Pharmacovigilance Jobs - Page 12

Job Overview Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. 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 characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author 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 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 to maintain compliance 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, statement of work (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. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelor's Degree Bachelor's Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. 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

Job Overview Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. 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 characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author 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 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 to maintain compliance 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, statement of work (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. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree Bachelors Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. 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

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. Essential Functions Act as primary author & or reviewer/QCer of SARA deliverables involving aggregate reports, signal management or literature review projects. Lead, author and finalize small to medium aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Specialist on post-marketing and clinical trial projects. Author all types of signal management deliverables. 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 characterization of risks. Participate as core member and present in safety management teams. Responsible for full documentation and tracking of signals. In a PV support role, author 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 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 to maintain compliance 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, statement of work (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. Support and/or contribute to technology / innovation activities. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree Bachelors Degree Req 1 - 3 years of prior relevant experience in areas of drug safety, aggregate reporting, signal management, or literature surveillance. Pref Equivalent combination of education, training and experience. Req Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Strong organizational skills and time management skills. Intermediate Strong verbal/written communication skills. Intermediate Self-motivated and flexible. Intermediate Excellent attention to detail and accuracy. Intermediate Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate Proven ability to multi-task, manage competing priorities and deadlines. Intermediate Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate

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. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 3 - 4 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

At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet and our enterprise. Making animals lives better makes life better join our team today! Company Overview: At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet, and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals lives better makes life better join our team today! Your Role: [Associate/ Senior Associate Manager Aggregate Report Writing] As an Associate/ Senior Associate Manager Aggregate Report Writing, you will be part of Global Pharmacovigilance team to deliver veterinary pharmacovigilance documents for regulatory submission and internal use. The purpose of this role is to ensure the provision of comprehensive, high quality, scientifically accurate and consistent medical information in consultation with the Global Pharmacovigilance team. Your Responsibilities: Author/review of routine regulatory documents including, but not limited to aggregate reports (PSURs, PDER), Annual Signal Management Reports, and literature searches and occasionally other regulatory documents such as Risk Management Plan, Benefit-Risk Evaluation reports and Ad hoc PSURs required in accordance with applicable regulatory requirements. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Support Regulatory Affairs team in the timely submission of Regulatory dossier for the initial or renewal of product registrations. Maintaining and completing Veeva Vault RIM tasks on time. Collaborate with regulatory affairs, quality assurance, and clinical teams to gather relevant data and ensure consistency. Liaise with global affiliates, and regulatory authorities when necessary. Ensure documentation and processes are audit-ready and support regulatory inspections when applicable. Participate in training and continuous improvement activities related to pharmacovigilance and PSUR processes. What You Need to Succeed (minimum qualifications): Education : i. e. Graduation in veterinary medicine/ post-graduation in pharmacy or any other life science background. Experience : A minimum of 3 - 5 years of industry experience in PV or medical writing. Excellent oral and written communication skills with ability to communicate logically and technically with global stakeholders. High competency in Microsoft Office applications. In-depth knowledge of GxP requirements and regulatory guidelines with sound understanding of operational Regulatory and R&D principles. What will give you a competitive edge (preferred qualifications): Ability to work independently or as part of a team and collaborate with global teams cross geographies and time zones. Experience with electronic document management systems (e. g. , Veeva Vault), Mastery of templates, styles, and submission-ready formatting. Additional Information: Travel percentage up to 10%, annually. Location: IN, Bangalore - Hybrid Work Environment Don t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but dont necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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. Generates, analyzes, and summarizes aggregate safety data to discern new signals and, as required, commences benefit-risk evaluation and determines risk-mitigating activity. Collaborates with client and regulatory stakeholders and internal project teams to determine the safety analysis required; performs the search for applicable safety data; aggregates, analyzes, and archives the safety data; completes templates for reporting and evaluating signals or benefit-risk analysis; and publishes and submits aggregate safety reports to regulatory bodies on behalf of contracted clients and corresponds with regulatory bodies as required. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 4 - 6 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

Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure. Essential Functions Serve as a stand-alone global lead for aggregate reporting, signal management, or literature survellance projects. Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings and author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to conduct 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 &/or signal detection relevance review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee/set-up and update products signaling strategies. Oversee/author and/or QC review all types of signal management deliverables. Oversee/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 . Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections. In a PV support role, act as functional lead and oversee/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Provide training to SARA staff for qualification on SARA deliverables May perform quality check of all assigned SARA deliverables be responsible for the quality of the final SARA deliverable to client regulatory, IQVIA regulatory reporting (RR), and regulatory authorties. Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables. Act as mentor to and coach to project team staff and direct line reports. 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), Business development (BD) and Proposals, and Information Technology (IT), as needed Participate in internal and external audits, as required. Lead audit preparation activities in advance to audit and ensure audit readiness of project Review project files and contact lists on a regular basis to ensure compliance with SOPs Lead functional team and contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. 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. Ensure Good Documentation Practices (GDP). Serve as the interface between the global project lead and the working team conduct regular lessons learnt 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, statement of work (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. Contribute to resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions. Build a positive, collaborative team environment with SARA team members, lead by example and provide training and mentoring for local project leads and less experienced team members. Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies. Participate in the review of existing standard operating procedures (SOPs). Proactively identify issues and propose solutions. Provide consultative guidance to internal and external stakeholders for all SARA deliverables. Suggest, drive, and implement continuous process improvements across all SARA center services. Collaborate with line managers to resolve project performance related issues of staff. Qualifications Bachelors Degree in a Scientific or Healthcare discipline Req 4 - 6 years relevant work experience pref. Equivalent combination of education, training and experience. Req Extensive knowledge of Lifecycle Safety processes, audit practices, governing safety legislation/regulation. Advanced willingness to increase knowledge across IQVIA Safety service lines and develop new skills. Advanced Extensive knowledge of applicable global, regional, local regulatory requirements. Advanced i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Advanced Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Advanced Strong organizational and time management skills. Advanced Proven ability to follow instructions/guidelines, work independently and own initiative(s). Advanced Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Advanced Excellent understanding of operational metrics, productivity and initiatives. Advanced Excellent project management, leadership, and mentoring skills. Advanced Excellent presentation and customer-focused skills. Advanced Excellent judgment, decision-making and problem solving skills. Advanced Encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives. Advanced

Job Overview Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project/client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure. Essential Functions Serve as a stand-alone global lead for aggregate reporting, signal management, or literature survellance projects. Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings and author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer/QCers to conduct 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 &/or signal detection relevance review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines. Act as Signal Management Lead on large and/or complex post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee/set-up and update products signaling strategies. Oversee/author and/or QC review all types of signal management deliverables. Oversee/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 . Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections. In a PV support role, act as functional lead and oversee/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Provide training to SARA staff for qualification on SARA deliverables May perform quality check of all assigned SARA deliverables be responsible for the quality of the final SARA deliverable to client regulatory, IQVIA regulatory reporting (RR), and regulatory authorties. Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables. Act as mentor to and coach to project team staff and direct line reports. 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), Business development (BD) and Proposals, and Information Technology (IT), as needed Participate in internal and external audits, as required. Lead audit preparation activities in advance to audit and ensure audit readiness of project Review project files and contact lists on a regular basis to ensure compliance with SOPs Lead functional team and contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. 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. Ensure Good Documentation Practices (GDP). Serve as the interface between the global project lead and the working team conduct regular lessons learnt 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, statement of work (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. Contribute to resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions. Build a positive, collaborative team environment with SARA team members, lead by example and provide training and mentoring for local project leads and less experienced team members. Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies. Participate in the review of existing standard operating procedures (SOPs). Proactively identify issues and propose solutions. Provide consultative guidance to internal and external stakeholders for all SARA deliverables. Suggest, drive, and implement continuous process improvements across all SARA center services. Collaborate with line managers to resolve project performance related issues of staff. Qualifications Bachelors Degree in a Scientific or Healthcare discipline Req 4 - 6 years relevant work experience pref. Equivalent combination of education, training and experience. Req Extensive knowledge of Lifecycle Safety processes, audit practices, governing safety legislation/regulation. Advanced willingness to increase knowledge across IQVIA Safety service lines and develop new skills. Advanced Extensive knowledge of applicable global, regional, local regulatory requirements. Advanced i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Advanced Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Advanced Strong organizational and time management skills. Advanced Proven ability to follow instructions/guidelines, work independently and own initiative(s). Advanced Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Advanced Excellent understanding of operational metrics, productivity and initiatives. Advanced Excellent project management, leadership, and mentoring skills. Advanced Excellent presentation and customer-focused skills. Advanced Excellent judgment, decision-making and problem solving skills. Advanced Encourage a flexible and receptive approach to changing demands and proven ability in the implementation of new initiatives. Advanced . 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

