Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait . We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. Job Description Job Summary We are looking for Team Member-Medical information & Customer Support for ensuring efficient processing of quality complaints and adverse events. You will collaborate with various internal stakeholders, including the quality, PV teams, sales, marketing, and legal teams, to address customer concerns and ensure compliance with standard operating procedures (SOPs) and regulatory guidelines. Your responsibilities will include handling customer complaints, providing accurate medical information, coordinating adverse event reporting, and maintaining effective communication with cross-functional teams. Roles & Responsibilities Customer Services Cell (CSC) Ensuring Efficient Quality Complaint and Adverse Event Processing Collection of Complaint samples, original bill copy from customers through marketing team, sending them to QA and collection of filled CIOMS and sending them to PV teams. Ensuring the free flow of complaints with regard to their Logging and Closing through CSC mail/telephone. Follow-up with the Customers, Marketing, Pharmacovigilance and Quality Assurance teams for better processing of complaints. Monthly Reconciliation of AEs with the (GPVC) Pharmacovigilance Team. Answering Product related Queries of the Customers via Customer Services Mail Box on daily basis Medical Information (Info-Jini) services Addressing scientific Power point presentation requests received from HCPs through the sales team and Medico-Marketing Team Responding to the Scientific Query Requests from the external customers sent through the sales team and Medico-Marketing Team Managing clinical queries related to GGI portfolio products by providing scientific evidence based literature to sales or marketing team Administrative work - to ensure proper compilation and extracting of the data in Info-Jini. Preparation of log-sheets, Monthly report sheets, outsourcing, archiving, maintenance of Journals & library/database. Toll-Free services – Effectively handling calls from various external stakeholders on product queries and reporting quality/PV complaints. Maintain logs of the calls and appropriately report to the internal teams through customer services cell. Cross functional interaction for closure of issues Assist in handling customer queries, complaints, and adverse event reporting. Support interactions with both internal and external stakeholders to facilitate resolution. Assist in providing essential information for medical inquiries from doctors, coordinating with various stakeholders to ensure accurate and timely responses. Audits Assist in maintaining documentation to ensure readiness for internal and external audits. Support the implementation and adherence to corrective and preventive action plans (CAPA) as directed. Qualifications Educational qualification: M. Pharm, Pharm D. or Phd will be value addition. Minimum work experience: 3-4 years of experience in customer service-oriented roles, Regulatory Affairs/PV/Medical Information/ Medical Writing. Managerial experience/Training customer services/call centers will be added advantage. Skills & attributes: Technical Skills • Proven experience in customer support or client service representation. Sound scientific knowledge • Customer-oriented mindset with the ability to adapt and respond effectively to internal and external stakeholders. • Proficiency in Microsoft Word, Excel, and PowerPoint. Behavioural skills • Strong written and verbal communication skills. Excellent interpersonal & communication skills to effectively interact with a broad range of audience Ability to interact and handle challenging internal and external stakeholders Driving quality standards by taking everyone along Integrity driven decision making skills Strong multitasking skills with keen attention to detail. Effective time management and organizational skills to manage multiple tasks efficiently. Self-awareness and adaptability Result oriented and performance driven Strong sense of empathy in addressing customer calls Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/ Show more Show less

Primary Responsibilities QA test engineer experienced with functional and system testing preferably worked on life sciences products on validated test environment. 8+ years overall experience and at least 4 yrs. experience in validation testing in regulatory environment. Review requirements, specifications and create manual test cases for OQ testing. Perform manual test executions for OQ testing in validated test environment. Capture test results and test evidence as per the expected result. Able to log the defects/deviations, analyze the issues and track them until they resolve. Working knowledge with functional, regression, system and DB testing. Proficient in SQL and able to create and execute medium to complex SQL queries. Proficient in SDLC agile or V-model methods. Ability to follow the release timelines and deliver the assigned task within the release. Document test results and review with the project team and clients as needed. Knowledge with risk-based functional and regression testing by analyzing the requirements and changes. Familiar with FDA 21 CFR part 11 and EU compliance guidelines and knowledge of GXP systems. Proactive with the changes in the applications and update the test suite as needed. Knowledge of ETL, data migration testing. Secondary Responsibilities Knowledge of automation regression test scripting and execution. Knowledge in web services testing tools like postman etc., Worked on Highly configured products, applications, and reports. Knowledge of SOPs, templates and WIS documents. Qualifications Education: BE/BTech or any 4 yrs. degree in any discipline. Experience: Life science software products testing with data analysis skills. Experience with pharmacovigilance data management is an added advantage. Additional Skills Strong motivational skills and abilities, promoting a team-based approach. Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills and Goal-oriented. Ability to maintain professional and positive attitude. Show more Show less

