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1.0 - 3.0 years
3 - 7 Lacs
Bengaluru
Work from Office
About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft WordBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Good Communication Skills Roles and Responsibilities: Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Qualification Any Graduation
Posted 3 weeks ago
1.0 - 3.0 years
3 - 7 Lacs
Navi Mumbai
Work from Office
About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) Operations Roles and Responsibilities: Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Qualification Any Graduation
Posted 3 weeks ago
3.0 - 5.0 years
4 - 9 Lacs
Chennai
Work from Office
In this pharmacovigilance role, you will carry out processing activities of Individual Case Safety Reports (both clinical trials and post-marketing sources) in the ARGUS Safety database. Processing activities include assessing case validity, undertaking duplicate checks, creating cases in the database, prioritizing cases as per company guidance, updating cases with information provided in XML source documents, identifying adverse events, confirming their seriousness, coding products, undertaking causality and listedness assessments, drafting narratives, determining appropriate case follow-up, reviewing processed cases to verify technical judgment, accuracy, and compliance with company requirements, etc. Here Is What You Need (Minimum Requirements): Education = B. Pharm, M. Pharm, or Pharm. D only. Minimum experience = 1 year. Maximum = 2 years. End-to-end ICSR processing, including labeling assessments. Good knowledge of medical terminology and global regulatory requirements for drug safety. Keen attention to detail. Solid analytical skills. Good written and oral communication skills. Collaborative skills. Continuous Learning. Bonus Points If You Have (Preferred Requirements): Hands-on experience in the ARGUS safety database. Proficiency with processing source documents in XML format (E2B R2 and R3). Course completion and/or certification in Pharmacovigilance. Publications in peer reviewed journals. Work Location Assignment: Hybrid Medical #LI-PFE
Posted 3 weeks ago
3.0 - 7.0 years
14 - 19 Lacs
Hyderabad
Work from Office
Summary -Monitors and audits the company s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing. About the Role Major accountabilities: Global and /or regional, cross-functional leadership of assigned pharmacovigilance processes across Novartis
Posted 3 weeks ago
1.0 - 3.0 years
3 - 7 Lacs
Gurugram
Work from Office
About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Business and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Good Communication Skills Roles and Responsibilities: Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Qualification Any Graduation
Posted 3 weeks ago
5.0 - 8.0 years
4 - 8 Lacs
Bengaluru
Work from Office
About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The clinical automation team focuses on the development and implementation of innovative concepts and application for our client across different accounts in operations. The team is responsible for designing and implementing highly interactive scalable web apps and prototypes at enterprise level.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, Python, Full- Stack Developer. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamBachelors degree in Computer Science, Information Technology, Engineering or any computer related discipline.Work experience of at least 3 year in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.).Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions.Work experience in Implementing APIs based architecture frameworks.Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment.Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations.Design and implement highly interactive, scalable web apps and prototypes at Enterprise level.Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly.Implement APIs based on architecture frameworks and guidelines.Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines.Able to lead Automation initiatives within his account.Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution.Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain.Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You should be able to pilot and deploy automation solutions at scale.Partner with the testing team to ensure applications/components are fully functional.Oversee and fix any defects or performance problems discovered in testing.Participating in analyses of requirements as well as functional design whenever necessary.Be involved in the design of the solution.Performing design, coding, application maintenance and testing activities.Take ownership of the successful implementation of the solution. Qualification BE,BTech,MCA
Posted 3 weeks ago
0.0 - 2.0 years
4 - 8 Lacs
Chennai
Work from Office
About The Role Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 2 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Agility for quick learningAbility to work well in a teamAdaptable and flexible Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification MBBS
Posted 3 weeks ago
5.0 - 10.0 years
8 - 12 Lacs
Bengaluru
Work from Office