Job Title: Medical Advisor Walter Bushnell Desired Candidate Profile: MBBS, MD –Pharmacology/medicine or any specialty Mandatory-Candidate should be from well recognized Reputed Govt Institute. Desired year of experience: 2 to 5 years in Pharma. Domestic –India Reports to: Head - Medical & and Regulatory Affairs Roles and Responsibilities: · Excellent Medical Writing Skills · Excellent interpersonal and communication skills · Should be proficient in word /PowerPoint and excel · Will be expected to Support sales force trainings, present science news, activity plans etc. · Candidate should address scientific queries received from sales/marketing/doctors with sound scientific back-up · Should possess ability to present scientific content at academic meets like CMEs, conferences, advisory boards etc. · Provide pre-launch and launch training to sales staff for new products · Approval of promotional inputs as per regulatory guidelines/pharma marketing codes · Involvement in strategies and planning for launch of new indication/products including KOL engagement and medical education. · Building a professional rapport with Key Opinion Leaders through field visits · Liaison with KOLs to build and drive scientific advocacy for the product/therapy area · Candidate will devise phase 4 post-marketing studies incl. registries, RWE, observational studies · Should be aware of Pharmacovigilance process and adverse event reporting. · Candidate will collaborate with the marketing department to develop marketing strategies · Provide inputs in new product evaluation and product pipeline for future launch . Travel for Cycle meetings, Conference participation and other medico-marketing activity CV can be emailed to purnima.chauhan@walterbushnell.com arunprashant.baxla@walterbushnell.com

W e're Hiring: Junior Pharmacovigilance Specialist Location: Pune | Full-Time | Entry-Level / 0–1 Year Experience Are you a Life Science or Pharmacy graduate looking to kickstart your career in Pharmacovigilance ? Join our growing team and play a key role in ensuring drug safety and patient well-being through adverse event reporting and regulatory compliance. 🔹 Role Highlights ✔ Analyze & process adverse event reports ✔ Prepare regulatory safety submissions ✔ Follow GCP, GDP, ICH & MedDRA coding standards ✔ Collaborate with project managers and team leads ✔ Ensure data accuracy and audit readiness 🔹 What We’re Looking For 🎓 B.Pharm / M.Pharm Graduates 🧠 Freshers 📊 Familiarity with MedDRA, CTC, MS Office, PubMed/Embase 💬 Excellent communication and documentation skills 🤝 Team player with strong attention to detail 📩 Apply Now www.medexcode.com/careers

Job Title: Medical Data Abstractor (MDA) Department: Delivery Job Location: Turbhe, Navi Mumbai (Work from Office) Reporting To: Lead Job Duties / Responsibilities: Data management and Curation Performs complex data abstraction (i.e. requiring interpretation) and data entry for specified disease and project requirements. Participates and contributes to team meetings and learning sessions. Maintains a high level of medical knowledge and terminology and expertise of electronic medical record and data capture systems. Self-reports activities like time spent on records, audits completed including all relevant details and any other reporting functions assigned by Operations and QA management teams. Quality Assurance Consistently complies with minimum quality levels indicated in the QA plan for each project (>95% or higher accuracy depending on the project). Receives feedback from Quality Analyst and ensures timely reconciliation of errors. Participates in quarterly Inter rater reliability (IRR). Special Projects May lead or participate in special projects or client-specific initiatives as directed. Education and Experience: Graduate / PG - Medicos: BDS, MDS, BAMS, BUMS, BHMS, BPT, MD. 0-5 years of experience in the clinical or non-clinical field. Should be presentable and pleasant. Ability to multitask, work under pressure, and meet deadlines required.,

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma). Experience: 1-3 Years.

