40 Who Jobs

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! 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 Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. 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.

Role & responsibilities 1. Shall responsible to review implementation & maintain of the Quality Management system with the regulations. 2. Determining, negotiating, and agreeing on in-house quality procedures, standards and specifications 3. Checking & Maintaining of Master Documents related to the QMS system. 4. Shall responsible to review filled Batch Production control record & analysis report for batch release. 5. Responsible for coordinate validation activity and validation protocols. 6. Responsible for control and approve deviations whenever raised in the concerned department and record the deviations. 7. Review and approval of the standard operating procedures for other concerned departments. 8. Responsible to plan and carry out internal audits & MRM. 9. Responsible for Coordinate with QC/Production for handling and investigation of Market complaints. 10. Responsible for conducting on-going training programs for new recruits and retraining for existing employees of concern department on the topic of SOP, GTP, GLP cGMP, WHO, ISO, etc. whenever required or as per schedule & Responsible for verifying the effectiveness of training programs system. 11. To check and approve artworks in coordination. 12. Verification and approval of the change control whenever the change in the document, facility, process, and equipment. 13. Verification and approval of documents concern to the production process, analysis including quality system. 14. Responsible for verifying the effectiveness of corrective action and preventive action systems. 15. Responsible to review & maintain system represent in QA department SOPs like OOS, OOT, (document record, storage & retention), Document control, APQR, Calibration, Trend data, etc. 16. Should have better co-ordination with QA, Production, QC, Engineering & Maintenance, for implementation of cGMP and also the electrical department. 17. Responsible for complying with all regulatory queries during any inspection and audit. 18. Responsible for application to FDA, FSSAI, Kosher, Halal, ISO, and others for any approval like Technical person, License/Renewal License, and additional Product, GMP. 19. Also responsible to work on time and to ensure TAT (Turn Around Time) given by Directors, any other job assigned by Superior. 20. Ensuring the manufacturing processes comply with standards at both the national and international levels. Job Type: Full-time

Regulatory Affairs Job Opportunity! Desired Experience : 3- 15 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Manager/ Manager/ Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited) Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc. Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc. Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO. Application for Post Approval Change(s), Variations and Comparability packages Author, review and submission of responses to India, EM, WHO and Regulated markets.. Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc.. Handling the Health Agency audits for India, EM, Regulated and WHO inspections Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External). Review of Artworks (Labels and Package Insert) and Pack Profiles. Any other regulatory support required by the organization per submission need. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for "Regulatory Affairs"

KRA's: Quality check of all raw materials, in-process and finished goods on a FIFO basis QMS Implementation Audit Documentation Internal/ external as well as 3rd party/ regulatory audit compliances Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a medical device/ pharmaceutical manufacturing co. Should be ready to travel or relocate to Taloja Navi Mumbai

QMS Implementation Audit facilitation: will represent the company during regulatory/ 3rd party audits: MHRA, USFDA, MCC, WHO, etc. Products: temperature-controlled packaging & temperature monitoring systems used for storage & transit of medicines Required Candidate profile Any science graduates 10-15 years' experience in quality, ideally in pharma/ medical devices/ equipment manufacturing industry International Audit Experience mandatory Should be open for global travel

KRA's: Ensure SOPs are followed & quality standards are met Quality check of raw materials, in-process & finished goods on a FIFO basis QMS Implementation Audit Documentation Audit facilitation - Internal/ external & 3rd party/ regulatory audits Required Candidate profile 5+ years of experience in Quality [quality inspection, auditing, testing, reporting] in a pharma/ medical device mfg. co Ready to relocate to Medchal, Hyderabad Accommodation & food will be provided Perks and benefits Accommodation and Food provided

Well known Denmark based pharma co Hiring QA Pharmacist Excellent communication skills 5 days working Pl share updated CV to careers5.righthire@gmail.com