We are looking for an MSL- Oncology for a Global Pharmaceutical MNC Profile: Medical Science Liaison- Oncology Location: Delhi/ Kolkata/ Chennai (3 openings) Qualification: MD Pharmacology fresher or with minimum 6 months of experience MDS/ PhD with minimum 1yr of Oncology experience as MSL/RMA Job Purpose: The Medical Science Liaison (MSL) will establish the company’s medical affairs presence with external stakeholders through scientific exchange and research support in oncology. The focus will be on licensed and non-licensed products for hard-to-treat cancers, including metastatic pancreatic cancer, cholangiocarcinoma, digestive cancers (such as stomach cancer, pancreatic cancer, and cholangiocarcinoma), glioma, brain tumors, hematologic cancers (acute myeloid leukemia, acute lymphoblastic leukemia, and lymphoma), and pediatric cancers. This role is field-based, covering the India region. The MSL will communicate balanced therapeutic area-related, product-related, and clinical information to external stakeholders (e.g., physicians, academic institutions, hospital formulary committees), respond to unsolicited requests for medical information, facilitate research discussions, and bring key insights from the medical and scientific community to internal stakeholders. The role also involves ensuring compliance with all company procedures, confidentiality standards, and contributing to business success with a focus on patient safety. Principal Accountabilities: 1. Exchange of Medical and Scientific Information: Responsible for communicating fair and balanced therapeutic area-related, product-related, and clinical information to external stakeholders. Execute the scientific engagement plan in alignment with the Therapy Medical Plan. Proactively develop long-term peer-to-peer relationships with opinion leaders and relevant stakeholders. Respond to unsolicited requests for medical information, including off-label data, related to marketed products and pipeline products. Provide clinical and medical presentations to external stakeholders as needed. Disseminate updates from scientific meetings and report information of strategic interest to cross-functional teams. 2. Supporting Clinical Research: Support ongoing and future Medical Affairs Company-Sponsored Studies, providing country-level review of proposed research site lists, attending site visits if necessary, and providing feedback to the line manager. Support unsolicited requests for investigator-initiated trials (IITs) proposals by offering appropriate investigator support as per company SOPs. Assist in the development and support of national disease registries and Real-World Evidence (RWE) projects as necessary. 3. Contributing to the Organization through Medical Expertise & Market Insights: Maintain up-to-date knowledge of scientific/medical developments in the relevant therapeutic area through literature searches, clinical papers, conferences, and other relevant events. Capture and share in-field insights to develop territorial Field Medical Plans and support medical and scientific strategies. Provide medical and scientific expertise to commercial partners within regulatory guidelines. Act as a field-based scientific and clinical reference for internal stakeholders (e.g., sales, market access) through training and ad-hoc support. 4. Cross-Functional Collaboration: Support the development of medical/scientific materials, ensuring content is reviewed and approved according to company policies. Contribute to the development and execution of the regional medical affairs strategy and action plan in collaboration with field departments such as Sales, Clinical Research, and Market Access. Keep medical representatives and their managers informed about the latest scientific developments. Support the market access strategy at a regional level, including hospital listings, in coordination with the market access manager. 5. Compliance with External Regulations and Company Policies: Maintain a high level of scientific, clinical, and environmental knowledge through courses, self-learning, and attendance at relevant meetings. Stay informed about regulations related to medical information services in the pharmaceutical industry. Ensure all activities comply with internal and external codes of conduct, prioritizing patient safety by following pharmacovigilance processes. Support the company’s reputation in the field by adhering to industry regulations. 6. Patient-In Activities: Support patient awareness initiatives, both physical and digital. Contribute to the Patient-In strategy, understanding the patient journey in coordination with therapeutic area experts, and set up Patient Support Programs (PSPs) to improve patient outcomes as per local regulations. General Administration: Complete all required administration within the specified timelines. Submit monthly reports and expenses by the second working day of each month. Ensure timely completion and submission of all required documentation to the Head Office as appropriate. Profile Requirements A] Minimum Requirements: Education: MBBS/MD Minimum 1-2 years of working experience in oncology. B] Indispensable Qualities: Strong ability to learn new subjects and environments comprehensively. Excellent written and spoken communication and presentation skills, with the ability to build and maintain collaborative relationships with opinion leaders, physicians, and other healthcare decision-makers. Substantial business acumen and autonomy in managing priorities and activities. Strong commitment to compliance with relevant rules and procedures, as well as scientific integrity and quality. Ability to manage cross-functional projects effectively. Leadership skills, emotional intelligence, active listening, and strength of conviction. Negotiation and problem-solving abilities. Proficiency in English is essential. Ability to innovate and execute strategies effectively. Relevant candidates can share their CV at pooja.j@domniclewis.com 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 In line with overall product strategy, the Medical Lead is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organize 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 2+ 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: Ophthalmology &/or immunology 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

