1172 Pharmacovigilance Jobs - Page 7

No Relocation Assistance Offered Job Number #167436 - Mumbai, Maharashtra, India Who We Are Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name! Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all. What are we looking for: We are looking for smart, dynamic candidates to join us as trainees who will work in our India Global technology center (GTC) based in Mumbai. It will be a learning & growth opportunity for them to learn about many aspects of Product Lifecycle Management. We are the guardians of Colgate’s Proprietary data in the form of its raw materials and recipes. Data governance of master data of Colgate raw materials and recipes is our primary responsibility. All activity related to assigning correct master data to raw materials and recipes post proper review, assigning access after due diligence of each user’s background and supporting allied functions of the group like PDM data Cleansing and System testing would be a part of the regular activities. Along with this administrative role, every Scientist in India GTech is expected to be an integral part of EHS & Quality standards that ensures Safety & Quality of our products and working environment. This team works on strong partnerships with cross categories within India GTech & other GTechs & plants. The tenure for a trainee is proposed to 2 years from the date of joining. What you’ll need Post graduate in Pure sciences (Chemistry ,Biology)/ Pharmacy/ Technology (Cosmetics) with strong fundamental knowledge in basic chemistry and fair to good exposure to SAP database management / system administration activities and concepts Working knowledge of Microsoft Office or Google Suite proficiency (i.e, Sheets, Slides, Docs) Strong aptitude for computer systems What you will do: 1.Data governance of first level review of CP Raw materials and Recipes within a turnaround time of 72 hours 2. Provide Security Access roles to PDP/DMS /PPM/LIMS system with due diligence 3. Route Human Use Protocols (HUP) through SAP-DMS to the correct reviewers; support the process in Veeva as Admin. Route Adverse Event (AE) for all HUP studies to Pharmacovigilance team who will then perform an evaluation 4. Provide technical support and procedural guidance to 2000+ English-speaking PDM end-users via phone calls, emails and instant messages 5. Support Team in PDM Cleansing / Ancillary activities like Obsoleting recipes and Searches What you will learn: Core expertise on principles that govern data regarding our raw materials and recipes Elements of due diligence while providing access to SAP system users Functional Linkages - you will get an overview of how different departments are integrated into overall R&D eg: Analytical, R&I, Microbiology and implementation & support teams. Operational Excellence - Build on technical expertise, expanding it in complementary directions. Use technical expertise and creativity to proactively identify potential problems and address them using appropriate resources in discussion with team leads. You will also learn to integrate yourself into a high-performing team focused on balancing both execution and innovation. You will be coached for success on technical and soft skills. We will evaluate your progress periodically and ensure scheduled training sessions for your continued success during your traineeship at Colgate. Quality and Safety principles: At Colgate we strive for excellence in everything we do, Quality and safety is not far away. These principles are not only important for our trusted brands but also to our workplaces. You will be exposed to specific training on Q & S, to assure your trust while working in a safe environment where quality is paramount. Compensation and Benefits Salary Range $ - $ USD Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles. Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies. Our Commitment to Inclusion Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business. Equal Opportunity Employer Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law. Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation. For additional Colgate terms and conditions, please click here. #LI-[[filter12]]