Roles and Responsibilities: Perform coding of Adverse Events , Medical History, Indications, and Concomitant Medications using MedDRA and WHO Drug Dictionary. Ensure accurate and consistent data entry within global safety databases. Review case narratives and source documents to assign appropriate codes. Maintain compliance with ICH, GVP, and company SOPs. Coordinate with case processors, medical reviewers, and QA teams to resolve coding discrepancies. Stay updated with MedDRA and WHO-DD version updates and apply changes. Participate in coding audits, quality control, and data consistency checks. Support safety signal detection and regulatory queries with coded data. Qualifications: Bachelors degree in Pharmacy, Life Sciences, Nursing, or related field 2-5+ years of experience in pharmacovigilance or medical coding Hands-on experience. Familiarity with PV software. Basic understanding of ICSR and pharmacovigilance workflow. Certification in pharmacovigilance or medical coding is preferred. Interested to apply can share CV or call/WhatsApp to 9342735755

We are seeking a highly detail-oriented MedDRA Coder to support our Drug Safety and Pharmacovigilance operations. The ideal candidate will be responsible for the accurate and consistent coding of adverse event terms using MedDR , ensuring compliance with regulatory and quality standards. Roles and Responsibilities Code Adverse Event terms using MedDRA for clinical trials, post-marketing safety reports, and spontaneous reports. Ensure consistency and accuracy in medical terminology coding across safety databases. Collaborate with safety physicians, case processors, and medical reviewers to ensure appropriate interpretation and classification. Maintain knowledge of current MedDRA updates and implement changes into the safety database. Perform quality checks and reconciliation of coded data. Support regulatory submissions by ensuring properly coded safety data. Participate in coding conventions , coding guideline development, and audit preparedness. Qualifications Bachelors degree in Life Sciences, Pharmacy, Nursing, or related field. 1-3 years of experience in drug safety coding using MedDRA Knowledge of global regulatory guidelines. Excellent communication and attention to detail. Interested to apply can share CV or call/WhatsApp to 9342735755

Associate Manager, Pharmacovigilance Mumbai, India (hybrid role: 3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed, and detail-oriented pharmacovigilance professional with 8+ years of total PV experience, including a minimum of 4-5 years in authoring aggregate safety reports and Risk Management Plans (RMPs) and have additional experience overseeing ICSR compliance activities at both local and global levels, then we would love to hear from you. Join us to help improve peoples' lives and make healthcare better for everyone! Why Pharmanovia? Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are: We act decisively but we never compromise on quality. We keep our promises and do as we say. We value our heritage and foster an entrepreneurial spirit. We reinvest in our future - in our products, our brands and our people. We give back to our communities. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore. We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology. Main responsibilities & duties: Prepare and author aggregate safety reports and regulatory documents, including PADERs, Summary Evaluation Reports (SERs), and Serious Adverse Reaction (SAR) reports Prepare and author Risk Management Plans (RMPs) Provide strategic oversight and operational management of SDEAs, including authoring, reviewing, and ensuring ongoing compliance Ensure compliance with ICSR submission timelines and partner obligations Develop and maintain internal processes to support core pharmacovigilance activities Support and participate in pharmacovigilance audits and regulatory inspections Contribute to product labelling activities based on safety data and evolving benefit-risk profiles Monitor and assess regulatory intelligence updates and implement necessary changes to PV systems and practices Assist with pharmacovigilance risk assessments and due diligence activities for new products or partnerships Develop, track, and report key performance indicators (KPIs) to senior leadership for informed decision-making Collaborate cross-functionally with internal leadership teams to ensure PV oversight aligns with broader business goals About you: Candidates with progressive pharmacovigilance experience, specifically in authoring aggregate reports, RMPs, as well as management and oversight of SDEAs and ICSR compliance activities, should have the skills and experience required for the role. We are also looking for: Bachelor's degree in Pharmacy (Master's degree desirable) 8+ years of experience in pharmacovigilance with minimum 4-5 years of experience in authoring aggregate reports/RMPs is essential. Experience in working with core pharmaceutical companies desirable Strong knowledge of PV regulations at local and global level Experience in management of SDEAs Experience in ICSR review and compliance monitoring Organised and inquisitive, with problem solving skills Solid time management skills, the ability to multitask and see the big picture Strong technical skills Adaptability and resilience What we offer: We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working. By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.