Work Schedule Second Shift (Afternoons) Environmental Conditions Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: Performs and may oversee day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Optimally collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. Key responsibilities: Works independently to perform day-to-day PV activities. May participate in on[1]call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites. Operates in a lead capacity. Provides assistance in the development of program and departmental procedural documents. May prepare for and attend audits. Mentors less expert staff. Reviews regulatory/pharmacovigilance publications and information sources t keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states. Reviews cases entered for quality, consistency and accuracy, including review of peer reports. Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Keys to Success Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Knowledge, Skills and Abilities: Thorough understanding of pathophysiology and the disease process Solid understanding of relevant therapeutic areas as the need arises for processing AEs Excellent critical thinking and problem solving skills with ability to evaluate and escalate appropriately Proficient at sophisticated clinical study administration including budget activities and forecasting Excellent oral and written communication skills including paraphrasing skills Good command of English and ability to translate information into local language where required Computer literate with the ability to work within multiple databases Proficient in Microsoft Office products (including Outlook, Word, and Excel) Thorough understanding of the global regulatory requirements and the importance of and compliance with procedural documents and regulations Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision Strong attention to detail Ability to maintain a positive and professional demeanor in exciting circumstances Ability to work effectively within a team to attain a shared goal Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Show more Show less

About ICBio Clinical Research Pvt. Ltd.: Headquartered in Bengaluru, India, ICBio is a full-service Contract Research Organization (CRO) with over 16 years of experience in conducting Bioavailability/Bioequivalence (BA/BE) studies and Phase I–IV clinical trials. We have successfully completed over 1,000 BA/BE studies and approximately 500 clinical trials. Our services are approved by several global regulatory bodies, including ANVISA Brazil, DCGI, CDSCO, MHRA, UAE MOH, GCC, MOH Kazakhstan, and Zambia . Our NABL-accredited central laboratory is fully integrated with LIMS, ensuring high-quality data and compliance. Our Services Include: Bioavailability/Bioequivalence Studies Phase I–IV Clinical Trials Bioanalytical Services Regulatory Affairs and Dossier Preparation Pharmacovigilance Clinical Data Management and Biostatistics Medical Writing job responsibilities Managing the projects/ studies for timely start and completion of the projects in conformance to GLP guidelines. Allocate personnel for conducting bio analytical study and maintain list of persons to whom trial related activities are delegated. Ensure that the study personnel are qualifies by appropriate education, training and experience to accept the responsibility for the delegated study related activities. Method Development and Method Validation, executing methods for analysis of drugs using Solid Phase extraction, Liquid-Liquid extraction and Precipitation techniques for BA/BE studies are as per applicable regulatory requirements. Ensure compliance to GLP and safety in Lab, Assessment and training of staff on GLP and SOPs and applicable regulatory guidelines. Implementation of Standard Operating Procedure for the analytical method developed and general procedures. Ensure that all relevant SOP’s are available in work place. Ensure routine maintenance and calibrations of all the equipment’s used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc. Ensure computerized systems used in the studies has been validated as per the regulatory requirement. Review and provide inputs for the documents like protocol, study reports, method validation reports, method SOP’s etc. and finalize the same in co-ordination with other departments. Review of the electronic generated data, raw data and logbooks to ensure validity and accuracy. Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure. Approve the individual sample repeats, ISR and investigation of batch failures. In case of any deviation from the protocol, assess and document the impact on the quality and integrity of the study and take appropriate corrective action when necessary. Ensure regular instruments backup and study related documents are archived properly. Show more Show less

