1738 Pharmacovigilance Jobs - Page 19

Job Title: Executive - Pharmacovigilance Job Location: At HO - Thaltej, Ahmedabad Responsibilities : Handling Pharmacovigilance functions for domestic and international business Managing regulatory audits and related activities related to PV compliance Medical training to Sales and Marketing mainly related to PV Supporting medico-marketing activities as per the need Designing and executing various kinds of clinical studies for data generation Qualification : Pharm D, M.Pharm, PhD

*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Gandhinagar / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com

Job Title: Senior Medical Safety Advisor Education Qualification: MBBS/MD. Work Location: Anywhere in India. Work Mode: Home Based. Years of exp: 3yrs Clinical and 2+ yrs of PV (Exp in Oncology is a must) Pls note MCI reg is mandatory for all the foreign medical graduates. Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and standalone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a products safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings • Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverages for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects • 24-hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Qualifications Required MBBS/MD graduates from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Three (3) years of clinical practice experience with 2+ additional years in the pharmaceutical or associated industry in any role is required. Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice. Knowledge of clinical trials and pharmaceutical research process. Ability to establish and meet priorities, deadlines, and objectives. Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility. Ability to establish and maintain effective working relationships with coworkers, managers and clients. A valid medical license, or equivalent, from the country or region in which he/she resides and works Preferred.

Position: HR Specialist – Compensation & Benefits (Freelance) Location: Remote (India-based) Contract Type: Freelance / Consultant (Open to other flexible arrangements) About Us :Alphanumeri c is a global company founded in 1979, with operations across the US, Canada, Brazil, Colombia, Poland, Portugal, UK, France, Spain, India, and the Philippines. We specialize in supporting some of the world’s leading pharmaceutical companies by delivering pharmacy consulting services (patient engagement, contact centers, medical communication, regulatory compliance, safety and pharmacovigilance), IT solutions and workforce management strategies .Our mission is to enhance the patient and provider journey through personalized, tech-enabled communication and operational excellence. We also collaborate with clients in other sectors, including automotive and commercial airline, to deliver tailored project solutions .One example of our impact: during the COVID-19 pandemic, we built a global support team for one of our main clients, including healthcare professionals, IT experts, WFM analysts, and customer service specialists, to assist at every stage of the vaccination rollout . Role Overvie w:We are seeking an experience d HR Speciali st with a strong focus o n Compensation and Benefi ts in the Indian market. The ideal candidate will have a solid understanding of local labor laws, market benchmarks, and cost structures, and will be able to craft compelling offers that align with our talent acquisition goals. While the primary focus is on C&B, experience i n recruitme nt is a valuable asse t. Key Responsibiliti es:Conduct regular job evaluation to ensure accurate job classifications and competitive salary rang es.Conduct data analysis and generate reports related to compensation and benefits to support management decision-maki ng.Develop and implement competitive compensation strategies aligned with company goals and market tren ds.Maintain a consistent pay philosophy for all employe es.Design and implement compensation structures tailored to different roles and seniority leve ls.Analyze market trends and benchmark salaries and benefits to ensure competitivene ss.Calculate and propose salary packages, bonuses, and benefits based on multiple variables (e.g., location, experience, contract typ e).Advise on statutory compliance related to compensation (e.g., PF, ESI, gratuity, tax implication s).Support the recruitment team by providing compensation insights and helping craft attractive offe rs.Collaborate with leadership to develop compensation strategies for freelancers, contractors, and full-time employe es.Maintain up-to-date knowledge of labor laws and compensation regulations in Ind ia. Requireme nts:Proven experience (5+ years) in Compensation & Benefits within In dia.Strong analytical skills and proficiency in compensation modeling and salary benchmark ing.Familiarity with Indian labor laws and statutory benef its.Experience working with or supporting recruitment te ams.Excellent communication and stakeholder management ski lls.Comfortable working independently in a remote, freelance capac ity. Preferred Qualificat ions:Experience working with international compa nies.Knowledge of HRIS or compensation management t ools.Ability to work across multiple time zones and adapt to a fast-paced environ ment.Experience in recruitment is a valuable a sset. What We Offer:Flexible working hours and remote setup.Opportunity to shape compensation strategy in a growing co mpany.Collaborative and inclusive work cu lture.Competitive freelance compens ation.