Purpose: The Global Patient Safety (GPS) organization is responsible for delivering scientific, medical and pharmacovigilance expertise in support of Lilly s products in development as well as for marketed medicines and devices globally. The Clinical Surveillance Scientist leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders is an important capability for this role. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Signal Detection and Safety Data Evaluation Drive the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile and consult and collaborate with other safety personnel as appropriate. Develop and review label changes and labelling modifications in collaboration with teams, regulatory and legal. Apply effective communication skills to lead and facilitate safety team meetings for compounds in clinical development and marketed products Define data acquisition strategy, methodology, and approach for safety evaluations. Perform analysis of safety data and lead authoring of safety topic reports Collaborate with GPS Medical physicians, scientists, pharmacoepidemiologists, and other personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner. Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions Risk Assessment, Regulatory Inquiries, and Periodic Reporting Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs) Provide input to safety communications in the form of labeling, medical information inquiries, and healthcare professional (HCP) letters Promote and Advance the Field of Pharmacovigilance Responsible for effective communication and influence with internal Lilly customers (e.g. medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies) Accelerate the advancement of and contribute to the development and coaching of peers and less experienced employees Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity Effectively function and communicate as part of inclusive cross functional teams (e.g. GPS Medical physicians and scientists, Pharmacoepidemiologists, Research and Business Unit team members, other safety personnel) that foster trust, respect, and accountability Demonstrate and apply pharmacovigilance knowledge, including the role of the QPPV, to ensure compliance with local laws and regulations Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with local laws and regulations Minimum Qualification Requirements: Advanced medical related graduate degree, such as: pharmacy (PharmD), nursing with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner), PhD with 1-3 years experience in related scientific field, e.g. pharmacology, physiology, microbiology or scientifically related field. OR BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs. OR 3-5 years of clinical experience or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience Other Information/Additional Preferences: Clinical knowledge of various disease states, drug effects, human physiology and pharmacology Experience within Global Patient Safety or demonstrated understanding of Pharmacovigilance is preferred Demonstrated ability to manage multiple deliverables simultaneously Lilly 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. . .
Posted 3 weeks ago
5.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Department – Rare Disease - Marketing- Early Launches Location - Hyderabad Novo Nordisk India Private Limited Are you an experienced medical professional and passionate about Clinical Medical? Does being part of a growing, yet dynamic environment excite you? If yes, then you may be the one we are looking for as Clinical Medical Manager for Novo Nordisk India. Apply now! The position As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research center’s within the relevant therapy areas. Collect early scientific insights and guidance by discussing relevant early development data with external medical and scientific experts. Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations. Provide timely medical guidance and internal training to clinical staff. Engage in extensive scientific communication both internally and externally, requiring strong presentation skills. Performing ad hoc visits, Supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials and engaging key investigators to communicate trial results. Qualifications To be successful in this role, you should have the following qualifications: MD in any discipline with a strong clinical research/medical affairs background. 5 years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs, or pharmaceutical industry. Expertise in therapeutic areas of relevance (CVD, CKD, NASH), preferably with authorship in peer-reviewed journals. Understanding of pharmaceutical drug development. Open to domestic and international travel in connection with site visits, congresses, and company events. Experience as a clinical trial investigator or sub-investigator. Understanding the specificities and nuances of the local healthcare infrastructure. About The Department The CMR (Clinical, Medical, Regulatory & Pharmacovigilance) team based in Bangalore. Our team is dedicated to driving clinical trials and providing medical/scientific expertise in New Therapy Areas. We work closely with KOLs, independent professional associations, and patient advocacy associations to ensure the successful execution of clinical trials. The atmosphere is collaborative and dynamic, with a strong focus on scientific excellence and patient outcomes. Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Managers before applying. Deadline 20th July 2025 Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Posted 3 weeks ago