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Job Purpose and Key Responsibilities: Provide support for Central Safety Department (CSD) literature screening activities for both ICSR and signal detection purposes in accordance with their procedures and regulatory requirements Support SERM product specialists by identifying articles of interest for relevant safety information from screened publications for all of GSK s product portfolio Perform PV literature surveillance activities according to appropriate regulations and agreed processes Ensure timely production of key deliverables including but not limited to: Screening and review of literature search results (articles/abstracts/citations) for purposes of ICSR identification Triaging literature search results for potential articles of interest with relevant safety information concerning both GSK marketed and GSK products in development, for signal detection/periodic reporting purposes using defined algorithms and criteria Accountability: Breadth/Scope of Accountability - Number of Direct Reports Number of Indirect Reports 0 0 Complexity (this is best illustrated for this role by the behaviors needed to perform effectively): Decision Making: Developing confidence in making decisions Makes decisions based on facts, common sense with the support of mentors or manager Understands and can articulate decision making process Teamwork: Works effectively with others to achieve business goals and objectives Bridges personal, business and cultural differences to work effectively in team settings Communication: Has effective communications with internal audiences, tailoring information appropriately Responds with confidence to more complex questions using sound judgment Translates complex science into simple messages that resonate Competencies: Minimum level of job-related experience required: 0 to 2 years of relevant industry experience Pharmaceutical industry experience (e g drug safety (desired), regulatory, clinical development, medical affairs) Working knowledge of key pharmacovigilance regulations and methodologies Good English language skills - written and verbal particularly in scientific/medical terminology Ability to evaluate data and draw conclusions with appropriate guidance from senior team members or manager Good attention to detail Good interpersonal, presentation and communication skills Service-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environment Computer proficiency, IT skills, the expertise and ability to work with web-based applications Good level of flexibility and ability to prioritize work Education: Minimum level of education: Bachelor s Degree - Life sciences (Biology, chemistry, pharmacy, medicine or other relevant scientific discipline) Preferred level of education: Pharmacy, Medical or pharmacology degrees

Alcon Laboratories (India) Pvt. Ltd is looking for Associate I Safety Data Analyst to join our dynamic team and embark on a rewarding career journey. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

Jubilant Organosys is looking for Executive - Pharmacovigilance to join our dynamic team and embark on a rewarding career journey. Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

We are a start-up company offering B2B online marketplace platform connecting medical consumables & devices distributors and manufacturers with healthcare providers such as hospitals, clinics etc. Kogland is a subsidiary of Fingent Corporation and located inside Carnival Info park, Kochi. Skill Set Requirement: Should hold a B. Pharm / D Pharm degree. Should have experience in dispensing drugs for at least 5 years in an offline store. Thorough understanding of dosage administration and measurement, Integrity and compassion. Should have permanent address in Tamil Nadu(Chennai Preferred) as per address proof and currently based out of Kerala( or ready to move to Cochin), Roles and Responsibilities: Review and execute physician s prescriptions checking their appropriateness and legality Listen carefully to customers to interpret their needs and issues and offer information and advice Keep records of patient history and of all activities regarding heavy medication Support Drug Inspector with required documents and sample during inspection Comply with all applicable legal rules, regulations and procedures

Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines. Qualification M. Pharm, M.Sc PhD Additional Information Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.

