1729 Pharmacovigilance Jobs - Page 6

India - Hyderabad JOB ID: R-221140 ADDITIONAL LOCATIONS: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jul. 25, 2025 CATEGORY: Engineering As a Sr Associate IS Engineer, you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will engage with business users and functional SMEs, driving the delivery of innovative technology solutions that enhance business outcomes. Areas of focus will be on leading team performance, delivery management, and facilitating continuous improvement in both technical skills and user experience. Roles & Responsibilities: Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs Lead the day-to-day operations and maintenance of Pharmacovigilance (PV) systems. Overall accountability of technical implementation aspects of projects including planning, architecture, design, development, and testing to follow IS Change Control and GxP validation process. Provide support and consultation to clients or project teams to identify requirements and assist with application configurations and deployments. Monitor operational and performance statistics for managed systems to ensure reliability and availability. Oversee production change control schedule and participates in change control processes. Stay updated on industry trends, emerging trends and standard processes for PV systems. Maintain knowledge of trends in application development frameworks and related new technologies to provide, recommend, and deliver standard methodology solutions. Basic Qualifications and Experience: Master’s / Bachelor's degree with 5-9 years of experience in Computer Science, Software Development, IT or related field Functional Skills: Must-Have Skills: Experienced in database programming languages, data modelling concepts, including Oracle SQL and PL/SQL. Excellent problem-solving skills. Collaborative spirit and effective communication skills to seamlessly work in a cross-functional team. Hands-on experience with the ITIL framework. Good-to-Have Skills: Experience with API integrations such as MuleSoft, Data Bricks platforms Knowledge of Artificial Intelligence (AI), Robotic Process Automation (RPA), Machine Learning (ML), Natural Language Processing (NLP) and Natural Language Generation (NLG) automation technologies with building business requirements. Experienced in managing GxP systems and implementing GxP projects Extensive experience with Software Development Lifecycle (SDLC). Ability to explain technical concepts to non-technical clients Professional Certifications: SAFe® for Teams certification (preferred) Soft Skills: Excellent analytical and problem-solving skills Excellent leadership and critical thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Ability to deal with ambiguity and prioritize Ability to influence and drive to an intended outcome Ability to hold team members accountable to commitments Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

Job title: Expert Quality Services (Product Complaints) Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main responsibilities: Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. About you: Experience: 6 – 10 years of related experience in the pharmaceutical industry. Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. Languages: Verbal and written fluency in English Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. Mousim Shaikh , Lead Quality Services (Product Complaints) Pursue Progress . Discover Extraordinary . Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue Progress. And let’s discover Extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Job Description The Medical Information Admin Assistant provides comprehensive administrative support to the Medical Information (MI) Enquiry Handling teams and Senior Management in an accurate and efficient manner. Responsibilities General administrative duties as delegated by management. Answering the main telephone line of the Company in a professional manner and transferring calls as appropriate. On an ad-hoc basis providing reception cover which includes meeting, greeting, and signing in all visitors to the ProPharma office in a friendly, courteous, and professional manner. Supporting the filing clerks, including opening the daily mail received into the company, franking, and posting the mail, filing, archiving and checking stationery stocks. Effectively perform in at least three task areas. Quality Assurance Maintaining a good level of quality in all aspects of the job. Complying with the procedures documented in the Company Standard Operating Procedures (SOPs) and Working Instructions (WIs). General Having a solid working knowledge of, and complying with, the Standard Operating Procedures of ProPharma Working in a professional manner at all times, with clients, customers, team members and management. Complying with the Company’s Health and Safety Policies. Ensuring the Confidentiality Statement within the Contract of Employment is always adhered to in respect of the data and property of ProPharma, its clients and employees of the business. Ensuring that any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations as described in ProPharma SOPs. Other duties as assigned. Necessary Skills And Abilities Able to work within a team in a professional manner. Sound written and oral communication skills. Good accuracy and attention to detail skills. Solid level of productivity on all tasks. Sound organizational and prioritizing skills showing an effective workload management system. Able to understand and follow processes. Pleasant and professional telephone manner. Computer literacy (MS Office). We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Preparation, review, and approval of investigation reports, risk assessment, impact assessment reports, and other required documents are key responsibilities in this role. You will handle product quality complaints (Adverse Event) related to Pharmacovigilance and market complaint investigations in CHEX system as per procedures, in coordination with the Pharmacovigilance team for adverse events. Additionally, you will manage the ENSUR system for the issuance and retrieval of SOPs, specifications, ATRs, worksheets, stability protocol management, BMR, BPR, BFR, as required. Ensuring document control, archival, retention, and destruction as defined in the procedure is crucial. You will also manage master and obsolete copies for SOPs, specifications, ATRs, worksheets, stability protocols, BMR, BFR, BPR, etc., and track SOPs, procedures, and specifications for revision as per the validity period. Archival management responsibilities include archival and retrieval of documents as needed. Your role will involve reviewing quality system documents such as protocols, reports, procedures, APQR, trend analysis reports, continual process verification reports, and sharing these documents with the RA department for filing updation based on change control implementation. Additionally, you will prepare and review customer and external audit compliance reports, as well as review and approve analytical reports like batch analysis, standards, stability studies, etc., and perform GMP verification and compliance reviews. To comply with safety, health, and environment guidelines, you must follow SHE Guidelines, SHE Rules, and Regulations, and use PPE wherever applicable. The qualifications required for this position include a Bachelor's Degree in Pharmacy/B.Sc/M.Sc/B.Tech in Chemical. In the three decades of its existence, Piramal Group has pursued a strategy of both organic and inorganic growth. Driven by core values, Piramal Group focuses on inclusive growth and ethical practices. Equal employment opportunity is a priority, where decisions are based on merit, qualifications, skills, performance, and achievements, ensuring equal opportunities for all. Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), is committed to delivering critical care solutions globally. PCC maintains a wide presence across the USA, Europe, and more than 100 countries worldwide, with a rich product portfolio that includes Inhalation Anaesthetics and Intrathecal Baclofen therapy. The team at PCC is dedicated to sustainable growth, with a global workforce spread across 16 countries, focused on expanding the global footprint through new product additions in the critical care space. Corporate social responsibility is a key focus, with collaborations and active roles in providing hope, resources, and care for the environment.,

