Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy Conduct research and stay updated on the latest advancements in oncology treatments Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care Must have an MD/MS/M.Ch degree with extensive experience in medical oncology Experience in clinical trials and cancer research publications is a plus

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy Conduct research and stay updated on the latest advancements in oncology treatments Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care Must have an MD/MS/M.Ch degree with extensive experience in medical oncology Experience in clinical trials and cancer research publications is a plus

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Role Summary MSL embody our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimise medical practice and drive appropriate adoption of BMS medicines. The MSL role is a field-based role. It is anticipated that a MSL will spend a minimum of 60-70% of their time in the field with external customers. The primary role of MSL is to develop and maintain contacts with Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer-to-peer discussions aligned with medical strategies and needs expressed by the stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management and BMS products in a fair and balanced way and includes appropriate Health Economics and Outcomes Research (HEOR) data. Key Responsibilities External Environment and Customer Focus Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSLs will use various channels for interactions (1:1, group presentation; remote, etc). Develop and execute a medical interaction plan with Key accounts (Army, Railways, CGHS etc.) as per the needs of the stakeholders and the overall medical strategy. Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers. Collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures. Contribute to the Country Medical Plan Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs. Execute certain medical plan activities as assigned. Adopt institution/account planning approach and contribute to cross-functional institution/account plans. Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan. Provide Medical Support As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access). Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers. Support Clinical Trial Activities Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document. Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management. Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document. Support HCPs in the ISR submission process as agreed with local medical management. Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events. Contribute towards the Patient advocacy programs Support the implementation of the patient education programs in collaboration with the patient advocacy groups. Support the creation of patient education materials. Report safety information, including adverse events, in accordance with BMS Standard Operating Procedures Qualifications MBBS, MD, BDS, MDS 1-2 years of Field Medical experience in medical affairs is preferred. Candidates with experience in the Oncology and Haematology therapy area will be preferred. Languages Excellent English language skills - spoken and written. Experience And Knowledge Working in a scientific and/or clinical research environment Ability to work independently and act as a team player. Have an innovative mindset and approach. Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients. Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals Ability to quickly and comprehensively learn about new subject areas and environments. Disease area knowledge and an understanding of scientific publications Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts (Health economic and outcome research) is a plus. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Responsibilities BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less

Description Safety & Pharmacovigilance Specialist I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. Enters data into safety database. Codes events, medical history, concomitant medications, and tests. Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Maintains safety tracking for assigned activities. Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required. Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA. Manual recoding of un-recoded product and substance terms arises from ICSRs. Identification and management of duplicate ICSRs. Activities related to SPOR / IDMP. Quality review of ICSRs. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process. Fosters constructive and professional working relationships with all project team members, internal and external. Participates in audits as required/appropriate. Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities. Qualifications What we’re looking for Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job. Safety Database systems and knowledge of medical terminology required. Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance. Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet. Ability to work independently and in a team environment. Excellent communication and interpersonal skills, both written and spoken. Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. Detail oriented with a high degree of accuracy and ability to meet deadlines. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Show more Show less

I am sharing with you the details related to the profile and the company below and kindly acknowledge this email with your updated resume: Company website : https://ultragenicglobal.com/ Company LinkedIn Page : https://www.linkedin.com/company/ultragenic/mycompany/?viewAsMember=true Job Description for Argus Config. : Should have good understanding of the Pharmacovigilance/ Health Care domain. Should have excellent knowledge of Oracle Argus Safety/LSMV or other PV/Safety systems. Should have experience in installing/configuration/validation of Argus Safety and customizations. Should have good knowledge of SQL, PL/SQL. Should have experience in configuring reports in Argus Aggregate and Periodic reports. Should have experience in Regulatory Standards like 21 CFR Part 11, ICH, GxP. Should have experience in Argus Business and system configuration. Should be able to provide technical architecture and design as per the user requirements. Should have experience in performing System Integration and User Acceptance testing as part of upgrade/ implementation projects. Should have good understanding of regulations (EU, FDA, MFDS, NMPS, Mexico, Taiwan and Russia). Thanks & Regards, Tripti Kumari Associate Principal - HR tripti.kumari@ultragenicglobal.com