Overview of Role: Join Alvotech as a Pharmacovigilance Manager and become a key player in our mission to deliver safe and effective treatments to patients worldwide. In this dynamic role, you will lead and manage global pharmacovigilance activities, ensuring compliance with international safety standards and regulations. You will work cross-functionally with various departments, including Clinical Development, Patient Safety, Medical Affairs, and Regulatory Affairs, to support all safety-related activities. Your expertise will be crucial in developing and maintaining our Global PV system, covering both post-marketing pharmacovigilance and clinical safety activities. As a Pharmacovigilance Manager, you will collaborate with internal teams and external partners to ensure the highest standards of safety and quality. This position offers an exciting opportunity to make a significant impact on patient safety and contribute to the success of Alvotech's innovative biosimilar product portfolio. Scope & Responsibilities: Leadership in Pharmacovigilance: Oversee and engage in all PV activities within the Pharmacovigilance department. Global PV System Management: Develop and manage Alvotech's Global PV system, encompassing both post-marketing and clinical safety activities. Cross-Functional Collaboration: Work closely with Clinical Development, Patient Safety, Medical Affairs, and other departments to support safety-related activities. Stakeholder Engagement: Collaborate with internal teams (e.g., Regulatory Affairs, Pharmaceutical Sciences) and external partners (e.g., CROs, service providers) to ensure PV compliance and performance. Safety Management: Manage post-marketing PV activities for assigned products and clinical safety activities for assigned clinical study programs. Comprehensive PV Activities: Oversee global pharmacovigilance tasks including ICSR/SAE processing, literature monitoring, signal management, periodic reporting, risk management, and regulatory submissions. Quality and Compliance: Ensure the PV system is fully compliant with global PV and clinical safety legislation and manage PV audits and inspections. Training and Development: Deliver training on pharmacovigilance processes and standards to staff and external parties. Job Requirements: Education: Master's Degree in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences). Experience: Minimum of 5 years in the pharmaceutical industry with demonstrable PV knowledge. Experience with biosimilars is a strong advantage. Technical Skills: Proficiency in safety databases, Microsoft Office tools, and technical software (Adobe, SharePoint, DocuSign, Veeva suite). Regulatory Knowledge: Detailed understanding of PV processes, directives, regulations, and international guidelines (21CFR, GCP-R3, GVP, ICH, CIOMS etc.). Communication Skills: Fluent in verbal and written English, with excellent communication and team collaboration skills. Independence and Accountability: Ability to work independently, manage time effectively, and prioritize tasks. Positive Work Environment: Maintain a positive, result-oriented work environment and foster a team spirit. Cultural Adaptability: Ability to work in a multicultural environment and willingness to travel internationally as required. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change people's lives. The chance to be part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. A clear and developed organizational structure. Training and global opportunities to advance. A good work-life balance. Home internet and home office equipment. Why Alvotech At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment. True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines. Show more Show less

Data Search & Analysis on the drug discovery and development Creating technology reports Kindly provide minimum two references with resume Required Candidate profile Keen interest in drug discovery, API Good Knowledge of organic chemistry Good Communication Skills

Skill required: Pharmacovigilance Services - Medical Affairs Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 2 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 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. 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 worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for Agility for quick learningAbility to work well in a teamAdaptable and flexible Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification MBBS