Job ID R-227428 Date posted 06/10/2025 Job Title: Senior Scientist - In Vitro Secondary Pharmacology Career Level: D Introduction to role: Are you ready to make a significant impact in the world of drug discovery and development? Join AstraZeneca's Clinical Pharmacology & Safety Sciences (CPSS) department, where innovation meets collaboration. Our Safety Innovation team is at the forefront of advancing a diverse pipeline across therapeutic areas, delivering safety science from early discovery through clinical development. We are seeking a talented in vitro pharmacologist to join our Secondary Pharmacology team, contributing to the clinical advancement of new medicines. Accountabilities: In this pivotal role, you'll leverage your expertise in pharmacology, toxicology, and biology to collaborate with drug safety specialists and project safety pharmacologists. Your insights will shape drug design during the early phases of discovery, ensuring the selection of safer molecules and developing strategies to mitigate safety risks. You'll generate in vitro pharmacological profiling data at contract research organizations (CROs), identify off-target risks, and interpret pharmacological interactions. Your work will translate in vitro activity into pre-clinical and clinical adverse events, providing crucial guidance for project decisions. Essential Skills/Experience: PhD or Masters or equivalent experience in a relevant scientific field with 4+ years of industrial experience. A strong background in pharmacology (e.g., pharmacology, biology, biochemistry, toxicology, physiology) with a proven track record in driving innovative science, preferably in the pharmaceutical or biotechnology industry. Technical experience in in vitro pharmacological or biochemical assay development and screening (e.g., kinase profiling technologies, radioligand binding, enzyme activity, and functional cell-based systems) applied to various biological target classes. Excellent problem-solving and organisational skills, delivery focus, and outstanding communication skills. A true collaborator with highly effective networking skills and experience collaborating across scientific disciplines, cultures, and expertise. Desirable Skills/Experience: Experience with off-target profiling data and strategies in the pharmaceutical industry. Practical understanding of kinase profiling technologies. Experience working with CRO’s, commissioning requests and driving delivery processes. Experience with being entrepreneurial taking the initiative in projects. Demonstrated leadership in scientific projects or teams. Experience in regulatory interactions or safety assessments. Knowledge of emerging trends in drug safety and pharmacovigilance. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we are driven by curiosity and courage, exploring what science can achieve. Our commitment to making a difference is unwavering as we fuse data and technology with scientific innovation to tackle some of the world's most complex diseases. We celebrate successes and learn from failures, creating an inclusive environment where diverse knowledge is leveraged for swift impact on disease. With opportunities for lifelong learning and career growth, AstraZeneca is where you can push boundaries and deliver life-changing medicines. Ready to make a difference? Apply now and be part of a team that transforms patient lives through groundbreaking science! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Senior Scientist - In Vitro Secondary Pharmacology Posted date Jun. 10, 2025 Contract type Full time Job ID R-227428 APPLY NOW Why choose AstraZeneca India? Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare. The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports. Who do we look for? Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day. Success Profile Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for. 0% Tech innovators Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives. 0% Ownership takers If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it. 0% Challenge seekers Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks. 0% Proactive collaborators Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best. Responsibilities Job ID R-227428 Date posted 06/10/2025 Job Title: Senior Scientist - In Vitro Secondary Pharmacology Career Level: D Introduction to role: Are you ready to make a significant impact in the world of drug discovery and development? Join AstraZeneca's Clinical Pharmacology & Safety Sciences (CPSS) department, where innovation meets collaboration. Our Safety Innovation team is at the forefront of advancing a diverse pipeline across therapeutic areas, delivering safety science from early discovery through clinical development. We are seeking a talented in vitro pharmacologist to join our Secondary Pharmacology team, contributing to the clinical advancement of new medicines. Accountabilities: In this pivotal role, you'll leverage your expertise in pharmacology, toxicology, and biology to collaborate with drug safety specialists and project safety pharmacologists. Your insights will shape drug design during the early phases of discovery, ensuring the selection of safer molecules and developing strategies to mitigate safety risks. You'll generate in vitro pharmacological profiling data at contract research organizations (CROs), identify off-target risks, and interpret pharmacological interactions. Your work will translate in vitro activity into pre-clinical and clinical adverse events, providing crucial guidance for project decisions. Essential Skills/Experience: PhD or Masters or equivalent experience in a relevant scientific field with 4+ years of industrial experience. A strong background in pharmacology (e.g., pharmacology, biology, biochemistry, toxicology, physiology) with a proven track record in driving innovative science, preferably in the pharmaceutical or biotechnology industry. Technical experience in in vitro pharmacological or biochemical assay development and screening (e.g., kinase profiling technologies, radioligand binding, enzyme activity, and functional cell-based systems) applied to various biological target classes. Excellent problem-solving and organisational skills, delivery focus, and outstanding communication skills. A true collaborator with highly effective networking skills and experience collaborating across scientific disciplines, cultures, and expertise. Desirable Skills/Experience: Experience with off-target profiling data and strategies in the pharmaceutical industry. Practical understanding of kinase profiling technologies. Experience working with CRO’s, commissioning requests and driving delivery processes. Experience with being entrepreneurial taking the initiative in projects. Demonstrated leadership in scientific projects or teams. Experience in regulatory interactions or safety assessments. Knowledge of emerging trends in drug safety and pharmacovigilance. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we are driven by curiosity and courage, exploring what science can achieve. Our commitment to making a difference is unwavering as we fuse data and technology with scientific innovation to tackle some of the world's most complex diseases. We celebrate successes and learn from failures, creating an inclusive environment where diverse knowledge is leveraged for swift impact on disease. With opportunities for lifelong learning and career growth, AstraZeneca is where you can push boundaries and deliver life-changing medicines. Ready to make a difference? Apply now and be part of a team that transforms patient lives through groundbreaking science! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia What we offer We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you. Lifelong learning Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still. Autonomy and reward Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package. Health and wellbeing An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority. Inclusion and diversity Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? 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. 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. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. 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. Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts BSc,Bachelor of Pharmacy Show more Show less