Job Description: As a Drug Safety Physician at ICON, you will play a crucial role in providing medical and safety support to the activities of ICON Project Teams. Your primary responsibility will be to ensure that projects are conducted in adherence to the highest ethical principles and medical standards, following Good Clinical Practice (GCP) and good pharmacovigilance practices, and in compliance with applicable legal and regulatory standards. Your key responsibilities will include reviewing and accurately assessing Adverse Events (AEs) and Adverse Drug Reactions (ADRs) in terms of seriousness, expectedness, listedness, and relatedness using coding such as MedDRA. You will also be responsible for reviewing aggregated reports, providing safety profile assessments, identifying safety issues in clinical trials or post-marketing settings, and escalating them to the appropriate channels within ICON for resolution with the client. Additionally, you will be involved in providing support and training on regulatory requirements for expedited and periodic reporting of AEs/ADRs, participating in project-related meetings, communicating with the client as per the Project Specific Procedures, assisting in code-break activities, reviewing and providing input to product information, and offering pharmacovigilance consultancy to clients regarding regulatory reporting requirements. Furthermore, you will provide guidance to Medical and Safety Services staff on regulatory reporting of adverse events and undertake any other responsibilities as assigned. Your role will require collaboration, communication, and a commitment to upholding the highest standards of patient safety and regulatory compliance. Role requirements: To be successful in this role, you should be a qualified and licensed physician with 2-3 years of patient diagnosis and treatment experience in a hospital-based setup. Prior experience in clinical research or pharmacovigilance is optional but beneficial for this position. Benefits of Working in ICON: At ICON, we value our people and strive to create a culture that rewards high performance and fosters talent development. We offer competitive salary packages that are regularly benchmarked against industry standards, with annual bonuses tied to performance goals for both the organization and individuals. In addition to competitive salaries, we provide a range of health-related benefits for employees and their families, as well as comprehensive retirement plans and life assurance to support long-term financial planning. Our work environment encourages individuals to pursue their sense of purpose and drive meaningful change, contributing to a fulfilling career at ICON. What ICON can offer you: In addition to competitive compensation, ICON provides a variety of benefits tailored to support employee well-being and work-life balance. These benefits include various annual leave entitlements, diverse health insurance options, retirement planning offerings, and a Global Employee Assistance Programme for 24-hour access to specialized professionals for support. We also offer life assurance and country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, and health assessments to promote employee well-being. At ICON, we are committed to diversity, inclusion, and supporting our employees in achieving their personal and professional goals. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please inform us so we can assist you accordingly. Interested in joining ICON but unsure if you meet all the requirements We encourage you to apply regardless, as your unique skills and experiences may align with our needs for this role or other opportunities within the organization. At ICON, we are always looking for talented individuals who share our vision and values.,