Opportunity For Clinical Coordinator on Yearly fixed term renewable contract for our hospital payroll in Mahim. Position: Clinical Co-ordinator ( * Please note, this is not a Clinical research profile. ) Qualification: BSc, Additional Qualification in Computer applications will be an advantage Experience : 0 to 10 years Job Description: Keeps the Patient Appointment Folders ready in coordination with the MRD and support staff Ensures Billing coordination and mapping the vouchers equivalently with the respective patient folders Observes patients physical condition and emotional changes and adequately reports the same to registered nursing professionals. Utilizes techniques of reality orientation when dealing with disoriented or potentially disoriented patients, maintains a safe, clean comfortable hospital environment. Recognizes potential environmental safety and health hazards, assists in implementing hazard prevention methods and disaster plans. Knows the infectious process and modes of disease transmission and assists in ensuring effective infection control practices during patient care. Assist with physical and diagnostic examinations. Any other duties that may be assigned from time to time by the nurse in charge. Coordinate with the medical officers as required. Coordinate with the Hospital attendants for Palliative patients shifting. Is responsible for Patient Linen management and patient mobility assistance as needed. Call the patients for consultation from the waiting area. Help the patient with the queries as required. Assist with Data retrieval from Investigations or referrals done. Assist with patient coordination for Diagnostics, New appointments, Admission, Surgery booking, Follow up or referrals with other Consultants. Coordinates Consultant Room management for Equipment function control, adequacy of chargeable/nonchargeable medical and nonmedical consumables. Answering patients queries and providing clarification as and when required throughout the course of their process. Coordinating between patients and hospital stakeholders to enable/ facilitate quality service delivery Regards, Ankita Shetty HR 022-69237426

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. : Department - Discovery Qualification - MSC - Organic Chmeistry Role - Trainee Mode - Internship Stipend - 16000 Location - Hyderabad Qualifications MSC - Organic Chemistry

Job Summary We are looking for the Primary scientific face of the organization to ‘Thought Leaders’ & physicians for a given therapy area. You will be responsible for Identification, mapping and profiling of thought leaders of given geography and therapy area, on an ongoing basis. Roles & Responsibilities • You will be responsible for the engagement of identified key thought leaders through medical affairs activities, in alignment with the overall strategic plan • You will be responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects • You will be a therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients’ treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart • You will be responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals • You will have to represent the organization in various internal & external scientific platforms • You will have to gather deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams. • You will need to proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan • You will be receiving and processing scientific information requests received from physicians • You will have to ensure that all activities in the region are conducted in alignment to organisation’s COBE (Code of Business Ethics) Policy and compliance guidelines. • You will need to collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in reputed journals. • You will be responsible for devising an optimal training plan to ensure the flow of the latest medical developments to the sales and marketing teams. • You will jointly be responsible with the therapy area lead to support optimal patient outcomes through communication of data, information, knowledge, and insights in support of healthcare professional needs and organizational goals. • Representing the organization in various internal and external scientific platforms will be among your responsibilities. • You will be responsible for developing the Medical Affairs strategic plan for identified therapeutic areas and products. • Your ability to convert insights on disease trends and treatment patterns from key thought leaders into viable and formidable strategic plans to shape the therapeutic areas of interest will be vital. • You will be responsible for identifying knowledge gaps, practice gaps, and data gaps and developing strategic medical action plans, including but not limited to medical education, product education, evidence generation, and special projects, will fall under your responsibility. • Collaborating with thought leaders to conduct therapy-specific reviews, meta-analysis, case studies, case series, patient-reported outcomes, and publishing them in reputable journals will be part of your role. • Handling complex questions from healthcare professionals related to GGI products or disease areas to satisfaction will be a key responsibility. • You will be responsible for ensuring that all activities in the therapeutic area are conducted in alignment with Dr. Reddy's COBE (Code of Business Ethics) Policy and compliance guidelines will be essential. • You will be responsible for ensuring that all promotional, physician, and patient education materials are approved within stipulated timelines and in alignment with Dr. Reddy's Promotional Material approval policy. • As a product pipeline champion, you will have the ability to identify unmet needs through active stakeholder interactions and actively contribute to the new product ideation and development of differentiated products. Qualification Educational Qualification- MBBS with full time post-graduate qualification of at least 2-years’ duration in any discipline of medicine/ M.B.B.S with M.B.A. from a reputed institute Minimum work experience- Fresh postgraduate or up to 2 years of experience in Field based Medical Affairs . Skills & attributes – Good understanding of therapy area - Oncology Abiity to read and interpret the clinical trails Knowledge about business landscape. Technical Skills • Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data • Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship • Experience with complex business environments preferred • Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. . Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving 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 incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for? sBachelor Degree in Life Sciences Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts, Any Graduation