0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force . We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below. Medical Reviewer You will be responsible for : PRINCIPAL RESPONSIBILITIES: Responsible for medical review of ICSRs for accuracy, medical relevance, and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement Evaluate adverse events (AE) report for seriousness, listedness and ensures that all medically relevant information from the source documents is included Assessment of reported AE and serious adverse events (SAE) providing company causality assessment utilizing clinical and global introspection methodologies aligned with global regulations. Reviews the case narrative, coding, product/Indication, labeling in accordance with the respective reference safety documents, causality and medical history for medical completeness, accuracy, and overall medical content. Provide medical sign off on the case. Perform line listing review of non-serious cases and evaluates the coding and labelling and confirm the events are evaluated correctly Perform unblinding activities as applicable Ensure appropriate follow-up questions/questionnaires are sent out based on the case. Perform Literature Surveillance when required Medical review of Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, and literature review Tracking of inconsistencies on activities performed by data entry and QC reviewer as per the checklist and provide unbiased feedback, suggestions, points of improvement for attaining quality standards as per client expectations Responsible for following international pharmacovigilance regulations, company and department SOPs and department and function working practices. Contribute to pharmacovigilance and risk management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues. Review safety assessments, risk/benefits evaluations, provide inputs and value add from medical perspective at all stages of safety Review, author and update standard operating procedures (SOP) and support in global initiatives for ensuring enhanced quality and compliance Communicate the observations to the applicable stakeholders and ensure the appropriate root cause analysis (RCA)/corrective action and preventive action (CAPA) Ensures follow up information is requested on relevant reports Present QA data to the responsible internal stakeholders in an appropriate forum as required Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines Attend all the Governance and team meetings as required and appropriate Qualification : MBBS is required ( MCI registration is mandatory ) Your impact: About you: Must have: Cognitive abilities including verbal reasoning, attention to detail, critical thinking, scientific accuracy, and analytical ability. Ability to understand the purpose and requirements of a project. Good comprehension skills. Good communication and interpersonal skills. Drive quality and ensure team meets deadlines and commitments. Excellent mentoring and training skills. Knowledge of disease pathology and physiology, pharmacology and therapeutics. Familiarity with pharmaceutical industry principles of drug development and pharmacovigilance is preferred but not required. Very good understanding and track record in pharmacovigilance that can be applied and executed. Sound knowledge in pharmacovigilance safety database and compliance activities. EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
Posted 3 weeks ago
0 years
0 Lacs
Pune, Maharashtra, India
On-site
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description POSITION SUMMARY The Client Quality Assistant supports the Client Quality team with administrative tasks, including but not limited to tracking, document preparation, compliance assessment and project planning. The Client Quality Assistant supports the Client Quality team in ensuring that its activities are managed in compliance with global regulations, legislation and PrimeVigilance requirements. Drives quality and compliance by ensuring tracking of completion of key quality tasks for projects. Role And Responsibilities Key responsibilities include (but are not limited to): Document organisation Data retrieval and tracking for different purposes Conduct periodic training reconciliation and maintenance of training matrix Generate metrics and KPI assessment Prepare documents´ drafts and/or final lay out, as applicable Organise meetings and teleconferences Assist with the organisation of Client Quality department Perform other miscellaneous administrative tasks, as applicable Assistance with preparation of documents for audit/inspection requests Specified Additional Responsibilities Other administrative support as required. The Client Quality Assistant will support the PrimeVigilance Senior Leadership team and the Associate Director of Quality with assigned quality related projects and responsibilities. Qualifications University graduate Advanced English (both spoken and written) Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint 2-3 yrs of experience in an administrative position involving management and creation of reports Strong communication skills, attention to detail and problem-solving abilities Additional Information We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We Offer Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application!