As a Training Specialist at Fusion Technology Solutions, you will be responsible for conducting both in-person and virtual training sessions, workshops, and seminars focusing on various aspects of clinical research processes. This includes training sessions on Good Clinical Practice (GCP), ethical guidelines, safety reporting, and trial protocols. Additionally, you will be tasked with creating and updating curriculum, training materials, and e-learning content specifically designed for clinical research personnel. Your role will also involve delivering sessions covering clinical research, clinical data management, pharmacovigilance, and medical coding. Fusion Technology Solutions is a leading skill development training institute that offers a diverse range of courses across multiple industry sectors. In the healthcare/medical domain, we specialize in providing training for clinical research, medical coding, and pharmacovigilance. Our comprehensive training programs extend to other sectors such as aviation, IT, research, and marketing, offering a wide array of courses tailored to meet the evolving needs of professionals seeking to enhance their skills and expertise.,

Job title: Expert Quality Services (Product Complaints) Location: Hyderabad About The Job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main Responsibilities Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. About You Experience: 6 – 10 years of related experience in the pharmaceutical industry. Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. Languages: Verbal and written fluency in English Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. Mousim Shaikh , Lead Quality Services (Product Complaints) Pursue Progress . Discover Extraordinary . Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Job title: Specialist Quality Services (Product Complaints) Location: Hyderabad About The Job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main Responsibilities Receipt of inquiry, classify/Validate as PTC/Non-PTC. Categorize Product Technical Complaint (PTC) based on its potential impact on product quality or patient safety as per defined timelines. Recording of complaint details in global system including defective quantity / verify lot number. Categorize and process the Fast track complaint based on defined criteria. Sample management- request for sample collection, update sample/picture information in global system Act as a regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management. Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site. Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Consulting to FAR team in case of any filed alert expected (as applicable). About You Experience: 2 – 6 years of related experience in the pharmaceutical industry. Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering. Languages: Verbal and written fluency in English Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Our Team Sanofi's Saath 7 is a structured patient support program designed to enhance diabetes management after patients are prescribed Sanofi’s product. The initiative focuses on providing patient education, and defined patient support to improve patient outcomes. Main Responsibilities Program Implementation and Execution: Execute and oversee PP operations in alignment with organizational SOPs, code of conduct, compliance frameworks and country regulations. Develop and drive regional strategies to optimize patient enrollment, adherence, and overall program efficiency. Ensure seamless coordination with third-party service providers to deliver quality patient support. Regularly evaluate program impact and implement necessary improvements. Report to the Sanofi PP Head/PP Manager and they are regionally based. Serve as the primary point of contact for patient support initiatives in the region, ensuring seamless delivery of services to enhance patient experience and outcomes. Manages Dry Blood Spot (DBS) requests within the Diagnostic Support Program including e-consent processes, oversees High Risk Testing projects ensuring compliance with SOPs and local requirements, while continuously improving processes and providing physician support. Patient Interaction And Support Oversee the PP service provider's patient support, ensuring timely and effective support. Guide counselors in delivering disease education, medication adherence information, and lifestyle modifications as permissible. Foster smooth communication between patients, caregivers, and healthcare professionals to enhance patient experience and adherence. Coordinate patient programs across multiple therapy areas, ensuring consistent implementation of support services and adherence to protocols. Stakeholder Management Establish and nurture partnerships with key stakeholders, including HCPs, to enhance program reach and credibility. Work cross-functionally with internal teams (e.g., medical team, PP Head, PPL manager, Regulatory, PV) and PP service provider to ensure regulatory compliance and program alignment with medical and quality standards. Operational Management Supervise aggregate data tracking and ensure comprehensive reporting in line with compliance mandates. Contribute to PP enhancements by identifying gaps and proposing innovative solutions to strengthen patient engagement and support services. Pharmacovigilance & PTC Reporting Monitor and enforce adherence to Pharmacovigilance (PV) and Product Technical Complaint (PTC) reporting protocols. Ensure that all adverse events and quality concerns are reported promptly and managed in compliance with Sanofi's regulatory and safety guidelines. Work closely with PP service provider to uphold quality standards and maintain program integrity. Ensure all Adverse Events (AEs) are reported to the Sanofi Pharmacovigilance Team within 1 working day. Ensure PTC reports are submitted to the Country Quality Team within 1 working day. Work with third-party providers to maintain data accuracy and compliance with SOPs. Compliance Ensure strict adherence to compliance standards governing PP activities under the guidance of PP Head and PPL Manager. Enforce patient engagement protocols that align with SOPs, data privacy guidelines, and regulatory requirements. Train and oversee PP teams to ensure ethical and compliant execution of program activities. Data Privacy Compliance: PP Coordinators must not handle patient data, per the SOP for Data Privacy Compliance. Patient data must be managed by third-party providers, ensuring compliance with DPDPA and Sanofi’s internal privacy policies. No unauthorized data access or sharing by Sanofi employees, maintaining strict compliance with regulatory requirements. About You Overall Experience: 3-5+ years of working in pharma industry/healthcare industry is preferred Previous experience in patient support program in pharmaceutical industry, or healthcare setting would be an added advantage Knowledge: Strong understanding of patient support programs, pharmaceutical regulations, and healthcare systems. Communication and presentation skills Coaching Skill Interpersonal relations and skills to manage customer relations. Team handling experience is preferred Soft Skill- Knowledge of Computer applications (MS office) esp. Excel & PowerPoint Ability to work with huge database. Technical skills: Product knowledge/Market Knowledge. Education: Graduate in Science/Pharmacy/Social Work Languages: English Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration Medical device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Office cab/shuttle Annual bonus Health insurance Provident fund