Site Name: India - Karnataka - Bengaluru, Hyderabad Wework Krishe Emerald Posted Date: Jul 18 2025 Job Purpose: Provide scientific and technical expertise of the highest standards for local medical information, including interactions with Key External Experts (KEEs) and Key Opinion Leaders (KOLs) Provide medical and scientific input and information for business strategy for the region. Key Responsibilities : Develop and sustain credible networking with appropriate Health Care Practitioners (HCPs) Plan, facilitate and conduct CMEs, symposia, trainings, workshops, scientific meetings, speaker tours, and other product specific campaigns and deliver scientific presentations with consistent messages for key products at these meetings, as required. Support and deliver scientific presentations with consistent “on label” messages at medical education meetings. Understand principles of and support Scientific Engagement (SE) activities as per Medical Plans. Have clarity in understanding on Scientific Engagements and Promotional Code. Become an expert in oncology where GSK have brands and support associated activities related to those brands. Be updated on scientific knowledge on oncology; GSK molecules and its PI to ensure its ‘On Label’ communications on various platforms. Support in feasibility assessment of potential research sites, develop concept notes, proposals, budgets, data collection and monitoring tools for field studies. Provide medical inputs into development and execution of brand strategy. Pharmacovigilance: Support Named Safety contact in strengthening of oncology Pharmacovigilance; ensure self-learning. Knowledge/ Education / Previous Experience Required Educational Background :- Minimum Level of Education - MBBS with post graduate qualification Preferred Level of Education - Post graduate qualification in Pharmacology / Public Health Why is this Level of Education Preferred - To interact with specialized HCPs Job-Related Experience:- Minimum Level Of Job-Related Experience Required Excellent written and oral communication skills in English, local language Experience of presenting scientific topics at different settings A sound understanding of the principles and practice of ICH-GCP and internal SOPs. Well-demonstrated ability to understand scientific methods and experimental design. 1-2 years in the pharmaceutical industry preferably in the oncology therapy area. Other Job-Related Skills/Background:- General Competencies Presentation skills at Scientific meetings Communication skills, both verbal and written Technical writing skills Keep up to date with new developments Ability to provide and receive constructive feedback Build and maintain relationships with colleagues Share knowledge with other team members Work as part of a team to reach common goals Deliver creative ideas for continuous improvement Develop good relationships with key opinion leaders Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

Responsible for handling end to end Case management (ICSRs) activities and to ensure the compliance. Manage assigned team and ensure that all tasks are performed according to guidelines and standard operating procedures. Consulting and guiding the pharmacovigilance team for completion of aggregate reports (PSURs, PADERs, RMPs and applicable regulatory submission PV documents) as required for regulatory submission To develop and review pharmacovigilance SOPs. Coordination with MICC for ICSR activities and regulatory compliance. Coordinating the safety data exchange agreements between Hetero and business partners. Responsible for providing guidance and training to team as and when required. Responsible for identifying, implementation and continuous improvement activities. Responsible to handle audits and inspections