Posted 3 weeks ago
0.0 - 6.0 years
0 Lacs
Bengaluru, Karnataka
On-site
Safety Operations Specialist I Category: Reg Affairs & Safety Pharmacovigilance Location: Bangalore, Karnataka, IN Department : Global Patient Safety – Global Business Services. Are you passionate about ensuring the safety of medicinal products? Do you have extensive experience in pharmacovigilance and regulatory compliance? If so, you might be the perfect fit for our Safety Operations Specialist I position! Read more and apply today for a life-changing career. Job Level : 7 The position A Safety Operations Specialist I at Novo Nordisk should Establish new or improved methods of working within your field of expertise by sharing best practices and ensuring consistency in safety deliverables. Act as a competent partner to the line of business by providing qualified support in relation to quality, processes, products, organization, and corporate business objectives. Handle adverse events and other safety information, ensuring fulfilment of global regulatory requirements. Lead projects across functional areas by defining project scope, goals, expected deliverables, and stakeholder mapping. Act as a deviation and change request owner, preparing deviation and change reports, facilitating root cause investigations, and driving decision-making on corrective/preventive actions. Review safety data presented in relation to audits and inspections, and present global safety processes within C2.01 in global audits and inspections. Collaborate with affiliates to support the implementation of new processes and/or requirements based on increased regulatory demands. Q ualifications Graduation and/or post-graduation in life sciences. Minimum of 6 years of relevant working experience within pharmacovigilance. Extensive knowledge of pharmacovigilance principles and business processes required for the efficient handling of safety information. Experience in providing training and support in a professional context. In-depth understanding of Novo Nordisk’s organization and/or pharmaceutical company operations. Extensive experience in studying scientific regulations/guidelines. Extensive knowledge and understanding of GxP requirements. Experience working with business process improvements. Experience working in international and diverse professional groups. Fluency in English, both written and spoken. About the department Global Patient Safety - Global Business Services (GPS-GBS) was set up in 2010 as one of the hubs for safety case processing. At GPS-GBS, we handle case processing from different sources including spontaneous, literature, solicited, and clinical trials. Apart from complete case processing and medical review, GPS-GBS is also engaged in safety report submission, training, LearnIt administration, quality control of individual case safety reports (ICSR), ARGUS configuration and maintenance, information technology quality assurance, training coordination, and literature surveillance activities, including medical literature monitoring. Wor king at Novo Nordisk Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing. Contact To submit your application, please upload your CV online (click on Apply and follow the instructions). Deadline 17th July 2025. Disclaimer It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Posted 3 weeks ago
1.0 years
0 Lacs
Chennai, Tamil Nadu, India
On-site
In this pharmacovigilance role, you will carry out processing activities of Individual Case Safety Reports (both clinical trials and post-marketing sources) in the ARGUS Safety database. Processing activities include assessing case validity, undertaking duplicate checks, creating cases in the database, prioritizing cases as per company guidance, updating cases with information provided in XML source documents, identifying adverse events, confirming their seriousness, coding products, undertaking causality and listedness assessments, drafting narratives, determining appropriate case follow-up, reviewing processed cases to verify technical judgment, accuracy, and compliance with company requirements, etc. Here Is What You Need (Minimum Requirements): Education = B. Pharm, M. Pharm, or Pharm. D only. Minimum experience = 1 year. Maximum = 2 years. End-to-end ICSR processing, including labeling assessments. Good knowledge of medical terminology and global regulatory requirements for drug safety. Keen attention to detail. Solid analytical skills. Good written and oral communication skills. Collaborative skills. Continuous Learning. Bonus Points If You Have (Preferred Requirements): Hands-on experience in the ARGUS safety database. Proficiency with processing source documents in XML format (E2B R2 and R3). Course completion and/or certification in Pharmacovigilance. Publications in peer reviewed journals. Work Location Assignment: Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical
Posted 3 weeks ago
2.0 - 5.0 years
3 - 4 Lacs
Dakshin Dinajpur
Work from Office
Jeevan Rekha Hospital 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.
Posted 3 weeks ago
2.0 - 5.0 years
6 - 7 Lacs
Chennai
Work from Office
Pharmacovigilance 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 Job Description Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within project specified timelines. Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines in accordance with company procedures. Maintain a strong understanding of ICONs safety reporting systems, processes, and conventions, as appropriate. Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting. Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements. Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects. Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations. Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated. Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable. Build and maintain good relationships across functional units. Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases. Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections. Prepare for and represent the department in audits and inspections as designated. Review regulatory and safety reporting intelligence to keep updated on current regulations, practices, procedures, and proposals as assigned. Coach and mentor less experienced associates in safety reporting or safety reporting intelligence activities and other work, as needed. Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned. Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects, as designated. Maintain understanding of applicable therapeutic areas and disease states as required. Travel (approximately 10%) domestic and/or international, as required. Perform other activities as identified and requested by management. 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. 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 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. Are you a current ICON Employee? Please click here to apply