Job title: Specialist Quality Services (Product Complaints) Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main responsibilities: Receipt of inquiry, classify/Validate as PTC/Non-PTC. Categorize Product Technical Complaint (PTC) based on its potential impact on product quality or patient safety as per defined timelines. Recording of complaint details in global system including defective quantity / verify lot number. Categorize and process the Fast track complaint based on defined criteria. Sample management- request for sample collection, update sample/picture information in global system Act as a regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management. Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site. Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Consulting to FAR team in case of any filed alert expected (as applicable). About you: Experience: 2 6 years of related experience in the pharmaceutical industry. Knowledge of cGMP s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor s or Masters in Life Sciences/Healthcare, Business Administration, Engineering. Languages: Verbal and written fluency in English Why choose us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.

KIRTI PHARMACEUTICALS is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

PV Reporting Associate We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization s commitment to patient safety and compliance. What You Will Be Doing: Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re 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 or submit a request here . Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

PV Reporting Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization s commitment to patient safety and compliance. What You Will Be Doing: Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. What ICON can offer you: Our success depends on the quality of our people. That s why we ve 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 family s needs. Competitive retirement planning offerings to maximize 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 family s 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. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles.

Job Overview Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff. Essential Functions Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events database entry coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan. Perform activities related to adjudication as applicable Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting. Liaise with manager for regulatory tracking requirements and electronic reporting. Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate. Ensure to meet quality, productivity and delivery standards per project requirements. Ensure compliance to all project related processes and activities. Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed. Provide and impart technical and process information to Safety Management and members of operational team on project specific issues. Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives. Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement. Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes effective feedback on project performance to junior members of team. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring completeness of individual training plan and maintain up to date training transcripts. Participate or Lead trainings across Safety process service offerings participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies. To demonstrate problem solving capabilities. Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues. Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes. To liaise with client in relation to details on day to day activities as needed. Contribute to achievement of departmental goals Perform other duties as assigned 100% compliance towards all people practices and processes In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications. Qualifications Bachelors Degree Scientific or healthcare discipline or allied life sciences Req Bachelors degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience. Req or equivalent combination of education, training and experience. Pref Excellent knowledge of medical terminology. Intermediate In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications. Advanced In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements. Advanced Excellent organizational skills, time management skills, attention to detail and accuracy. Advanced maintain high quality standards. Advanced Excellent working knowledge of Microsoft Office and web-based applications. Intermediate To demonstrate effective project management and leadership skills. Intermediate Effective mentoring and coaching skills. Advanced Excellent verbal/written communication skills. Advanced Self-motivated, flexible, receptive to changing process demands. Advanced willingness and aptitude to learn new skills across Safety service lines. Advanced Proven ability to work independently and autonomously with policies and practices. Advanced Proven ability to multi-task, meet strict deadlines, manage competing priorities. Advanced Ability to identify, prioritize tasks and delegate to team members. Advanced Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Advanced Ability to work as a Team Player, contribute and work towards achieving Team goals. Advanced Demonstrate Sound judgment and decision making skills. Advanced Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams priorities. Intermediate Ensure quality of deliverables according to the agreed terms. Advanced Demonstration of IQVIA core values while doing daily tasks. Advanced Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations. Intermediate Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders. Intermediate Support audit preparedness Advanced Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate Regular sitting for extended periods of time. Intermediate May require occasional travel. Intermediate Flexibility to operate in shifts. Advanced 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 Let s stay connected. 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ProductLife Group is looking for Medical Reviewers, having 3-4 years of experience with MBBS/MD degree. Responsibilities: We are looking for a medical reviewer proficient in post-marketing drug safety. Post-Marketing (Pharmacovigilance) Medical review of the ICSRs (Spontaneous, literature, clinical studies) Support in seriousness assessment, Initial Triage Support in causality, medical assessment, benefit-risk evaluation of the medicinal product. perform additional review of cases to ensure competency. Participate in audits and inspections as required Ensure understanding of client needs, conventions and ensure expectations are met and exceeded Training and mentoring other team members on good assessment of the cases and MedDRA coding Required Education: MBBS, or MD (Doctor of Medicine) Required Experience: Client communications Safety Database experience Minimum 3-4 years experience working for service providers or pharmaceutical company in Pharmacovigilance department Additional experience and/or skills:: Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team. Clinical experience an advantage Ability to deliver constructive feedback Emotional intelligence Adaptability Analytical skills Flexibility Reliable Strong organisation skills Punctual Database experience