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Applications are invited for the Project Associate-I for the MoES funded project under Deep Ocean Mission scheme in the School of Computer Science and Engineering (SCOPE), at Vellore Institute of Technology (VIT), (MoES/PAMC/DOM/58/2023 (E-14510) Title of the Project : Design and Development of Machine Learning Models and Expert System for Automated Characterization of Underwater Species: Indian Scenario Qualification : BE/B.Tech(CSE/IT/ECE/EEE) Describe if any Candidates who have knowledge in programming, app development, image processing, full stack development, machine learning, deep learning and computer related field will be given preference Stipend : Rs. 31,000/- per month + HRA (as per norms) for applicants with CSIR –UGC NET including lectureship (Assistant Professorship) or GATE Rs. 25000/- per month + HRA (as per norms) for applicants who do not fall under (i) above Sponsoring Agency : Ministry of Earth sciences, Government of India, New Delhi . Duration : 24 Months Principal Investigator : Dr. Swathi J N, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Co-Principal Investigator : Dr. Boominathan P, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Dr. Shashank Mouli Satapathy, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Send your resume along with relevant documents pertaining to the details of qualifications, scientific accomplishments, experience (if any) and latest passport size photo etc. on or before ( 5/6/2025) through online http://careers.vit.ac.in No TA and DA will be paid for appearing the interview. Shortlisted candidates will be called for an interview at a later date which will be intimated by email. The selected candidate will be expected to join at the earliest.

Applications are invited for the Senior Project Associate for the MoES funded project under Deep Ocean Mission scheme in the School of Computer Science and Engineering (SCOPE), at Vellore Institute of Technology (VIT), (MoES/PAMC/DOM/58/2023 (E-14510) Title of the Project : Design and Development of Machine Learning Models and Expert System for Automated Characterization of Underwater Species: Indian Scenario Qualification : BE/B.Tech(CSE/IT/ECE/EEE) with Four years’ experience in Research and Development in Industry and Academic Institutions or Science and Technology Organizations and Scientific activities and Services OR Doctoral Degree in Engineering/Technology/MS from a recognized University/Equivalent Describe if any Candidates who have knowledge in programming, app development, image processing, full stack development, machine learning, deep learning and computer related field will be given preference Stipend : Rs. 42,000/- per month (as per eligibility) + HRA (as per norms) Sponsoring Agency : Ministry of Earth sciences, Government of India, New Delhi . Duration : 24 Months Principal Investigator : Dr. Swathi J N, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Co-Principal Investigator : Dr. Boominathan P, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Dr. Shashank Mouli Satapathy, Professor School of Computer Science and Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Send your resume along with relevant documents pertaining to the details of qualifications, scientific accomplishments, experience (if any) and latest passport size photo etc. on or before ( 5/6/2025) through online http://careers.vit.ac.in No TA and DA will be paid for appearing the interview. Shortlisted candidates will be called for an interview at a later date which will be intimated by email. The selected candidate will be expected to join at the earliest.

Guide the upgrade and development of plant infrastructure and systems to meet the requirements of: WHO-GMP, Russia, Australia/New Zealand, and African regulatory authorities, Ultimately UKMHRA and USFDA. Provide expert support on: WHO-GMP and GLP.

