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1.0 - 2.0 years
3 - 4 Lacs
Hyderabad, Pune, Bengaluru
Work from Office
We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible
Posted 1 week ago
0.0 - 1.0 years
2 - 3 Lacs
Hyderabad, Pune, Bengaluru
Work from Office
Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage
Posted 1 week ago
0.0 - 1.0 years
2 - 3 Lacs
Hyderabad, Pune, Chennai
Work from Office
Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.
Posted 1 week ago
0.0 - 1.0 years
2 - 5 Lacs
Hyderabad/Secunderabad, Pune, Bengaluru
Work from Office
Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.
Posted 1 week ago
0.0 - 1.0 years
2 - 5 Lacs
Hyderabad/Secunderabad, Pune, Bengaluru
Work from Office
Should have knowledge in Clinical Data Management Should have good knowledge in edit checks crf design SAE Reconcilation crf annotation Good knowledge in Startup conduct phase and close out phase Required Candidate profile Strong understanding of clinical data management and E2b Guidelines Excellent clinical assessment and Communication Skills
Posted 1 week ago
0.0 - 1.0 years
3 - 4 Lacs
Hyderabad, Pune, Bengaluru
Work from Office
Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying medical or technical information into clear, structured documents and engaging content. Good Knowledge of Medical terminology. Required Candidate profile Preparation of protocol for Clinical trials Preparation writing CSR (Clinical Study Report) BDS and MBBS With medical writing for clinical trials Knowledge are Applicable
Posted 1 week ago
0.0 - 1.0 years
2 - 5 Lacs
Hyderabad/Secunderabad, Pune, Bengaluru
Work from Office
Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply
Posted 1 week ago
6.0 - 10.0 years
0 Lacs
karnataka
On-site
As an experienced professional in the pharmaceutical industry, you will be responsible for ensuring the pharmaceutical, medical, and regulatory accuracy of English product information for European procedures. In this role, you will work with innovative, biosimilar, and generic products, contributing to regulatory compliance and addressing internal and authority-related inquiries. Your day-to-day activities will involve creating and updating compliant English product information for EU procedures, strategic planning for changes affecting multiple product documents, evaluating and approving change requests, and coordinating submissions with EU regulatory units. Additionally, you will collaborate on patent-related issues, contribute to readability studies, and ensure compliance with legal requirements. You will also be involved in monitoring safety updates from EU authority websites, tracking reference product updates and legal changes, assessing the need for updates based on Company Core Safety Information, implementing safety updates in line with SOPs, and participating in Product Safety Group Meetings. Your role will also include scientific work, authority communication, coordination of packaging mockups, addressing authority queries, and assisting with training new team members. To excel in this position, you should have 6 to 7 years of experience in medicinal information and EU labeling in the pharmaceutical industry, ideally in Regulatory Affairs. A completed university degree in natural sciences, such as Pharmacy, Biology, Human Biology, Medicine, or Food Chemistry, preferably with a PhD, is required. Proficiency in spoken and written English, strong MS Office skills, and knowledge of European pharmaceutical law and regulatory affairs are essential for success in this role. If you are looking to be part of a global team dedicated to making good health more affordable and accessible, this opportunity to contribute to the regulatory compliance of life-changing medicines may be the perfect fit for you.,
Posted 1 week ago
1.0 - 3.0 years
0 Lacs
Bengaluru, Karnataka, India
On-site
Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services 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. 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? Drug Safety Associate Drug Safety Associate 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 1 week ago
1.0 - 3.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services 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. 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? Drug saftey associate 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 1 week ago
1.0 - 3.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services 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. 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? Drug saftey associate 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
Posted 1 week ago
7.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
Job title: Sr. Specialist - Quality Services (Product Complaints) Location: Hyderabad About The Job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main Responsibilities Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site. Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Consulting to FAR team in case of any filed alert expected (as applicable). About You Experience: 3 – 7 years of related experience in the pharmaceutical industry. Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering. Languages: Verbal and written fluency in English Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
Posted 1 week ago
20.0 years
0 Lacs
Hyderabad, Telangana, India
On-site
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Document Specialist position is responsible for formatting, reviewing compiling, and processing regulatory documents (both Word and PDF) in support of electronic publishing activities with a focus on quality, accuracy, and efficiency providing publishing support to ProPharma clients. Essential Functions Directly supports electronic submission of regulatory documents / applications including IND, CTA, NDA, BLA, MAA, etc. through formatting, processing, and compilation of Word and PDF documents to the appropriate client specifications. Formats and reviews Word documents in preparation for publishing, in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. Performs document conversion to PDF, and formats and reviews PDF documents to specification (for eCTD compliance), including bookmarks, hyperlinks, keyword linking, document properties, etc., in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines. Compiles regulatory documents / reports, gathering all required documents, within all established timelines. Publishes regulatory documents according to all relevant guidelines and specifications for eCTD submission, performing all relevant pre- and post-publishing quality review checks. Prepares and transfers final documents for publishing, supporting client and internal team during submission preparation, routing documents for review and approval, where applicable. Adheres to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2) / M4, EU MDR / IVDR, Company standard operating procedures, and client standards instructions. Supports multiple publishing activities / projects simultaneously and manages own workload, ensuring completion of all projects within established timelines, immediately escalating any issues. Manages client expectations and interacts and communicates directly with clients to ensure accuracy and maintain timeline integrity. Performs peer / quality review of documents processed by other team members as requested. Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to document publishing. Brings issues and potential concerns to line manager / client oversight manager’s attention in a timely manner. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). May occasionally be required to work outside of normal business hours to support client’s needs. Other duties as assigned. Necessary Skills And Abilities Extensive knowledge and mastery of Microsoft Word (advanced level formatting). Extensive knowledge and experience with Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems (e.g., ISI Toolbox, Core Dossier). Excellent problem-solving skills, including the ability to think outside the box. Ability to work on multiple projects at a time. Exceptional project management and communication skills with a high attention to detail and quality. English language proficiency. Ability to think proactively and take initiative, with a willingness to take on new challenges. Ability to work independently and contact management team proactively when additional support and resources are needed. Ability to work effectively in a collaborative team environment. Ability to work within established working hours. Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements Bachelor’s degree, preferably in life sciences (or related field). Experience Requirements Minimum 3 years of experience in document publishing and / or formatting. Pharmaceutical / biotech industry experience (specifically, INDs / CTAs, NDAs / BLAs / MAAs) preferred. Other professional and/or educational experience may contribute toward these minimum requirements, as determined on a case-by-case basis. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Posted 1 week ago
1.0 - 4.0 years
3 - 7 Lacs
Ahmedabad
Work from Office
: Prepare and maintain the Signal Schedule as per Standard Operating Procedures. Identification, Analysis, and Evaluation of safety signals arising from various data sources to determine signals or risks that could result in changes to labels and / or benefit-risk profile of the product. Evaluate the safety information and prepare product specific ADR (Adverse Drug Reaction) Sheet. Author Drug Safety Report (DSR) for Valid signals as per Standard Operating Procedures. Communicate findings from routine and ad hoc signal detection and assessment activities to concerned stakeholders. Contribute to cross-functional initiatives aimed at improving pharmacovigilance capabilities related to signal detection. Maintain awareness on new or revised regulatory requirements and guidelines relevant to Signal Management. Ensure regulatory compliance (quality, procedures, regulations, timeliness, consistency) for Signal Management process. Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents concerning Signal Management. Impart trainings related to Signal Management activities, as and when required Skills Required: Regulatory Medical Writing | Intermediate Medical Literature Review & Analysis | Intermediate Adverse Event Reporting & Signal Detection | Advanced Regulatory Affairs Collaboration | Intermediate Safety Data Analysis & Visualization | Advanced
Posted 1 week ago
3.0 - 7.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site. Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Consulting to FAR team in case of any filed alert expected (as applicable). About you: Experience: 3 7 years of related experience in the pharmaceutical industry. Knowledge of cGMP s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: bachelors or Masters in Life Sciences/Healthcare, Business Administration, Engineering. Languages: Verbal and written fluency in English Why choose us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, we'll-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and we'llbeing benefits including high-quality healthcare, prevention, and we'llness programs and at least 14 weeks gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowe'red to propose and implement innovative ideas.
Posted 1 week ago
0 years
0 Lacs
Mumbai Metropolitan Region
On-site
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Sr Medical Advisor - Oncology 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. The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with 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 TLs. 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 BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs) 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 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 Senior Medical 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 programmes of the Business units within portfolio (included local studies 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. Support the Local Safety Issue and Crisis Management in collaboration with the Headquarters. Support the local Safety Management Team. 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: Certified Medical Doctor from a recognized Medical University (MBBS and MD in Pharmacology). More than three (3) years’ of experience as Medical Advisor in Oncology or Hematology Have in depth Disease Area expertise and technical knowledge in the assigned therapeutic areas. For the role is desirable: Experience in driving and managing the medical strategy for Specialty therapy area like Oncology or Hematology. Clinical 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, collaborative and customer focused. 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 Highly organized with attention to detail Strong team player and know how to collaborate and engage many stakeholders across a large organization Solid negotiation and decision-making skills Good analytical and numerical abilities Adaptability Innovative Strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment Willing to travel 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. 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 : Mumbai Division: Pharmaceuticals Reference Code: 850670 Contact Us 022-25311234
Posted 1 week ago
4.0 - 5.0 years
1 - 3 Lacs
Surat
Work from Office
We are looking for a skilled Branch Receivable Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 4-5 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, ensuring timely payments and minimizing bad debts. Develop and implement effective strategies to improve cash flow and reduce outstanding amounts. Collaborate with the collections team to identify and resolve issues related to overdue accounts. Analyze financial data to provide insights on customer behavior and trends affecting receivables. Maintain accurate records and reports on receivables, including aging analysis and credit risk assessments. Ensure compliance with regulatory requirements and internal policies related to receivables management. Job Requirements Strong knowledge of accounting principles, financial regulations, and banking practices. Excellent analytical, problem-solving, and communication skills. Ability to work effectively in a fast-paced environment and meet deadlines. Proficiency in MS Office and other relevant software applications. Strong attention to detail and ability to maintain accurate records. Experience working in a similar role within the BFSI industry is preferred.