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Medical Writer to join our Core Labs in Mumbai office. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities •Generate, revise, and maintain clinical documents; •Coordinate quality control of documents and maintain audit trail of reviews and changes; •Provide input on data analysis planning and its impact on clinical document outcome ; and •Performs other duties and responsibilities as assigned. Qualifications Master’s degree in a health or science-related field; Possess strong communication skills (oral and written); Intermediate knowledge of medical terminology and clinical patient management; People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. EO/AA Employer M/F/Disability/Vets

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Position Summary- This is a global role which supports the Patient Safety (PS) Mission and Vision through understanding the impact of daily work on all stakeholders of Safety Management Plans (SAE MP's) and Pharmacovigilance Agreements (PVA's).This role provides oversight of quality and process optimization working with multiple global stakeholders across PS and external functions to ensure business critical support to the management of and reporting associated with SAE MPs and PVAs. Major responsibilities will be the drafting, review, negotiation, execution and maintenance of SAE MPs and PVAs as assigned. Duties/Responsibilities Demonstrate strong teamwork skills to ensure accurate production of SAE MPs and PVAs including the processes, procedures, and best practices are consistent across PS and that regulatory requirements are met in a timely manner and with high quality Periodically review and update SAE MPs and PVAs per internal process Builds and maintains strong relationships with other BMS functional areas to complete and facilitate implementation of SAE MPs and PVAs Identifies ways to improve productivity and quality standards for SAE MP and PVA-related deliverables and actively participates in efforts to remedy non compliance situations Review and evaluate integrity of CRO SAE management processes for inspection readiness. Apply knowledge of specific work practices, Standard Operating Procedures (SOP), and regulations to maintain oversight of SAE MPs and PVAs and ensure successful execution of tasks. Engage and develop working relationships with Preferred CROs and Business Partners to ensure alignment with BMS processes. Maintain a customer service focus with internal and external colleagues. Take personal initiative by proactively identifying innovative ways to accomplish tasks and drive toward process efficiencies. Utilize effective organizational skills to prioritize deliverables to accomplish work in established timeframes. Contribute to continuous quality improvement process through projects and other related departmental initiatives. Develop expertise in associated applications and web systems (e-TMF, Veeva Vault, PVA and SAE MP Management system. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less