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Job Title: FDA & International Pharma Compliance Consultant (Excipients, API & Ingredients & Formulations) Location: Kutch, Gujarat (Remote advisory with periodic on-site presence) Experience: 2025 years in pharmaceutical manufacturing and regulatory compliance Salary: Competitive Education: Bachelors or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry or related discipline Kindly get in touch for career advancement opportunities with us at rupsha.saha@antal.com Roles & Responsibilities Guide the upgrade and development of plant infrastructure and systems to achieve compliance with: WHO-GMP Regulatory requirements of Russia, Australia/New Zealand, African authorities Ultimate readiness for UK MHRA and US FDA audits Provide expert support on: WHO-GMP and GLP compliance for excipients, APIs, and formulation ingredients Equipment qualification (DQ/IQ/OQ/PQ) and cleanroom classification Process and cleaning validation Quality Management Systems (QMS), documentation (SOPs, BMRs, BPRs) and change control protocols Advise on regulatory documentation strategy for DMF and CTD/ACTD filings, including supplier qualification Assist in product selection and formulation pipeline development, identifying high-potential excipients and formulations for domestic and export markets Train and mentor QA, QC, production, and R&D teams on global pharmaceutical standards and best practices Desired Profile 20–25 years’ experience in excipients, API or formulations manufacturing, with a top-tier pharmaceutical company Proven track record of preparing and leading facilities through US FDA, MHRA or TGA audits Deep working knowledge of: ICH Q7/Q8/Q9/Q10 WHO GMP and EU GMP Annexes Indian D&C Act & Schedule M Hands-on experience supporting DMF submissions and familiarity with USP, EP, BP and IP Prior consulting or leadership roles serving regulated export markets Strong grasp of product lifecycle management, export documentation and quality risk management for emerging markets Tech-savvy, with exposure to digital QMS or e-BMR systems (desirable) Awareness of sustainability and EHS standards for global audit readiness Excellent cross-functional collaboration skills spanning production, QA/QC, R&D and supply-chain teams About Antal Antal International is a 30-year-old global executive search and placement firm with a network of over 800 people across 35+ countries, originally based out of the UK.

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support the preparation, review and submission of applications/ response to RCGM vide IBSC f. Support in handling of SUGAM, IBKP, NSWS & ONDLS/ ODLS sites 2. Assisting in Responding Queries to various regulatory authorities. 3. Preparation of dossiers / submission packages for NRA submissions. 4. Preparation of dossiers for registration in ROW countries. 5. Maintenance of Documentation Data base available with RA. 6. Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution and Marketing. 7. Routine Interaction with QA-documentation for updating Master Files. 8. Review of Pack Profiles. 9. Review of Artworks (Labels and Package Insert). 10. Preparation / compilation of technical documents related to tenders / queries. 11. Arranging Samples required for registration. 12. Any other support required by the other members of RA. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for Department Name

Role & Responsibilities Assist in API/intermediate manufacturing as per SOPs. Monitor production processes and ensure GMP & quality compliance. Maintain batch records, logbooks, and related documentation. Handle raw materials, samples, and finished goods safely. Operate equipment such as reactors, centrifuges, dryers, and filters under supervision. Collaborate with QA, QC, and Engineering teams. Maintain workplace hygiene and follow EHS guidelines Preferred Candidate Profile B.Sc. / M.Sc. in Chemistry or related discipline. 04 years of experience in API or intermediate manufacturing (Freshers can apply). Willing to work in rotational shifts. Good knowledge of GMP, safety protocols, and documentation practices. Strong attention to detail, willingness to learn, and teamwork attitude.

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

Qualification - BSC- Nursing, Pbsc Nursing Infection Prevention Policies: Develop, implement and update infection prevention policies and procedures in compliance with relevant guidelines and regulations. Education and Training: Provide education and training to hospital staff, including nurses, physicians and support staff, regarding infection control principles, practices and prevention strategies. Surveillance: Monitor and analyze infection rates within the hospital, conducting surveillance of healthcare-associated infections to identify trends and areas of concern. Isolation Protocols: Establish and enforce isolation protocols for patients with contagious diseases, ensuring proper precautions are taken to prevent the spread of infections. Outbreak Management: Respond to infectious disease outbreaks within the hospital, implementing control measures and coordinating with relevant authorities when necessary. H and Hygiene and Personal Protective Equipment (PPE): Promote proper h and hygiene and the correct use of PPE among hospital staff to reduce the risk of transmission. Cleaning and Disinfection: Ensure that environmental cleaning and disinfection practices meet high standards of cleanliness and hygiene. Device-Associated Infections: Monitor and prevent device-associated infections, such as those related to catheters or ventilators, by implementing best practices. Antibiotic Stewardship: Participate in antibiotic stewardship programs to promote responsible antibiotic use and reduce the development of antibiotic-resistant infections. Data Collection and Reporting: Collect and report infection data to relevant agencies and organizations, maintaining accurate records of infection prevention activities. Compliance and Auditing: Conduct regular audits and assessments to ensure compliance with infection control protocols and recommend improvements when necessary. Quality Improvement: Participate in quality improvement activities to enhance infection control processes and patient safety. Required Skill Sets: 1. Knowledge of infection control principles and guidelines, including those from the CDC and WHO. 2. Strong analytical and problem-solving skills. 3. Excellent communication and teaching skills.