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? 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. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. 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. Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts BSc,Bachelor of Pharmacy Show more Show less

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? 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. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. 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. Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts BSc,Bachelor of Pharmacy Show more Show less

JOB DESCRIPTION Designation: Clinical Research Coordinator Job Organisation: INPHOG Research Foundation Reporting Manager: Operationally to the Primary Delegate of the INPHOG Member Institution and Administratively to INPHOG Director/HR Manager Years of Experience: >1 year Industry: Research Network Qualification: Bachelors degree in a life science, Clinical Research/ Clinical Data Management or related field required. Master’s degree preferred. Employment Status (Permanent /part time/ contractual): Contractual Period of Contract: 1 year (to be renewed every year) Job Location: Delhi/Lucknow Monthly Salary/CTC: 22000 - 28,000/month (guided my local salary structure) JOB SUMMARY / ROLE: The Clinical Research Coordinator will plan, direct, or coordinate INPHOG clinical research projects, and will evaluate and analyse clinical data. JOB RESPONSIBILITIES: To facilitate and coordinate the all daily INPHOG clinical research trial activities for sponsored & academic studies, for assigned projects. To review and comprehend each assigned INPHOG protocol including study proceedings and timelines. Interviewing families/patients and collecting and entering data at one or more hospitals which are participating in the INPHOG study. Complete case report forms. Extracts data from patient file (Source documents) in a timely manner. Complete and accurate entry of all data collected into Data Entry Forms Developing relationships with key individuals in assigned hospital to ensure successful implementation of study including; doctors from all departments and other social support team members, hospital administration, etc. Work under close supervision of the primary delegate or reporting manager Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure protocols are followed and that there is timely documentation and submission of study data. To Complete Feasibility, To Conduct Site Selection Visit, To Maintain trial related Document, To Prepare Protocol, Dossier Submissions & Presentation for EC Coordinating with the sponsor, PI, legal & finance in order to finalise the CTA & Study Budgets. Subject Screening Activities, Maintain Source documentation, dispense IP and manage lab procedures. Conduct reminder calls, prepare for subject study visit, manage study subject’s reimbursements, AE & SAE reporting, Source Document Maintenance, Investigator Site File management, IP accountability & CRF Completion, completion of all study logs. Working with the sponsor monitors (CRA’s) during their monitoring visits. Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required. Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer. Promotes the ethical conduct of research by reporting in good faith any suspicions of misconduct in research. Any other activities deemed necessary by the primary delegate or reporting manager for the efficient conduct of the trial. COMPETENCIES/ SKILL SET: Excellent written and oral communication skills in English and regional language Proficient in use of computers (MS Office) and internet applications Counselling and mentorship skills Analytical and documentation skills Accepts and ensures rigor in program implementation Knowledge of biological and medical terminology. Understanding of the principles of administration and management. Prolonged periods of sitting at a desk and working on a computer. Understanding of research database How to Apply: Professionals meeting above requirements and with plans to associate with INPHOG for several years, may mail their CV to hr@inphog.org at the earliest. Please clearly mark the e-mail with subject line : “CRC Application”. Applications. The last date for applications is the 20th January, 2024. Contact Person: Prakash Tiwari Contact No: 9911523140

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Junior Drug Safety Associate Junior Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Bachelor of Physiotheraphy Show more Show less

Immediate Job Openings for our Pharma Clients Job Profile Quality Assurance, Quality Control , CRA , R & D , Pharmacist , Medical Claims , Medical Record summarization , Medical Billing , Medical Writer , BDM , CDM , RA Production ,