Site Name: India - Maharashtra - Worli Mumbai Posted Date: Apr 29 2025 Job Purpose: Provide scientific and technical expertise of the highest standards for local medical information, including interactions with Key External Experts (KEEs) and Key Opinion Leaders (KOLs) Provide medical and scientific input and information for business strategy for the region. Key Responsibilities : Develop and sustain credible networking with appropriate Health Care Practitioners (HCPs) Plan, facilitate and conduct CMEs, symposia, trainings, workshops, scientific meetings, speaker tours, and other product specific campaigns and deliver scientific presentations with consistent messages for key products at these meetings, as required. Support and deliver scientific presentations with consistent “on label” messages at medical education meetings. Understand principles of and support Scientific Engagement (SE) activities as per Medical Plans. Have clarity in understanding on Scientific Engagements and Promotional Code. Become an expert in oncology where GSK have brands and support associated activities related to those brands. Be updated on scientific knowledge on oncology; GSK molecules and its PI to ensure its ‘On Label’ communications on various platforms. Support in feasibility assessment of potential research sites, develop concept notes, proposals, budgets, data collection and monitoring tools for field studies. Provide medical inputs into development and execution of brand strategy. Pharmacovigilance: Support Named Safety contact in strengthening of oncology Pharmacovigilance; ensure self-learning. Knowledge/ Education / Previous Experience Required Educational Background :- Minimum Level of Education - MBBS with post graduate qualification Preferred Level of Education - Post graduate qualification in Pharmacology / Public Health Why is this Level of Education Preferred - To interact with specialized HCPs Job-Related Experience:- Minimum Level Of Job-Related Experience Required Excellent written and oral communication skills in English, local language Experience of presenting scientific topics at different settings A sound understanding of the principles and practice of ICH-GCP and internal SOPs. Well-demonstrated ability to understand scientific methods and experimental design. 1-2 years in the pharmaceutical industry preferably in the oncology therapy area. Hemato -oncology mandatory. Other Job-Related Skills/Background:- General Competencies Presentation skills at Scientific meetings Communication skills, both verbal and written Technical writing skills Keep up to date with new developments Ability to provide and receive constructive feedback Build and maintain relationships with colleagues Share knowledge with other team members Work as part of a team to reach common goals Deliver creative ideas for continuous improvement Develop good relationships with key opinion leaders Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine. 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We are looking for a Business Development Manager to lead growth initiatives in our Pharmacovigilance (PV) services , with a strong emphasis on AI integration . This role requires deep knowledge of PV processes and regulatory compliance, as well as experience in AI-driven innovations and client acquisition in the life sciences sector. Key Responsibilities: Identify and pursue new business opportunities in pharmacovigilance and AI-powered services. Build and maintain relationships with pharmaceutical companies, biotech firms, and regulatory bodies. Promote and support the adoption of AI tools for adverse event reporting, signal detection, and risk management. Collaborate with cross-functional teams (PV, AI, data science, marketing) to develop customized solutions and proposals. Conduct market research and competitor analysis to inform strategy. Achieve sales and revenue targets; track performance against KPIs. Qualifications: Bachelors degree in Life Sciences, Pharmacy, Biotechnology, or related field; advanced degree (MBA, MPH, MSc) preferred. 5+ years’ experience in business development in PV, life sciences, or healthcare. Familiarity with AI applications in PV (e.g., NLP, machine learning, automation). Strong communication, negotiation, and presentation skills. Certification in pharmacovigilance or AI-related fields is a plus. What We Offer: Competitive salary with performance-based incentives. Exposure to innovative PV and AI technologies. Collaborative and inclusive work culture.

Avillion Biogenics Pvt. Ltd. is looking for Clinical Executive to join our dynamic team and embark on a rewarding career journey. Take vital signs and record medical histories of patients, and update electronic medical records as needed. Assist physicians or other medical professionals in clinical procedures such as physical exams, immunizations, and specimen collection. Prepare patients for exams, procedures, and treatment, and provide instructions on post-treatment care. Answer patient inquiries and provide education on medical conditions and treatments. Assist with scheduling patient appointments and follow-up visits, and maintain medical records. Administer medications and treatments as directed by physicians or medical professionals. Communicate with patients, physicians, and other healthcare professionals to ensure the efficient operation of the medical office or clinic. Knowledge of medical terminology and procedures. Strong communication and interpersonal skills.

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships with stakeholders, associations, etc. through appropriate management of expectations and objectives, ensuring consistent and effective communication. Will handle the Invoicing, NFA, payment disbursement activities, etc. Draft representations, communication for various stakeholders. Additional Responsibilities: Supporting corporate communications efforts with different stakeholders. Monitoring key industry events and, ensuring ENGIEs participation at appropriate levels to enhance visibility and influence.

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy. Conduct research and stay updated on the latest advancements in oncology treatments. Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care. Must have an MD/MS/M.Ch degree with extensive experience in medical oncology. Experience in clinical trials and cancer research publications is a plus.

Diagnose and treat cancer patients, providing personalized treatment plans including chemotherapy, radiation, and immunotherapy. Conduct research and stay updated on the latest advancements in oncology treatments. Collaborate with a team of surgeons, radiologists, and pathologists to ensure comprehensive patient care. Must have an MD/MS/M.Ch degree with extensive experience in medical oncology. Experience in clinical trials and cancer research publications is a plus.