We are currently seeking a Medical Coding Specialist I to join our diverse and dynamic team. As a Medical Coding Specialist I at ICON, you will play a vital role in ensuring the accurate coding of medical data within clinical trials. You will work closely with clinical teams to classify and code medical information, helping to maintain the integrity of clinical trial data and ensuring compliance with regulatory standards. What You Will Be Doing: Accurately coding medical terms, diagnoses, and procedures using standard medical coding systems such as MedDRA and WHO Drug. Ensuring the consistency and accuracy of medical coding across multiple clinical trials. Collaborating with cross-functional teams to resolve coding discrepancies and provide coding-related guidance. Maintaining up-to-date knowledge of medical coding standards and regulatory requirements. Contributing to the development of coding conventions and processes to enhance the quality of clinical data. Your Profile: Bachelors degree in life sciences, healthcare, or a related field. Should have 2-6 years' experience or knowledge in medical coding systems such as MedDRA and WHO Drug. Understanding of clinical trial processes and the role of medical coding in clinical research. Strong attention to detail with excellent organizational and problem-solving skills. Effective communication and teamwork abilities, with a focus on collaboration in a fast-paced environment.

Job Description: Manager / Senior Manager - Quality Control To lead quality control activities in our API /Bulk Drug manufacturing facility in Humnabad. The role involves ensuring that all products meet GMP, WHO, FDA, and other regulatory standards, conducting quality testing, and managing a team of QC professionals. Key Responsibilities: - Oversee quality control processes for raw materials, in-process, and finished products. - Ensure compliance with GMP, WHO, USFDA, and local regulatory requirements. - Conduct laboratory testing, validation, and stability studies. - Handle internal and external audits, inspections, and regulatory documentation. - Investigate quality deviations, implement CAPA (Corrective and Preventive Actions). - Train and supervise QC staff to maintain high-quality standards. - Stay updated with latest pharmaceutical quality trends and compliance norms. Requirements: - B.Pharm/M.Pharm, M.Sc. (Chemistry), or related qualification. - Minimum Experience 18 20 years in QC (API & Bulk Drugs). - Strong knowledge of analytical techniques (HPLC, GC, UV, etc.). - Hands-on experience with GMP, ICH guidelines, and regulatory audits (USFDA, MHRA, etc.). - Excellent leadership, problem-solving, and documentation skills

Job Summary: The Microbiologist will be responsible for ensuring microbiological quality assurance and compliance in pharmaceutical manufacturing processes. The role includes conducting microbiological testing, validation, and ensuring compliance with WHO-cGMP and other global regulatory standards. Location: Ahmedabad (Kalol)- Local candidates preferred Key Responsibilities: Perform microbiological testing of raw materials, finished products, and water. Conduct sterility, bioburden, and endotoxin testing. Oversee environmental monitoring of cleanrooms. Validate microbiological methods and equipment. Prepare and review microbiological reports and documentation. Implement and maintain microbiological controls in line with regulatory standards (USFDA/EU/PIC/S). Investigate microbiological deviations and provide corrective actions. Qualifications & Skills: Bachelors/Masters in Microbiology or related field. 4-6 years of experience in pharmaceutical microbiology. Strong knowledge of WHO-cGMP standards and regulatory guidelines. Excellent analytical and problem-solving skills.