Posted 3 weeks ago
2.0 - 5.0 years
6 - 7 Lacs
Chennai
Work from Office
Pharmacovigilance Reporting Associate Job Description Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within project specified timelines. Release of safety reporting intelligence for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines in accordance with company procedures. Maintain a strong understanding of ICONs safety reporting systems, processes, and conventions, as appropriate. Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting. Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements. Operate in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects. Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations. Serve as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated. Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable. Build and maintain good relationships across functional units. Work within multiple databases. Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases. Perform filing and quality control of documents submitted to the eTMF or agreed filing solution ensuring file readiness on assigned projects for audits or inspections. Prepare for and represent the department in audits and inspections as designated. Review regulatory and safety reporting intelligence to keep updated on current regulations, practices, procedures, and proposals as assigned. Coach and mentor less experienced associates in safety reporting or safety reporting intelligence activities and other work, as needed. Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned. Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects, as designated. Maintain understanding of applicable therapeutic areas and disease states as required. Travel (approximately 10%) domestic and/or international, as required. Perform other activities as identified and requested by management. 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 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. Are you a current ICON Employee? Please click here to apply
Posted 3 weeks ago
7.0 years
14 - 16 Lacs
Hyderabad
Work from Office
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Data Acquisition Specialist Min 5 + yrs of experience in Data Acquisition domain. Expertise in Handling Non-CRF activities, able to work autonomously on the non-CRF data strategy. In-depth understanding of Data Management conventions, data standards, Processes and Drug development Process. Experience with Study convention including non-CRF collection data standards, Processes, Knowledge sharing and best practices on assigned studies. Influence Study Team to adhere non-CRF guidance, processes and negotiate contingency plans to mitigate delays of deliverables. Task: Lead collection of non-CRF data during Study Setup, Conduct and Closeout activities IXRS and Complex Data Models. Effectively communicate non-CRF data collection deliverable, Status of work and Data issues to the assigned study team and SME’s. Collaborate with multiple non-CRF vendors or data providers to setup Data Transfer Agreement to ensure timely and quality delivery.
Posted 3 weeks ago
3.0 - 8.0 years
14 - 19 Lacs
Mumbai
Work from Office
: Job Title CSO Environmental and Social Due Diligence & Sustainable Finance Manager LocationMumbai, India Corporate TitleAS Role Description The Chief Sustainability Office is responsible for developing Deutsche Banks sustainability strategy and driving its implementation across all business divisions, infrastructure functions, and regions. Its core responsibilities include defining the strategic framework, coordinating the Banks sustainable finance activities, setting ESG standards, and overseeing regulatory and disclosure obligations. It comprises four teams: Strategy & Regional Governance , Execution, Data & Regulatory , Group Sustainability , and ESG Transparency . Strategy & Regional Governance develops and coordinates the Groups sustainability strategy and governance. It supports the business divisions and cross-divisional business opportunities and coordinates the planning of the Banks Sustainable Finance targets. Execution, Data & Regulatory is responsible for implementing the Banks strategic sustainability objectives through the Sustainability Key Deliverable (KD) and also covers centrally managed non-KD implementation projects with an ESG nexus. In addition, it identifies and assesses ESG-related regulations, supports business divisions and functions in their implementation, collaborates with external stakeholders on regulatory ESG matters, and integrates technology, data, and innovation into sustainability-related data. Group Sustainability is tasked with establishing bank-wide standards and processes for environmental and social sustainability, including human rights. It controls and oversees the adherence to these standards, including enhanced environmental and social due diligence (ES), and oversees the classification of sustainable finance. ESG Transparency plays a key role in enhancing transparency regarding the Banks sustainability agenda and performance, as well as in fostering dialogue with key stakeholder groups. It develops and implements Deutsche Banks approach to assessing the materiality of sustainability topics and coordinates key ESG rating requests. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities As an Environmental and Social Due Diligence & Sustainable Finance Manager, you will be part of the Group Sustainabilit team within Deutsche Banks Chief Sustainability Office. In this role, you will be responsible for applying and further developing the group-wide frameworks for managing environmental and social (ES) risks in the banks core business, as well as for classifying transactions under Sustainable Finance (SF) criteria. Supporting environmental and social due diligence for new clients and transactions, as well as contributing to the classification of deals under the Sustainable Finance framework. Contributing to the development, implementation, and continuous improvement of related guidelines, processes, training programs, and control mechanisms. Preparing presentations, reports, and analyses on ES and SF topics for internal and external stakeholders. Raising awareness of environmental and social issues and associated risks, and delivering training sessions globally and within your region. You will support the engagement process with NGOs and rating agencies on environmental and social topics in India. Your skills and experience Minimum of 3 years of experience in a financial institution, investment bank, consultancy, or professional services firm, advising on sustainable practices, environmental, social, and governance (ESG) issues, and related regulations. At least 2 years of proven experience specifically in Environmental and Social (ES) and/or Sustainable Finance (SF), ideally with a focus on valuation or transaction analysis involving environmental and social considerations, aligned with internationally recognized standards (e.g., Equator Principles, IFC Performance Standards). Solid knowledge of current ESG regulations and guidelines, including Sustainable Finance frameworks. Minimum educational qualificationBachelors degree in Business Administration, Political Science, Natural Sciences, or a comparable field. Highly self-motivated and detail-oriented, with a strong sense of initiative and urgency, and the ability to manage multiple competing deadlines effectively. Comfortable working in an international role and dynamic, fast-paced environment, with a pragmatic, proactive, and solution-oriented mindset. How well support you
Posted 3 weeks ago
10.0 - 15.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Industry: Payments/ Financial Services business Functional Area: Payments and Financial Services Role: Senior Manager Reporting to :Director Legal Key Skills: Drafting, vetting, and negotiating agreements, Providing legaladvice, Product counselling, Interpreting regulations and providing guidance to internal teams, Risk identification and Management. Experience: Minimum 10+years experience, including experience inPayments/ FinancialServices/ FinTech (required). Education University Degree in law. A Masters Degree in Law is not mandatory, but will be an added advantage. Location: Bangalore PRIMARY RESPONSIBILITIES : Business Reviewing existing products, as well as new products/ features, with the lens of ensuring they are in line with applicable laws and critical industry practices. Providing legal guidance to, and working closely with Compliance, Business and other stakeholders, in this regard. Drafting, reviewing, negotiating, and closing contracts (relating to the payments/ financial services business, banking contracts etc.) with the internal and external stakeholders, with a view to protect the organization against any legal exposure and to minimize liability. Provision of legal advice in framing/ review of policies, and other internal and external documents. Staying updated on the regulatory environment; identify, interpret, and analyse existing and new legislations/ amendments/ notifications that may impact business; and basis its applicability and implications, bring it to the notice of appropriate internal functions as required. Advise and assist all stakeholders including Compliance and Business on both, ongoing legal risks and anticipated/ new legal risks arising by virtue of new laws or regulations. Internal process Adhere to timelines in reviewing and vetting all documentations, including agreements. Follow up with internal stakeholders, including business leads,for time bound closure of agreements;provide advice in course corrections; escalate when required. Monitor the timelines for submission of applications pertaining to licences (new and renewals) to regulatory authorities and ensure timely escalation where required. Learning Maintain a database on applicable laws comprising FAQs, dos anddontsas a ready reference. Keep a track on the latest lawsand notifications (including all notifications issued by the RBI), and proactively advise the management and business about such laws/ amendments and its implication on business, and accordingly suggest changes in process/ procedure. PhonePe Full Time Employee Benefits (Not applicable for Intern or Contract Roles) Insurance Benefits - Medical Insurance, Critical Illness Insurance, Accidental Insurance, Life Insurance Wellness Program - Employee Assistance Program, Onsite Medical Center, Emergency Support System Parental Support - Maternity Benefit, Paternity Benefit Program, Adoption Assistance Program, Day-care Support Program Mobility Benefits - Relocation benefits, Transfer Support Policy, Travel Policy Retirement Benefits - Employee PF Contribution, Flexible PF Contribution, Gratuity, NPS, Leave Encashment Other Benefits - Higher Education Assistance, Car Lease, Salary Advance Policy Working at PhonePe is a rewarding experience! Great people, a work environment that thrives on creativity, the opportunity to take on roles beyond a defined job description are just some of the reasons you should work with us. Read more about PhonePe on our blog. Life at PhonePe PhonePe in the news
Posted 3 weeks ago
7.0 years
12 - 14 Lacs
Hyderabad
Work from Office
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Data Acquisition Specialist Min 2 + yrs of experience in Data Acquisition domain. Expertise in Handling Non-CRF activities, able to work autonomously on the non-CRF data strategy. In-depth understanding of Data Management conventions, data standards, Processes and Drug development Process. Experience with Study convention including non-CRF collection data standards, Processes, Knowledge sharing and best practices on assigned studies. Influence Study Team to adhere non-CRF guidance, processes and negotiate contingency plans to mitigate delays of deliverables. Task: Lead collection of non-CRF data during Study Setup, Conduct and Closeout activities IXRS and Complex Data Models. Effectively communicate non-CRF data collection deliverable, Status of work and Data issues to the assigned study team and SME’s. Collaborate with multiple non-CRF vendors or data providers to setup Data Transfer Agreement to ensure timely and quality delivery.