Job Title: Pharmacist Company Name: Manipal Hospitals Job Description: Manipal Hospitals is seeking a dedicated and knowledgeable Pharmacist to join our healthcare team. The ideal candidate will be responsible for ensuring the safe and effective use of medications for our patients. Roles and Responsibilities Roles and Responsibilities: 1. Dispense medications and ensure the accuracy of prescriptions provided by healthcare professionals. 2. Counsel patients on the proper use of medications, potential side effects, and drug interactions. 3. Collaborate with doctors, nurses, and other healthcare staff to optimize patient care and medication management. 4. Conduct medication reviews and maintain patient medication profiles to ensure safe and effective therapy. 5. Monitor and manage the inventory of pharmaceuticals, ensuring adequate stock levels and proper storage conditions. 6. Provide drug information and education to both patients and healthcare professionals. 7. Participate in quality improvement initiatives and adhere to regulatory standards and hospital policies. 8. Maintain accurate and detailed records of all pharmacy activities, including prescriptions dispensed and medication errors. 9. Supervise pharmacy technicians and support staff in their daily tasks and responsibilities. 10. Stay updated on new medications and treatment protocols, continuing professional development. Qualifications: - Bachelor's degree in Pharmacy or Pharm.D. from an accredited institution. - Valid pharmacist license in the respective state. - Strong knowledge of pharmacology and pharmaceutical care practices

Senior Auditor, Quality Assurance- Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Auditor Quality Assurance to join our diverse and dynamic team. As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of in Native treatments and therapies. Job Location: Bangalore (Remote Based) Responsibilities And Qualifications Manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans. Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations. Lead/Support regulatory Inspection hosting Lead/Support Sponsor Audit Hosting Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management Manage Quality Issues Lead Quality Issue Investigations Supports Operations in Root Cause Analysis and CAPA Plan preparation. Support Effectiveness Check development and outcomes. Assist with the implementation and maintenance of an effective Quality Management System/ Quality Assurance program within the relevant Quality & Compliance (Q&C) team. Perform departmental and ICON staff training regarding ICON’s quality system, Q&C tasks and processes, applicable standards, and regulations. Mentor new or developing Q&C staff as assigned. Support business development activities and Q&C initiatives as needed. Host regulatory inspections of the site/ICON/Sponsor as Lead Host or Co-host Host Sponsor audit ICON as Lead Host or Co-host What You Will Have 5 years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare industry. Advanced knowledge of GCP (Good Clinical Practice) Excellent organizational skills. Must possess a technical knowledge that is applicable to clinical drug development. An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel). Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances. Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision Read, write and speak fluent English. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply Show more Show less

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Position Responsibilities Acts as the point of contact person with the Health Authority on safety related matters. Implementation and maintainace of Risk management plans Implementation and maintainace of Additional Risk Minimization Materials. Handel safety information related activities Identification of PV activities and implementation of SOPs Implementation of PV Audit and Inspection Readiness Development of training modules and organizing trainings Planning, processing and reporting of Aggregate Reports to HA Establishment and maintenance of Quality Management System (QMS) Implementation of Pharmacovigilance Agreements Collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases (as applicable) Submission of single cases from Clinical Trials to local Health Agencies (HA) and Ethics Committees as per requirement. Handel Local Market Safety Data Quality Implementation and maintainace of Local PSMF Degree Requirements University degree (B. Pharm, M. Pharm or Pharm D) or Medical Professional Experience 6-7 years experience of working in Regulatory, Clinical Operations or Medical Affairs ) within the pharmaceutical industry. Ideally having minimum 4 years of experience working in Pharmacovigilance . If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage your expertise in Generative AI to enhance drug safety processes. With a focus on innovation and precision you will contribute to the development of safer pharmaceutical products. This hybrid role offers a unique opportunity to work in a collaborative environment ensuring the well-being of patients worldwide. Responsibilities Utilize Generative AI to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting of adverse events. Collaborate with cross-functional teams to integrate AI-driven insights into pharmacovigilance workflows enhancing overall efficiency. Monitor and evaluate the safety profiles of pharmaceutical products identifying potential risks and recommending mitigation strategies. Develop and maintain comprehensive documentation of pharmacovigilance activities ensuring compliance with regulatory standards. Assist in the preparation of safety reports and risk assessments contributing to informed decision-making processes. Conduct thorough reviews of case processing data ensuring accuracy and completeness in all records. Support research and development initiatives by providing valuable insights derived from AI-driven data analysis. Participate in training sessions and workshops to stay updated on the latest advancements in pharmacovigilance and AI technologies. Communicate effectively with stakeholders providing clear and concise updates on safety-related findings and recommendations. Ensure adherence to company policies and industry regulations maintaining the highest standards of data integrity and confidentiality. Contribute to the continuous improvement of pharmacovigilance processes identifying opportunities for innovation and optimization. Collaborate with IT teams to implement and maintain AI tools and systems ensuring seamless integration with existing workflows. Engage in proactive problem-solving addressing challenges and obstacles with a solution-oriented mindset. Qualifications Possess a strong foundation in Generative AI with practical experience in applying AI techniques to pharmacovigilance data. Demonstrate familiarity with research and development processes particularly in the context of drug safety and efficacy. Exhibit proficiency in PV case processing with a keen eye for detail and accuracy in data management. Display excellent communication skills capable of conveying complex information to diverse audiences. Show a commitment to continuous learning staying abreast of emerging trends and technologies in pharmacovigilance. Demonstrate the ability to work effectively in a hybrid work model balancing remote and in-office responsibilities. Possess strong analytical skills with the ability to interpret and synthesize large volumes of data. Certifications Required Certification in Pharmacovigilance or AI-related field preferred. Show more Show less