Expertise in ROW market, understanding nuances in regulatory demands across regions in-depth knowledge of FDA Guidelines to ensure compliance in documentation and submissions. Proficiency in handling technical documents to facilitate accurate and timely submissions Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance Strong analytical skills to assess regulatory data and provide critical insights for decision-making Experience in dossier preparation, organizing comprehensive documents for regulatory authorities Attention to detail to meticulously handle documentation and regulatory records Excellent communication skills to liaise with regulatory agencies and internal departments Preparation of registration dossiers as pe regulatory guidelines Preparation of renewal application as per renewal guidelines Facilitate query response raised by regulatory authority and customers Preparation and submission of Safety, Quality & administrative variations as per variation guidelines

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 rich in diversity 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 Collaborate with clinical stakeholders to understand their reporting and analytics needs aligned with study protocols May Translate requirements into comprehensive reporting development specifications, in collaboration with Report end users Support for utilizing existing standard reports whenever possible and to suggest solutions as needed for any new additional requirements Develop reports and analytics visualizations according to specified requirements, ensuring a "first time right" approach Test developed reports, document results, and provide peer review support as needed Adhere to documentation and process compliance, notifying management of any noncompliance Knowledge of regulatory requirements such as ICH, FDA 21 CFR part 11 and GxP Work cohesively with team members, embracing feedback and suggestions Keeping up to date with new reporting tools, techniques, and industry trends to enhance skills and knowledge Plan for your day, make a to-do list and prioritize your tasks based on clinical study needs and consult Line managers for support Embrace feedback and suggestions, continuously working to enhance knowledge and professionalism in the work environment Participate in departmental/organizational activities/initiatives at the site level to build contacts across the organization, fostering collaboration for the benefit of patients Flexible to work with global stakeholders across different time zones while ensuring business continuity as needed 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 an inclusive culture, promoting diversity 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 a diverse 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

Job purpose The Manager/ Sr. Manager of Pharmacovigilance will navigate the complex landscape of clinical safety, on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and state of the art pharmacovigilance post approval. This role reports directly to the Chief Medical Officer at Ocugen. Duties and responsibilities As the Manager/ Sr. Manager of Pharmacovigilance, Clinical Quality, Safety and Pharmacovigilance, you will be tasked with applying sound judgment for the analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation. The role will require the identification and implementation of all clinical standard-operating procedures in order to ensure GCP compliance. The role serves as the senior clinical safety representative in the cross-functional development teams. You will be responsible for setting Ocugens clinical safety strategy for these global projects. The role identifies potential challenges, risks and roadblocks associated with the global safety domain and works as a leader in developing solutions to address these. The role ensures that the medical and process standards delivered at Ocugen are in alignment with following safety objectives expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients, and the general public. Responsibilities include overseeing the safety signal detection and medical signal evaluation process and analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion. Providing a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unblinding clinical data to protect ongoing study participants and complete timely communications to Health Authorities Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards. Participate actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of quality of processes, methods, and communication. Review and contribute to safety relevant SOP and improvement of safety relevant SOPs. Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety. Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function. Set safety strategy based on strong product knowledge and biologicals safety experience that allows for successful IND (Investigational New Drug)/NDA (New Drug Application) filings and initiation of first in human studies. Oversees all processes that lead to the production of safety sections and content of relevant clinical trial documents including protocols, investigator brochures, informed consent forms, clinical study reports. Oversees development of core safety information for new products Provides major contributions to current and potential safety issues, being proactive in addressing safety issues and setting up any additional systems to mitigate risk in Ocugen’s studies. Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment including many interface departments and functions. Complies with legal requirements and company standards of the PV (Pharmacovigilance) tasks and responsibilities: Preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization or from occupational exposure Promoting the safe and effective use of medicinal products through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public Contributing to the protection of patients and public health The role identifies tools necessary to facilitate safety surveillance and clinical safety assessment and to implement necessary risk management initiatives. Provides input into clinical development, due diligence, regulatory and issue management activities from a clinical safety perspective and represents the position of GCSP in internal governance committees and in discussions with Health Authorities Qualifications Eight(8) to Thirteen (13) years pharmaceutical/biotechnology industry experience, of which at least six (6) should be in a safety role, with broad overview of all aspects of a PV system and specific experience in signal detection and risk management. Experience and success in addressing and managing complex safety issues in the pre-approval and post-approval environment including interfacing with external regulatory bodies (written and verbal interactions. e.g. External Audits, Ad Coms, CHMP Oral Explanations, etc.) Knowledge of scientific data relevant to own products and across therapeutic area, including the competitive environment and the disease state Strong understanding of data capture, data management and statistical methods for the preparation and analysis of safety data in clinical trials Detail oriented, exceptional documentation practices, technical writing, and verbal communication skills. Ability to convey complex concepts through clear and concise messages. Excellent problem-solving skills, contingency planning, and risk-mitigation strategies Ability to navigate and be successful in a fast-paced, highly matrixed work environment. Working conditions This position operates in an office setting and may include 20% of travel from time to time. Physical requirements This is a largely sedentary role.