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 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 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. 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 worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug Safety ScientistDrug Safety Scientist Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Title Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Cardiologist - Medical Director 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 Participate in oversight of assignments, training, and management of central reader s of cardiac imaging and EKG Collaborat e with Core Lab management on technical aspects of cardi ac study assessments Participat e in sponsor site visits and audits related to cardiac assessments as requested Participati e in training and subsequently demonstrating competency in the operation of independent central review of EKG and cardiac imaging for clinical trials Review protocols, Image Review Charters and associated clinical and technical study documents as required Complete source documents accurately and promptly, according to the specific protocol requirements and Medpace’s SOPs Blinded independent central review of EKG and cardiac imaging according to study endpoints as specified in clinical trial protocol, charter and according to GCP and standard Medpace SOPs Participate in IntraReader and InterReader variability assessments Participate in the development, review and evaluation of SOPs and study specific procedures. Other duties as assigned Qualifications Must have an M.D. and current medical licensure Board Certification preferred. Experience with EKG and most cardiac imaging modalities and expertise interpreting EKG, Holter-EKG and one or more cardiac imaging modality and therapeutic application Experience with various EKG and cardiac image analysis and viewing software (including PACS) Experience working with computer software including Word, Excel, Access and Project preferred Board Eligibility in Cardiology or equivalent training demonstrating competency 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

Role: Opella Global Safety & Medical QD & Training manager 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. Our Team Opella Global Quality is a team of highly motivated people to build the state-of the-art quality with an E2E approach across Opella business and ensure best quality and compliance for our patient safety. Within Global Quality, the Global Science Quality Team is the gatekeeper of quality for all regulated activities in Science (Development & Regulatory, Pharmacovigilance, Medical/Clinical and Innovation projects). We lead and manage the implementation of the Quality management systems within Science organisation to ensure activities and data are managed in compliance with the Global Quality standards and applicable regulatory requirements. Main Responsibilities Of The Mission The purpose of the Global Safety & Medical QD & Training Manager Quality Manager is to manage the operational implementation of the Global QDs & Global Trainings systems within Pharmacovigilance, Medical, RWE & clinical organisation to ensure compliance to Global Quality standards and applicable regulatory requirements (GVP, GMP and GCP). Implement the QD strategy in PV, Clinical medical and RWE, according to the strategy defined by the QD & Training Lead, in collaboration with the respective Quality leaders. Work closely with / support SMEs to ensure timely authoring and approval of all QDs in a right first time approach With a continuous improvement mindset, review QDs and ensure Good Quality document practices are implemented. Coordinate QD process flow Perform Gap assessment and maintain Quality documentation Map and maintain QD packages using Connect master data as appropriate Manage CMS accesses Collaborate with Global QS&E team to secure timely completion of QD processes Build and maintain transversal QD related job aids applicable to Science Quality, with the input of DC Quality Managers and other roles involved in QD management in Science Maintain Science QD writing rules Build and maintain the dictionary of acronyms and definitions used in Science QDs Own the operating guideline related to QD management in Science Implement the Training strategy in PV, Clinical medical and RWE, according to the strategy defined by the QD & Training Lead, in collaboration with the respective Quality leaders Manage LMS accesses Maintain the Training Matrix Update and assigned local & global training curricula to global/local internal & external people Support managers in preparing on-boarding plans Escalate quality issue as appropriate to function quality leaders and direct manager Support Audit & inspection in PV, Clinical, Medical and RWE Ensure QD & training are fully compliant during inspection & audit preparedness Provide QD and training related documents and information during inspection & audit as per inspection lead instructions As the QD and Training Quality Business Partner for the Global Safety & Medical teams: Be the gatekeeper of the Global QD architecture Provide Quality input and guidance to QD authors Share regular QD & training overview to the Safety and Medical leaders Report QD & training KPI Secure CV & job descriptions storage As a member of the Science Quality Operations Team Optimize and standardize detailed operational quality processes for QD & training Closely interact with QD & training BPOs & BSO Back up to direct manager Report QD & training KPI About You Experience: 5-10 years’ experience in QD & Training management Soft skills: outcome obsessed, change agent, decision maker, business partner, assertiveness, networking capability, collaborative & team worker, digital appetite Technical skills: QD & training management in regulated environment Education: Graduate in Chemistry, Biochemistry, Pharmacy, Engineering (related fields) Languages: English is compulsory (working language) - other languages welcomed 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 Description Medical Reviewing PV Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Skills Required RoleLead Medical reviewer Industry TypeIT/ Computers - Software Functional AreaPharmaceutical Required EducationMBBS Employment TypeFull Time, Permanent Key Skills PHARMACOVIGILANCE ICSR Other Information Job CodeGO/JC/21470/2025 Recruiter NameSangeetha Show more Show less