Cognitio Analytics LLC is looking for Sr. Medical Coding Consultant to join our dynamic team and embark on a rewarding career journey. Undertake short-term or long-term projects to address a variety of issues and needs Meet with management or appropriate staff to understand their requirements Use interviews, surveys etc. to collect necessary data Conduct situational and data analysis to identify and understand a problem or issue Present and explain findings to appropriate executives Provide advice or suggestions for improvement according to objectives Formulate plans to implement recommendations and overcome objections Arrange for or provide training to people affected by change Evaluate the situation periodically and make adjustments when needed Replenish knowledge of industry, products and field

As an Associate Medical Director, Patient Safety Physician, you will be responsible for signal detection, evaluation risk management activities, and labeling. You will provide medical input into the identification and utilization of information sources for signal evaluation, collaborate with external providers, and discuss data evaluation results with key stakeholders. Your strategic input will be vital in regulatory requests and safety evaluation documents. Additionally, you will contribute to regulatory reports and submissions, participate in external meetings, and maintain readiness for audits or inspections. Your collaboration across functions and cultures will drive innovation and process improvement. Essential Skills/Experience: Medical degree (eg MD, MBBS) At least 2 years of clinical experience post-registration High level of medical competence, with an ability to balance this with industry standards to achieve business goals Minimum 3 years of Patient Safety experience (Pharmacovigilance) (with clear evidence of delivery) Total of 6 to 11 years of experience Desirable Skills/Experience: Able to work across TAs and Functions Experience of supervising Patient Safety colleagues A demonstrated ability to understand epidemiological data Skills and Capabilities: Commitment to Customers and Integrity Strategic Leadership Acts Decisively Drives Accountability Works Collaboratively Develops People and Organisation May train or mentor junior level staff within given role Technical: Drug Development Experience and Application of Disease and TA knowledge Integrative thinking Excellence in pharmacovigilance Patient Benefit risk assessment Core: Conceptual thinking Influencing Initiative Innovation Business relationship management

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do 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 Junior Drug Safety AssociateJunior Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Physiotheraphy

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLAs defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers and clients business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completed Mandatory Skills: Pharmacovigilance & Drug Safety(Pharma).

KASHI INSTITUTE OF TECHNOLOGY is looking for Senior Research Assistant (SRA) / Research Assistant ( RA) to join our dynamic team and embark on a rewarding career journey Conduct Research: Design and execute experiments or research projects under the guidance of senior researchers or project leaders. Collect, analyze, and interpret data using various research methodologies and tools. Literature Review: Review relevant literature to understand the current state of knowledge in the research area. Stay updated on advancements in the field and incorporate relevant findings into ongoing research. Data Collection and Analysis: Utilize appropriate techniques to gather data, whether through experiments, surveys, interviews, or other methods. Analyze and interpret data using statistical methods or other relevant analytical approaches. Report Writing: Prepare detailed reports summarizing research findings, methodologies, and conclusions. Contribute to the writing of research papers, articles, and presentations for conferences or publications. Collaboration: Work closely with team members, senior researchers, and other stakeholders to achieve research goals. Participate in research meetings, seminars, and conferences. Equipment and Lab Maintenance: Maintain and operate laboratory equipment as needed. Ensure proper documentation and organization of research materials. Compliance and Ethics: Adhere to ethical guidelines and standards in research activities. Ensure compliance with relevant regulations and protocols.