Sam Tech Datasys Pvt. Ltd. is looking for Medical Transcription Trainer to join our dynamic team and embark on a rewarding career journey. Identifying training needs: Assessment of employee skills and knowledge gaps to determine the type of training required Designing training programs: Creating customized training programs that meet the specific needs of the organization and its employees Delivering training sessions: Leading classroom-based or online training sessions, using a variety of teaching methods to engage participants and enhance learning Evaluating training effectiveness: Monitoring and evaluating the impact of training programs on employee performance and business outcomes Keeping up to date with industry developments: Staying informed of new trends and developments in the training field to ensure the organization's training programs remain relevant and effective

Dr.Medcare 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.

Avron Hospitals Pvt. Ltd. is looking for Pharmacy Assistant / 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.

Senior 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 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 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

Senior Pharmacovigilance Reporting Associate 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. 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

Avron Hospitals Pvt. Ltd. is looking for Clinical 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.

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 to 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 Job Description: Act as SME for safety business and track industry trends relevant to safety Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry Build partnership with senior leadership across the industry in Safety and PV Represent the company in trade conferences, speaker sessions etc. Identify and build potentially synergistic partnerships to expand client and service footprints Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Must Have - MBBS/ MD with a minimum of 8-10 years of experience in drug safety or a related field; Master/Diploma in Management degree is added advantage - Experience in the pharmaceutical industry, preferably in drug safety, pharmacovigilance, or clinical development - Knowledge of pharmacology, toxicology, and clinical trial methodology - Understanding of FDA and international regulatory requirements related to drug safety and pharmacovigilance - Strong analytical and problem-solving skills - Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams - Demonstrated ability to prioritize tasks and manage multiple projects simultaneously - Proficiency in data analysis tools (e.g., Excel, SAS) and safety databases (e.g., Argus, ARISg) - Good communication skils and relationship building skills - Act as SME for safety business and track industry trends relevant to safety - Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions - Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities - Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry - Build partnership with senior leadership across the industry in Safety and PV - Represent the company in trade conferences, speaker sessions etc. - Identify and build potentially synergistic partnerships to expand client and service footprints - Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Good to have EQUAL OPPORTUNITY

As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute & plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Divisions success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation & development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. LOCATION: India > Chennai : 147 Greams Road t

Job title : Pharmacovigilance Case MR Oversight Specialist Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Main Responsibilities The primary function of the Case Medical Review (MR) Oversight specialist is to perform the medical and regulatory evaluation of all ICSRs. Oversee the Medical Review of ICSRs as per predefined activity and job-role in PV safety database (DB), with special focus on case medical accuracy and documentation. Maintain overall accountability for the timeliness and quality of medical Case Management activities outsourced to service providers. Be the product medical expert from Medical Review Standpoint for all High priority Products and provide training & guidance to MR teams Lead or participate in cross-functional projects or initiatives within global PV collaborates with the Global Safety Officer (GSO) in the review of clinical trial and post-marketing program documentation and on labeling activities. Establish strong collaboration with cross-functional groups within and outside the company (i.e. Business Partners, CRO). Provide or receive training on Customer-specific processes, systems, or products. Perform daily quality review for ICSRs to allow analysis of data entry/ quality. Reconcile SAEs between the Clinical and Safety DBs to meet joint accountabilities and enable locking of Clinical DB. Provide support for the preparation of response to ad hoc HA queries, provide input into responses to inquiries from health care professionals on safety issues. Assist in study configurations of clinicals trials in the safety database Responsible for performing oversight of non-serious line listing as applicable. Creates and maintains relevant SOPs, job aids for medical review activity. Other PV tasks as required Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. Minimum 4 years of pharmaceutical industry experience with a focus on pharmacovigilance Strong Experience in medical review of ICSRs Experience in labelling and causality assessments is must. Experience in overseeing vendors responsible for case processing. Experience with SDEA agreements Experience review in signal activities, RMP, PBRERS, and PADERS etc. Strong experience review of non-serious line listings. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office Strong experience in ICSR quality review and submissions Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities. Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings) Education MD (Pharmacology) degree with 2 years' experience required / or MBBS/Pharm D equivalent Academic qualification is desirable with 4 years’ experience in Global PV/Clinical environments. Languages : Fluent in English (verbal and written) Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers: We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less