Job Description Medical Reviewing PV Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Skills Required RoleLead Medical reviewer Industry TypeIT/ Computers - Software Functional AreaPharmaceutical Required EducationMBBS Employment TypeFull Time, Permanent Key Skills PHARMACOVIGILANCE ICSR Other Information Job CodeGO/JC/21470/2025 Recruiter NameSangeetha Show more Show less

Role: Opella Global Science QD & Training Head 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. Our Team Opella Global Quality is a team of highly motivated people to build the state-of the-art quality with an E2E approach across Opella business and ensure best quality and compliance for our patient safety. Within Global Quality, the Global Science Quality Team is the gatekeeper of quality for all regulated activities in Science (Development & Regulatory, Pharmacovigilance, Medical/Clinical and Innovation projects). We lead and manage the implementation of the Quality management systems within Science organisation to ensure activities and data are managed in compliance with the Global Quality standards and applicable regulatory requirements. Main Responsibilities Of The Mission The Global Science QD & Training Head Is accountable for the definition, structure and implementation of effective QD & training management systems for GxP regulated activities across Science functions, in compliance with the Global Systems. Impulse the continuous improvement mindset and set the new ways of working to build and maintain a robust and autonomous quality system. Lead the Global Science QD & Training team Define and structure QD & Training Systems across Science in compliance with the Global Systems Work closely with the Global Quality Systems & Excellence team and translate global quality systems into Global Science QD & Training management strategies and principles Ensure adherence of Science functions to GxP requirements Lead and coordinate QD& training systems related to business transformation (CHAMPS, eCTMS, OptiQual…) Continuously improve QD & training management across Science, working closely with other leaders& heads in Global Science Quality Lead the definition of simple and harmonized Learner roles across Science for GxP activities Own the definition of simple working guides to develop a robust, simple and harmonized QD system across Science, including QD Package concept Propose CONNECT improvement opportunities to accelerate and simplify QD & training management in Science Is accountable for and supervise the operational implementation on time and in full of the QD & Training management Quality Systems in Science, except Development centers Ensure consistency of Quality Document architecture and training matrices across Science Ensure compliance to Global Quality Standards and SOPs Review and communicate Quality and Compliance performance through KPIs reporting and perform trend analysis Escalate quality risk & concerns to direct manager in appropriate timelines Provide hands on support as needed Until Regulatory TSA exit, work closely with the Global 2RM Quality lead who is in charge of Global Regulatory QD & Document management operations. Oversee QD & Training management in Development Collaborate with the Global Development Quality Head to align strategies and ensure implementation of Science QD & training management principles Provide QD & Training input and guidance to Development Quality team to ensure alignment of strategies Perform internal checks of the QD systems and Training management systems in development Lead the team of Global Science QD & Training managers Ensure appropriate staffing and risk-based prioritization toward successful implementation of the quality systems Impulse teamwork dynamic Identify synergies and leverage efforts and learning across the Science Quality scopes Engage the team in the Challenger Mindset Culture Promote quality within and outside the quality teams in CHC Manage/contribute to all individual/transversal P&C processes for the team Provide hands on support as needed Impulse the continuous improvement mindset and set the new ways of working to build FMCH company Set and deliver the Quality Roadmaps and ambitious Quality Objectives in alignment with Global business needs Ensure smooth and efficient collaboration with business stakeholders within Science Select and manage external vendors/contractors as needed Manage QD & training service providers Partner with Science leaders and key stakeholders Build robust partnership and collaborate with business leaders, EUQPPV, as well as with the SME network , the BPOs and BSOs Represent quality in key governance bodies/committees or projects or in front of business for QD and/or training related topics Support audit & inspection as the Global QD & training expert for Science Communicate / educate Science SMEs and teams to enhance knowledge of the processes and enhance the robustness of the systems Collect business needs & expectations to ensure client satisfaction Report quality risk, and escalate issues and concerns Contribute to fostering the Quality mindset within Science As a member of the Science Quality Leadership Team & Global Quality Work closely with all Science Quality heads to ensure consistency and alignment across Science Lead Science Quality transversal initiatives Standardize and continuously improve operational processes across Science Escalate and report Science QD & training KPIs Collaborate with other Quality Leaders / heads Closely interact with BPOs Back up to direct manager About You Experience: 10-15 years’ experience in Quality, including QD & Training management - team management – transversal leader Soft skills: managerial competencies, outcome obsessed, change agent, decision maker, business partner, assertiveness, change agent, networking capability, autonomy, digital appetite Technical skills: quality systems in GxP regulated environment Education: Graduate in Quality, Chemistry, Biochemistry, Pharmacy, Engineering (related fields) Languages: English is compulsory (working language) - other languages welcomed 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 : Global Medical expert Hiring Manager: Head Scientific Communications/ Team lead Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About The Job Our Team: Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors Essential Job duties and responsibilities: 1) Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. 2) Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. 3) Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). 4) Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. 5) Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. 6) Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams. People: 1) Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement, 2) Interact effectively with stakeholders in medical and pharmacovigilance departments 3) Constantly assist the medical regulatory writing team in developing knowledge and sharing expertise Performance: 1) Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality Process: 1) Provide medical strategic insights & evaluation related to Sanofi’s portfolio. 2) Contribute to the management of the marketing authorization dossiers of the current related portfolio. 3) Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. 4) Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis 5) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region 6) Work with selected vendors when required within the region to deliver the required deliverables as per the defined process 7) Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables 2) Liaise with the Medical department to ensure relevant & customized are delivered per expectation About You Experience: ≥5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areas- cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills) Education: Medical degree MBBS; MD Languages: Excellent knowledge of the English language (spoken and written) Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Show more Show less