JOB DESCRIPTION As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy.To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute & plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment.You have a very important role to play in Division's success.Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business.Plan demand generation and fulfillmentMonitor actual Sales and mid-course corrections and inputs to reduce variance against expectationsPrescription audit for Abbott brands and other competitors brandsTo create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format.Business generation & development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business planHaving science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist placeOrganizing Camps (CME) as per the division strategy and customers needExecute the customer management plan to ensure that all the customers are covered as per the plan.Lead and execute strict adherence to Abbott Code of Business conductSet examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure complianceDemonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and EnduringEnsure a high level of customer service and manage any difficult customer situations.Division and business strategy will be shared with you on time to time base which you will have to execute to the fullestTo attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image.Meet minimum KPIs as follows: 100% coverage of Doctors.Customer Call average as per the customer management plan of the division /therapy.Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division.Experience/Training Required2+ Years of experience.Candidate with prior/current experience in the same therapy.Candidates from MNC and top Indian Pharma companies will have added advantages.Fluent and confident in communication.#LI-DNI

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications and experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Summary Position Summary Title:- Consultant/Sr. Consultant – Life Sciences IT Quality Deloitte’s Life Sciences IT Quality practice is targeted at the life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to IT Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. The position provides excellent opportunity to: Identify and manage regulatory risks to support client in regulatory compliance, governance and controls Lead and coordinate cross-functional project teams for new product development and other validation projectsto include reviews, risk analysis and other QA activities in support of systems development and manufacture Assist client in developing strategies for process improvement which caters to the needs of the qualityorganization Author validation strategies and other plans/protocols and summary reports (end-to-end computerized systemvalidation experience is mandatory) Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and QualityAssurance groups to assure successful project execution and end-user training Plan, manage and execute as needed, installation, operational and performance qualifications in accordancewith current Good Manufacturing Practices (cGMPs) Review and approve validation lifecycle documentation Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions Provide Quality review and assessment of associated change requests related to processes, IT infrastructure,equipments and computer systems?Manage project governance, including providing progress updates of the assigned deliverables, driving timelyclosures of escalations and facilitating strategic decisions with senior management. Initiate trainings and workshops for knowledge transfer and competence building The Team Deloitte's R&OR Life Sciences and Healthcare advisory team combines a broad range of skills providing tailored validation services that addresses regulatory compliance (GxP, Part 11) and, governance and control of process, people and technology. R&OR LSHC practice provides organizations with complete spectrum of services helping them embrace change, grow their business, and emerge resilient following periods of change and disruption. Qualifications And Experience Required : Bachelor’s degree (or equivalent) 2.5 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance Experience in systems validation and quality frameworks Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) Hands on project management skills managing medium to large projects with end-to-end validation experience Clear understanding of principles, procedures and governance of validation activities. About Deloitte Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms. Copyright © 2017 Deloitte Development LLC. All rights reserved. Demonstrated analytical and problem solving skills Demonstrated ability to create and direct proposal, and presentation effort Excellent written and oral communication skills. Motivation and skills to work in a team-oriented environment and a desire to work in a company that places high value on cooperation and group achievement Preferred: Master’s Degree In-depth knowledge of pharma and medical device quality systems including design control and manufacturing processes. Understanding of risk management and its application in design and quality systems. #CA-VT Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients' most complex challenges. This makes Deloitte one of the most rewarding places to work. Our purpose Deloitte’s purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Professional development From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Requisition code: 303484 Show more Show less

Medical Coding is the process of converting Verbal Descriptions into numeric or alpha numeric by using ICD 10-CM, CPT && HCPCS. As per HIPAA rules healthcare providers need efficient Medical Coders. Qualification & Specifications : MBBS,BDS,BHMS,BAMS,BSMS,PHARMACYB.Sc/M.Sc (Life Sciences / Biology / Bio Chemistry / Micro Biology / Nursing / Bio Technology), B.P.T, B.E BIOMEDIAL, B.Tech (Biotechnology/Bio Chemistry). 2018 -2024 passed out Skills Required: * Candidates should have Good Communication & Analytical Skills and should be Good at Medical Terminology (Physiology & Anatomy). Role: To review US medical records Initial file review for identifying merits Subjective review and analysis to identify instances of negligence, factors contributing to it To review surgical procedures, pre and post-surgical care, nursing home negligence To prepare medical submissions To prepare the medical malpractice case Regards Pujitha +917200052460