Job title : Pharmacovigilance Case Management Oversight Specialist Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. Main Responsibilities The primary function of the PV Case Management Oversight specialist is to review end-to-end ICSR management process and ensure its seamless operation. This role includes evaluation of cases submitted to FDA/EMA/MHRA. Below is the detailed responsibility. This role contributes to safety management activities in cooperation with OPELLA CSE PV, Country PV team, Health Authorities (Has), partner companies and other functions in compliance with global procedures and local regulatory PV requirements. Liaise with CHC Country Safety Head (CSH), CHC GRA and CSE PV case management vendors on an ongoing basis to achieve compliance to the HA PV requirements. Responsible for overseeing Inbound & outbound management of the ICSRs of specified HAs. Review and improve/streamline the oversight case management process for specified HAs. Responsible for overseeing timely submissions of ICSRs/ PV reports to the HA as per regulations. Responsible & accountable for oversight of Tasks and Correspondence within Safety DB to ensure compliance is met regarding follow-up letters, corrections etc. Provide Quality oversight of the follow-up letter package for data entry created by vendors through retrospective Quality Review (i.e. Tasks and Correspondence from previous week to be reviewed in the current week). Documentation of discrepancies in the follow-up letter package Responsible for implementing CAPAs for late cases and audit/inspection findings from respective HAs. Liaison with QPPV Office for case management (CM) related activities. Responsible for Case management related QDs/Job aids management. Manage and Oversee Distributor related activities for Case Management Additional Activities For US Case Management Oversight Specialist This role is responsible to oversee the implementation and management of the overall AE case processing & DB management operation in the US including but not limited to CM for marketed CHC products, safety evaluation, Food and Drugs Administration (FDA) reporting, PTC management of medical device/drug device combination products, PV inspection/ audit and outsourcing vendor management. Support US case processing operations including PTC management with medical device/drug device combination product Responsible for managing USPV Mailbox and reconciliation of inbound reports in USPV Mailbox with the reports entered in Safety DB, and documentation of discrepancies. Processing and documentation of USPV Mailbox source document requests. Other PV tasks as required. Additional Activities For EMA/MHRA Case Management Oversight Specialist Oversee downloading of the cases from Eudravigilance (EV) and creation of these cases in safety DB for Medical Literature Monitoring (MLM) and National Competent Authority (NCA) ICSRs. Oversee EMA and MLM related product list for Opella. Interact with Literature team for MLM related activities Responsible for oversight of E2B submissions for EMA ICSRs. Responsible to maintain and improve EMA device related activities Responsible to oversee case intake and submission for EMA G2 countries with no CSHs. Coordinate with European Union (EU) Countries for oversight of any Local HA related Activities (ex. submissions, etc.) Responsible for configurations of EMA related Clinical Trials in Safety DB. Responsible for ensuring CPD is update for fulling foreign case submission requirements. Any other EMA oversight Activities for PV Ops. To solicit local regulatory obligations from appropriate SMEs and assess impact to the global standardized process. Other PV tasks as required. Experience About you Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. Minimum 5 years of pharmaceutical industry experience with a focus on pharmacovigilance Experience in case processing activities. Experience in overseeing vendors responsible for case processing. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Strong experience of USFDA/EMA/MHRA regulations Strong understanding of reporting rule configuration in the Safety database Good knowledge of MS Office Strong experience with RCA, and implementation of CAPA Experience with PSMF is preferred. Strong experience in ICSR quality review and submissions Strong GVP module VI experience required. Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Technical Skills Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, MHRA, other health authorities, and ICH. Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings). Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Education Bachelor’s Degree in Pharmacy / Life Sciences / or equivalent Academic qualification is desirable with 5 years’ experience in Global PV/Clinical environment. Languages : Fluent in English (verbal and written) Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers: We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers Show more Show less