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. Essential Functions With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents). Supervises, trains, and mentors less experienced medical writers, as necessary. Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates. Strives to complete medical writing deliverables on time and within budget. With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines. Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables. Coordinates QC reviews of documents and maintains audit trails of changes as applicable. Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency. If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output). Performs peer review of documents written by other medical writers, as required. Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings). Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership. Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team. Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team. Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.). Other duties as assigned. Necessary Skills And Abilities Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information. Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines. Advanced understanding of regulatory submission requirements and processes. Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures. Exceptional project management skills and strong communication skills with a high attention to detail and quality. English language proficiency and familiarity with American Medical Association (AMA) style. Strong experience in relationship building and strategic collaboration on key business accounts. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables. Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements Bachelor’s degree or higher, preferably in medical or scientific discipline. Experience Requirements Minimum of 6 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company. Other professional and/or educational experience may contribute toward this minimum requirement, 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.*** Show more Show less

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 Medical Information Specialist (MIS) position is part of the ProPharma Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints. Essential Functions Include:Medical Information service delivery Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via telephone, website/e-mail, letter, fax, and scientific meetings on behalf of ProPharma’ s pharmaceutical clients. Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma internal policies and practices. Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner per government regulations, ProPharma Standard Operating Procedures (SOPs) and client Working Practices (WPs). Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs. Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data. Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. Quality Assurance Maintains quality in all areas of the job, including performing quality checks on Adverse Events, Product Quality Complaints, correspondence, and enquiries logged into the Inquiry Handling Systems General Provides after-hours coverage on a rotated basis subject to business requirements. Adheres to company and country-specific privacy policies, ensuring any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations described in ProPharma SOPs and the Confidentiality Statement within the Contract of Employment. Complies with the Company’s health and safety policies. Other activities as assigned as delegated by the Manager. Qualified Candidates Must Have Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree Excellent verbal and written communication skills, including proofreading, professional telephone etiquette and empathetic customer service skills. Ability to write in a fluent and grammatically correct manner in the target language for the role English language proficiency. Japan-based roles only: TOEIC 800= Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards. Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability. Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills. Proactive with demonstrative ability to independently identify problems and suggest effective solutions. Ability to learn, take instruction and apply to daily operations/tasks. Receptive to constructive feedback and able to take responsibility for work allocated. Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects. Effectively work independently and as part of a team. Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database. 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.*** Show more Show less

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