Posted 1 week ago
4.0 - 6.0 years
5 - 7 Lacs
Bengaluru
Work from Office
2. In depth knowledge of Indian / Global (EU, US and TGA) pharmacovigilance guidelines / regulations 3. Strong knowledge and understanding of medical terminology and clinical development processes Required Candidate profile Educational qualification Graduation/post-graduation in Pharma, science or any life science Function/department Pharmacovigilance only accepted who has worked in pharma company in this function
Posted 1 week ago
1.0 - 3.0 years
1 - 4 Lacs
Bengaluru
Work from Office
Education - PhD, MD, BDS, MDS, with specialization in Medical Genetics, Molecular Biology, Genomics, or related fields. Who are we HaystackAnalytics is a HealthTech company creating clinical genomics products, which enable diagnostic labs and hospitals to offer accurate and personalized diagnostics. Supported by India's most respected science agencies (DST, BIRAC, DBT), we created and launched a portfolio of products to offer genomics in infectious diseases. Our genomics based diagnostic solution for Tuberculosis was recognized as one of top innovations supported by BIRAC in the past 10 years, and was launched by the Prime Minister of India in the BIRAC Showcase event in Delhi, 2022. Key Responsibilities Scientific Engagement & Field Support Build and maintain strong relationships with KOLs and HCPs in the fields of medical genetics, genomics, reproductive medicine, oncology, and other relevant specialties. Work closely with the sales team. Present scientific and clinical data accurately. Serve as the primary scientific contact for inquiries related to genetics-based products and services. Participate in scientific advisory boards, conferences, and symposia as a representative of the medical/scientific team. Medical Affairs & Education Support the development and delivery of scientific training programs for internal teams (sales, marketing, customer support). Conduct educational sessions, CMEs, and academic presentations for external stakeholders. Assist in the creation and review of medical/clinical content, including white papers, presentations, and medical communication materials. Clinical Support & Insights Provide scientific support for clinical trials, real-world evidence projects, and post-marketing studies. Collect and report medical insights from the field to help guide product development and marketing strategy. Support clinicians with test interpretation, report explanation, and phenotype-genotype correlation where needed. Compliance & Documentation Ensure all activities comply with applicable regulatory, ethical, and legal guidelines. Maintain up-to-date knowledge of relevant literature, genetic technologies, and clinical guidelines (e.g., ACMG, ESHG). Qualifications PhD, MD, BDS, MDS, with specialization in Medical Genetics, Molecular Biology, Genomics, or related fields. Key Competencies Strong communication and presentation skills for both technical and non-technical audiences. Strategic thinking with the ability to align field activities to company goals. Ability to work independently and collaboratively in a cross-functional environment. Willingness to travel Pan India
Posted 1 week ago
1.0 - 3.0 years
2 - 6 Lacs
Bengaluru
Work from Office
Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components (documents) of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for sBachelor Degree in Life Sciences Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation
Posted 1 week ago
0.0 - 1.0 years
3 - 7 Lacs
Gurugram
Work from Office
Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 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 Required Skills: Strong coping, emotional resilience, and stress-management skillsExcellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking 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 Good Communication Skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation
Posted 1 week ago
3.0 - 5.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking 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 Commitment to qualityAbility to work well in a teamAgility for quick learningAbility to manage multiple stakeholdersAbility to handle disputes Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom
Posted 1 week ago
0.0 - 1.0 years
3 - 7 Lacs
Bengaluru
Work from Office
Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: BCom Years of Experience: 0 to 1 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking 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 Commitment to qualityAdaptable and flexibleAbility to work well in a teamAgility for quick learningAbility to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification BCom
Posted 1 week ago
3.0 - 5.0 years
4 - 8 Lacs
Bengaluru
Work from Office
Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 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 Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for Commitment to qualityCollaboration and interpersonal skillsAbility to work well in a teamAbility to perform under pressureAbility to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom
Posted 1 week ago
6.0 - 10.0 years
8 - 12 Lacs
Bengaluru
Work from Office
We are looking for a skilled Accounting Specialist to join our team in the Merchandise Payables department. The ideal candidate will have 6-10 years of experience in accounting and finance, with expertise in managing merchandise payables and ensuring timely payments. Roles and Responsibility Manage and process merchandise payables transactions accurately and efficiently. Coordinate with cross-functional teams to resolve payment-related issues and discrepancies. Develop and implement effective accounting procedures to improve financial performance. Analyze financial data to identify trends and areas for improvement in merchandise payables. Ensure compliance with company policies and regulatory requirements. Maintain accurate and up-to-date records of merchandise payables transactions. Job Requirements Bachelor's degree in Accounting or Finance. Minimum 6 years of experience in accounting and finance, preferably in retailing. Strong knowledge of accounting principles and practices. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment and meet deadlines. Strong communication and interpersonal skills. Experience working with J C Penney Services India Pvt Ltd is preferred.
Posted 1 week ago
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