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The purpose of the Sr. Associate / Lead / Senior Lead, MQO is to support the development and implementation of the strategy for quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas. Primary Responsibilities Implement and Manage Quality Systems Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned. Recommends new quality system documents or changes to existing quality system documents where applicable. Advise on appropriate training for implementation and documentation. Provide consultation on the interpretation and practical application of external requirements, standards, and procedures. Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed. Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary. Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps. Complete self-inspections and drive improvements that are meaningful and actionable Ensure local implementation of the quality systems as necessary. Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned. Provide Quality Oversight for business area(s) Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions. Communicates and escalates to management as appropriate. Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions. Provide updates to quality and business owners. Seek and implement simplification and process improvement. Coordinate quality improvement initiatives. Review metrics and trending to improve processes and compliance, as assigned. Compile compliance metrics and maintain metrics process (for example, periodic report metrics). Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports). Monitor completion of deviations, change controls, CAPA, audit responses. Audits and Inspections Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses). Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions) Ensure completion of audit corrective action plans and timely resolution. Leads and/or supports readiness activities in collaboration with business partners. Partnership With Other Area(s) Functions as the initial point of consultation for business areas on quality related questions. Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place. Shares key learning to drive simplification and replicate best practices Collaborates with other quality groups as appropriate and develops quality network. Establishes good working relationships with assigned business area(s). Actively participates in team, business and quality related meetings. Supports issue resolution including escalation. Utilize a risk-based approach in guiding business areas. Support key projects as assigned. Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable. Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned. Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures. Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality. Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems. Minimum Qualification Requirements Bachelor’s Degree in a science/technology/health care related field or equivalent work experience Demonstrated ability to apply quality systems within a regulated work environment Effective project and time management skills Demonstrated ability to communicate effectively, both written and verbal, and to influence others Demonstrated ability to prioritize and handle multiple concurrent tasks Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies Strong interpersonal skills with demonstrated flexibility in varying environments/geographies Effective organization/self-management skills Other Information/Additional Preferences Experience in a quality control/quality assurance role Experience in Statistics or Data Management Knowledge of quality systems Ability to work independently and as part of a team Demonstrated ability to work in a global environment Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly 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. #WeAreLilly Show more Show less

Summary In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders About The Role Key Responsibilities Support country medical affairs strategy in line with the global strategy, country insights and market conditions, and implementation of Medical Affairs activities within the designated therapy area(s). Coordinate scientific meeting, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring value to the therapy area; develop engagement plan(s) for country customer-facing activities and events, and ensure timely execution of the activities in an efficient and compliant way. Ensure enquiries are responded to in a quality, timely manner, and in accordance with applicable standards; establish response documents for frequently asked questions. Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the therapeutic area. Support country strategy for Non Interventional Studies/Investigator Initiated Trial activities. Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for partner engagement and events are tailored to local needs, and reviewed/approved per local/P3 guidelines. Ensure medical insights are provided to cross-functional groups, including, but not restricted to: Pharmacovigilance, Regulatory Affairs, Market Access, QA, Commercial and Brand team and others. Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities Essential Requirements MBBS; MD Mandatory with min 1+ year industry experience Operations Management and Execution Project Management Collaborating across boundaries Clinical Trial Design, Data & Reporting Medical Science and Disease Area Knowledge Medical Education and Scientific Engagement Non-Interventional Studies (NIS) / Epidemiology Studies Medical Governance and Medical Safety Desirable Requirements: Cardiovascular Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment To Diversity And Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. 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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network 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 Show more Show less