Job Description Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 1-12 years above in production, preferably in the Bio-Pharmaceutical industry, specifically in vaccine manufacturing Educational Qualification: MSc Microbiology/Biotechnology/B. Pharm/B.Tech with more than 8 years of experience in vaccine biologicals and injectables Job Title: Senior Manager / Manager / Executive- Production Job Summary: The Senior Manager /Executive - Production will oversee daily vaccine manufacturing operations, ensure compliance with regulatory guidelines, manage production staff, and drive continuous improvement to enhance operational efficiency and product quality within the pharmaceutical industry. Key Responsibilities: Production Planning and Coordination: Plan, coordinate, and optimize end-to-end vaccine production activities to meet quality standards, timelines, and cost targets while ensuring resource availability. Oversee Manufacturing Operations: Supervise day-to-day manufacturing operations, including formulation, filling, packaging, and storage processes, ensuring efficient workflow and compliance with production protocols. Compliance: Ensure adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory guidelines (FDA, EMA, WHO). Issue Resolution: Troubleshoot and resolve production-related issues to minimize downtime and ensure batch integrity. Team Management: Lead and manage production staff, providing training on safety, quality, and operational protocols specific to vaccine manufacturing. Performance Monitoring: Track key production metrics, implement strategies to improve batch yields, and reduce material wastage. Safety Enforcement: Enforce workplace safety protocols to prevent accidents, contamination, and ensure bio-safety compliance. Risk Management: Identify risks in production processes, such as contamination risks or equipment failures, and develop contingency plans. Material Handling: Ensure safe handling, storage, and disposal of biological materials, vaccines, and hazardous chemicals following industry best practices. Process Improvement: Drive continuous improvement initiatives to enhance production efficiency and product quality. Equipment Management: Oversee the maintenance, calibration, and validation of production equipment to ensure optimal performance. Documentation and Reporting: Ensure accurate documentation of production activities and prepare reports for regulatory compliance and internal audits. Skills and Competencies: Strong leadership and team management abilities in vaccine manufacturing environments In-depth knowledge of GMP, regulatory compliance, and vaccine production protocols Proficient in production planning, batch processing, and process optimization Excellent problem-solving and troubleshooting skills within pharmaceutical production settings Strong communication and interpersonal skills for effective team coordination Risk assessment and mitigation capabilities specific to biological production Commitment to bio-safety, product quality, and continuous improvement About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company dedicated to delivering quality healthcare solutions, with a strong focus on vaccine manufacturing and biological products. Our commitment to innovation, compliance, and operational excellence drives our success. For more information, please visit our website: www.gsbpl.com How to Apply: Interested candidates can apply at: hr@gsbpl.com Contact us at: 8778926365 Apply Now to join our team and contribute to impactful pharmaceutical and vaccine innovations!