Posted 3 weeks ago
7.0 - 12.0 years
35 - 50 Lacs
Hyderabad
Work from Office
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 – 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. Behavioural Skills • Integrity driven decision making skills • Collaboration and teaming with ability to work in a matrix environment • Strategic thinking & sound analytical skills • Big picture orientation with attention to detail • Sense of urgency & desire to excel • Intellectual curiosity • Self-awareness and adaptability • Result oriented and performance driven • Excellent interpersonal & communication skills to effectively interact with a broad range of audience. 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/#!/
Posted 3 weeks ago
0 years
0 Lacs
Thane, Maharashtra, India
On-site
POSITION PURPOSE: The position is responsible for the medical and scientific support, including technical advice to the Business Units and Pharmacovigilance/ Medical Information and Clinical Research teams in their assigned therapeutic areas. This is crucial in view of the complex marketing environment in India due to the presence of generic players and self-pay nature of the market. The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with (if applicable) Regional Medical Affairs functions and relevant Global Medical Affairs functions. This position holder is responsible for ensuring that marketing and sales functions have appropriate medical scientific support and training (the latter in co-operation with the Training department). To enable this support, product and development project information is to be kept up to date based on internal publications and communication with regional and global Medical Affairs functions as well as based on review of pertinent scientific publications. In addition to this, the position holder is responsible for the review process of promotional materials in the respective area according to the global SOP and local laws and compliance. The tasks also include monitoring of medical marketing activities of competitors locally and worldwide and close interaction especially with regional medical affairs functions. The position holder will further support regulatory, PV/MI and CR teams in medical scientific questions and prepare and give internal (mainly marketing and sales functions) and possibly external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products. This also includes interaction and relationship-building with Thought Leaders (TLs – Key HCPs). YOUR TASKS AND RESPONSIBILITIES: Medical Marketing Provide timely and appropriate medical review of all promotional material as well as challenging promotional activities of competitors where appropriate. Support development of marketing strategies with respective to competitor innovator and generic brands. Support BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs, if applicable) to support the business Build up good relationships with customers and TLs Build strong relationships with internal customers (marketing and sales) and with regional / global Medical Affairs Provide development project and product training internally to marketing and sales functions and externally to doctors and conduct refresher trainings at appropriate intervals. Support and educate internal customers in compliance with the Country’s Code of Conduct Provide a comprehensive and proactive Medical service that encompasses, as appropriate, including Medical Support, Medical Information and Pharmacovigilance As Medical/Scientific Advisor, is responsible for overall medical inputs to Integrated Brand Plans of assigned therapeutic areas, provision of scientific expertise, review of promotional materials, thought leader management, speaker development and training. Takes responsibility for study development programs of the Business units within portfolio (included local studies OS, NIS, IIR). Identifies initiates and completes agreed study development activities in a timely manner, be IIR responsible of local IIR. Takes responsibility for all study development activities that they are running in accordance with all applicable external and internal regulations and guidelines. Play a role as local medical expert for Global Clinical Development by providing inputs for medical queries related to trials; participate in site feasibility. Respond to all external scientific and medical queries from physicians, regulatory authorities and public alike in an accurate, transparent and convincing manner in order to position Bayer as a credible, trustworthy and professional leader in the industry. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (e.g. Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in the interaction with patients. Develops, maintains and strengthens strategic partnership with relevant TLs, societies and associations. Act as medical contact for TL and external Medical experts. In collaboration with local marketing to develop, conduct Advisory Board meetings, Congress and Symposia. WHO YOU ARE: Graduate/ Post graduate degree (MBBS/MD) in life sciences is preferable. Experience and expertise in relevant TA’s or in industry is preferable. Experience in driving and managing the medical strategy for various brands in the pharmaceutical industry. Clinical research and trial management experience, and be able to interact authoritatively with key stakeholders and investigators. Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events. Independent, self-driven, pro-active, extrovert and dynamic Ability to form relationships quickly and have demonstrable persuasive abilities Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as well as in presentations Strong team player and know how to collaborate and engage many stakeholders across a large organization Innovative and pro-active and has ability of strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment. Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/enfstrategyfstrategy Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext. Please don’t rely upon any unsolicited email from email addresses not ending with domain name “bayer.com” or job advertisements referring you to an email address that does not end with “bayer.com”. For checking the authenticity of such emails or advertisement you may approach us at HROP_INDIA@BAYER.COM I co-create in networks to leverage expertise YOUR APPLICATION Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination. Location: India : Maharashtra : Thane Division: Pharmaceuticals Reference Code: 850077 Contact Us 022-25311234
Posted 3 weeks ago
0 years
0 Lacs
Hyderābād
On-site
Summary Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing. About the Role Major accountabilities: Global and /or regional, cross-functional leadership of assigned pharmacovigilance processes across Novartis Divisions to ensure compliance with worldwide regulations with maximum efficiency -Globally responsible for compliance, quality, efficiency and management of Post Marketing and Clinical Trial adverse event handling -Lead management of activities /interfaces with other Global Line Functions management, Investigator Sites, Novartis affiliates and Novartis Sectors management to ensure timeliness, consistency and quality of safety information and to achieve a common understanding of other departmental needs. Build high performance safety teams with challenging clear objectives in alignment with Global functional objectives to facilitate implementation of strategic initiatives. Accountable for delivery of continuous operations ( quality and compliance) goals. Optimize operational efficiency and clinical trial effectiveness by ensuring speedy follow-up for key safety information -Manage direct reports. Responsible for ensuring recruitment, development of top safety talent and retention of high performing associates to maintain stable pharmacovigilance operations. Ensure regular performance evaluations, development and succession planning -Manage audits and inspections. Takes complete responsibility for timely implementation of necessary corrective and preventive actions (CAPA commitments). Maintain inspection readiness at all times to minimize findings -Distribution of marketing samples (where applicable) Key performance indicators: Adherence to Novartis policy and guidelines -Project and stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections Minimum Requirements: Work Experience: Critical Negotiations. People Challenges. Operations Management and Execution. Collaborating across boundaries. People Leadership. Skills: Clinical Trial. Databases. Employee Training. Pharmacovigilance. Project Management. Reporting. Safety Science. Team Management. Languages : English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Development Business Unit Innovative Medicines Location India Site Hyderabad (Office) Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Posted 3 weeks ago
1.0 - 3.0 years
0 Lacs
Hyderābād
On-site
Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy 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 Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for? •Ability to establish strong client relationship •Ability to handle disputes •Ability to manage multiple stakeholders •Ability to meet deadlines •Ability to work well in a team 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 Bachelor of Pharmacy,Master of Pharmacy
Posted 3 weeks ago
0 years
0 Lacs
Chennai
On-site
Senior 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 Senior Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Reporting Associate at ICON, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will work closely with cross-functional teams to enhance the organization’s pharmacovigilance reporting processes and maintain compliance with regulatory standards. What You Will Be Doing: Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness. Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation. Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations. Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process. Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation. Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities. Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements. Staying informed about changes in regulatory guidelines and industry standards to ensure ongoing compliance and best practices in pharmacovigilance reporting. Your Profile: Bachelor’s degree in life sciences, pharmacy, or a related field. An advanced degree is preferred. Extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines. Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner. Strong analytical skills, with the ability to interpret safety data and identify trends or issues requiring further action. Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams. Proficiency in pharmacovigilance databases and reporting tools, as well as Microsoft Office Suite. Ability to manage multiple projects and priorities in a fast-paced environment while maintaining attention to detail. Commitment to maintaining confidentiality and handling sensitive patient information with discretion. 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. 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 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.
Posted 3 weeks ago
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