Prior experience in monitoring adherence to compliance-based training programs. Demonstrated ability to influence and negotiate effectively. Ability to implement large-scale change in complex, matrix organizations Required Computer Experience: LMS administration and processing; proficiency in Microsoft Office, Adobe Acrobat, Sharepoint development and maintenance, course development products (Articulate, Storyline) and survey tools. BS – 7 years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical. MS – 5 years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical. Ph.D./PharmD/ MD – 3 years in pharmaceutical industry with focus on pharmacovigilance, regulatory and clinical. Experience working globally with organizations/teams/individuals As the training development lead, work with stakeholders including global business and functional lines in support of Drug Development training and education. This includes cross functional study teams, functional area teams, vendors/contractors, and regional development areas. Key relationships include senior leaders and area experts. #LI-REMOTE

JOB DESCRIPTION Job Purpose As a Therapy Business Manager you will be responsible for developing and implementing all sales strategies in the assigned market. Further you will drive primary and secondary sales, ensure brand presence in the assigned market and manage the distributor network to achieve desired sales/business objectives. Roles and Responsibilities in detail Business generation & development: Achieve monthly, quarterly, half yearly and yearly sales target by promoting company’s product ethically to customers as per the business plan Having science-based discussion with doctors and chemists for promotion of product in clinic and at chemist place Organizing Camps (CME) as per the division strategy and customer needs To plan and conduct merchandising and sampling activity as per Division strategy. Facilitate the process of successful new product / products launch in the territory by undertaking correct identification and targeting customers for the new product, meet them at pre-determined intervals, effective in clinic / trade promotion and share feedback with the company Execute the customer management plan to ensure that all the customers are covered as per the plan and meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division / therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy / division. Prescription audit for Abbott brands and other competitors’ brands To create and update customer list having specified number of doctors / chemist (Trade) as per the therapy / product requirement and maintain the same in physical / electronic format. Identifying potential town and appointing distributor and customers (trade) in line with business philosophy Brand Management: Ensuring the visibility of Abbott brands on retailers’ outlet as a part of brand promotion strategy To carry out activities across trade and clinics for brand visibility To plan and attend Retail meets, Market Blitz etc. for sales growth Generate POBs for Abbott brands as per the business plan Recommend appointment of a party as a distributor after evaluating its commercial standing, credit worthiness and personal assets. Ensure that stock and sales statements have been sent by the distributors on due dates Ensure that the claims of the distributors are settled by company within specified time limits You are manager of the company in your territory and will be authorized to build company’s reputation in your territory. You will be responsible for practicing and leading other junior team members of the company by setting personal example of excellence in: Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, FCPA , Pharmacovigilance to ensure compliance Conformation to all financial and administration systems, compliance to statutory and regulatory norms of the company and laws of the land Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring and Enduring Ensure high level of customer service and manage any difficult customer situations. Ensure compliance with internal and external guidelines and ensure minimal comments in audits and other inspections Ensure transactions and orders are processed with a high level of accuracy and commitment in order to satisfy customer needs Manage attrition of customer and resource bases Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programmes and any other programmes undertaken by the company to equip you or activities for performance of your job or promote the sales of product of the company or to improve company image. Ensure adherence to EHS policies, procedures, rules and regulations. Attend all required EHS trainings as applicable. Wear safety gears (e.g. Helmet) while riding on two-wheeler. Report any EHS incidents and/or near misses (unsafe acts and conditions) promptly to supervision. Forward any opportunities to improve the EHS program to supervision.

at least 3 months internship at hospitals B.pharm, diploma/ certification in Clinical Research, good to done internship for few months at any hospital, good communication skills, can speak Infront of doctors or in chamber of doctors JD: Done feasibility start -up activities till Site initiation

5 yrs experience on global clinical trials, including CRC CRA experience Having CRA team management experience must JD: Offer handholding to CRC's, stie start up specialist for activities like identifying potential doctors to close out of the trial from end to end all trial conduct activities Onsite visit for purpose of SIV, IMV, Close out visit, any audits by stakeholders Market research of feasible hospitals Area: Nagpur, Raipur, Aurangabad, Pune