Jd Serve as the company’s subject matter expert on drug safety and pharmacovigilance Ensure compliance with Local & Global PV-relevant Heath Authority requirements Oversee PV Contracts, vendor management and PV system audits/inspections Have good understanding of signal management and benefit-risk evaluation activities Develop and implement Risk Management Plans (RMPs) and additional Risk mitigation measures Act as the primary safety liaison with country regulatory authorities and internal stakeholders Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance, marketing teams etc. Contribute to clinical trial safety strategies and protocols (e.g., protocols, safety monitoring plans, SAE reporting etc.) Mentor and develop PV team members to maintain a culture of continuous improvement and compliance Manage departmental budgets, staffing, and resourcing in line with organizational needs Qualifications Advanced degree in Medicine or Pharmacy Minimum 10 years of progressive pharmacovigilance experience in the pharmaceutical industry In-depth understanding of Local/global PV regulations and guidance Demonstrated experience in leadership roles with proven ability to build and scale PV systems. Strong analytical, strategic thinking, and communication skills.

Coordinate and manage clinical trials from initiation to completion, ensuring compliance with regulatory guidelines and study protocols Recruit, screen, and enroll study participants while maintaining accurate documentation and records Required Candidate profile Maintain study supplies, track data collection, and support data analysis, ensuring high-quality and ethical research practices throughout the study

Clin Infotech is offering the internship opportunity for BDS MDS Dental Graduates Should have Knowledge in Pharmacovigilance Should Have knowledge on Argus & MEDDRA Applicants Should Complete Certification in Pharmacovigilance 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

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.

Clin Infotech is offering internship Opportunities for B.Pharm and M.Pharm Freshers who are willing to start a career in Clinical Research Pharmacovigilance clinical data management sas Medical writing and Medical coding Required Candidate profile Clinical Research Internship includes of Hands on Experience on softwares in Clinical Research Pharmacovigilance clinical data management Domain. B.Pharm M.Pharm and Pharm D Are Eligible to Apply

Job title: Specialist Quality Services (Product Complaints) Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main responsibilities: Receipt of inquiry, classify/Validate as PTC/Non-PTC. Categorize Product Technical Complaint (PTC) based on its potential impact on product quality or patient safety as per defined timelines. Recording of complaint details in global system including defective quantity / verify lot number. Categorize and process the Fast track complaint based on defined criteria. Sample management- request for sample collection, update sample/picture information in global system Act as a regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management. Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site. Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Consulting to FAR team in case of any filed alert expected (as applicable). About you: Experience: 2 – 6 years of related experience in the pharmaceutical industry. Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering. Languages: Verbal and written fluency in English Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.

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.

Urgent Walk in For M.Pharmacy fresher Completed Clinical Data Management Training only Eligible CDM Certification is Mandatory Knowledge of Clinical Data Management Plan, study phase conduct phase and Close out phase Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.

Manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. Conducts research to ensure these products are safe. Ordering, tracking, and managing IP and trial materials. Required Candidate profile Knowledge of the pharmaceutical industry, terminology, and practices. - Knowledge of FDA regulations and their practical implementation. - Strong verbal and written communication skills.