BR EN FR Follow us Home Submit speculative application Searches, alerts You are here : Home › Vacancy list › Vacancy details Selection: 0 vacancy(s) Follow us Menu Careers website SEPTODONT Home Submit speculative application Searches, alerts SEPTODONT vacancy search engine Job locationPlease select a value Asia (2) India (2) Taloja (2) Europe (48) France (47) Saint-Maur-des-Fossés (22) Paris (18) Croissy Beaubourg (7) North America (16) Canada (13) Cambridge (13) USA (3) Lancaster, PA (3) Brazil (3) Brazil (3) Catanduva (1) Pomerode (2) CategoryPlease select a value Business Partner Functions (10) Administrative (1) Finance (4) IT (5) Operations (18) Engineering (1) Maintenance (2) Manufacturing (5) Project Management (1) Supply Chain (4) Technical Services (5) Quality / HSE (14) Health & Safety (1) Quality Assurance (7) Quality Control (6) Sales & Marketing (11) Marketing (5) Sales (6) Scientific (16) Medical Affairs (2) Pharmacovigilance (2) R & D (3) Regulatory Affairs (9) Contract typePlease select a valueAlternance (21)Contract (10)Permanent (38) View all vacancies RSS and other feeds " id="ctl00_ctl00_ctl07_defaultValidationSummary" class="ts-notification ts-notification--global ts-notification--info ts-notification--add-cross erreur clearfix" data-valsummary="true" style="color:Red;display:none;"> National Sales Manager M/F 2 / 69 vacancy Vacancy details Position description Category Sales & Marketing - Sales Job Title National Sales Manager M/F Job Summary Create, Lead and execute National Sales Strategy growth for Septodont India by fostering a high-performance culture, ensuring customer-centricity, and delivering consistent business outcomes through effective people and dealer management. Responsibilities Strategic Sales Leadership Develop and execute national sales strategy, set region-wise targets, analyze market trends, and identify newer avenues for growth . Build strong relationships with KOLs, KBL’s, channel partners; maintain high stakeholder engagement. Continue to Provide market insights, competitor analysis, and performance updates - Future market trends in dental industry, through regular field visits and interactions. Identify untapped markets and build a plan for market penetration. Sales Operations & Field Control Ensure effective implementation of strategies, maximize productivity by headcount, monitor field execution and drive adoption or conversions. Inventory & Financial Oversight Inventory planning at designated warehouses for Imported and MII products basis trends and sales forecast; ensure timely collections and remittances for healthy cash flow. Digital Sales & Innovation Drive digital adoption (CRM, data analytics), align sales campaigns with marketing, stay updated on dental market trends. Incentive & Budget Planning Design sales incentive programs within budget; evaluate ROI of trade exhibitions and other market driven activities. Compliance & Ethical Standards Ensure adherence to Septodont Code of Conduct across all actions. Team Management & Development Lead, coach, and develop sales teams; foster a high-performance culture and succession planning. Qualifications MBA/PGDM in Sales, Marketing, or Business Management or relevant field. 15+ years in sales within Medical Devices, Pharma, or Healthcare; 4+ years in national sales leadership. Key Skills: Strategic Sales Planning, People Leadership, CRM & Analytics Proficiency, Market Insights & Development, Stakeholder Management, Adaptability, Execution Excellence, Customer Realtionship. Contract type Permanent Candidate criteria Minimum Level Of Experience Required Over 10 years Languages English (2- Business fluent) Position location Job location Asia, India, Taloja Location C-1/2, MIDC Industrial Area,Taloja, Tal, Panve 410208 Maharashtra General information Reference 2025-2143 Legal notices Cookies Configure your cookies Accessibility: partial compliance Sitemap Go to top

BR EN FR Follow us Home Submit speculative application Searches, alerts You are here : Home › Vacancy list › Vacancy details Selection: 0 vacancy(s) Follow us Menu Careers website SEPTODONT Home Submit speculative application Searches, alerts SEPTODONT vacancy search engine Job locationPlease select a value Asia (2) India (2) Taloja (2) Europe (48) France (47) Saint-Maur-des-Fossés (22) Paris (18) Croissy Beaubourg (7) North America (16) Canada (13) Cambridge (13) USA (3) Lancaster, PA (3) Brazil (3) Brazil (3) Catanduva (1) Pomerode (2) CategoryPlease select a value Business Partner Functions (10) Administrative (1) Finance (4) IT (5) Operations (18) Engineering (1) Maintenance (2) Manufacturing (5) Project Management (1) Supply Chain (4) Technical Services (5) Quality / HSE (14) Health & Safety (1) Quality Assurance (7) Quality Control (6) Sales & Marketing (11) Marketing (5) Sales (6) Scientific (16) Medical Affairs (2) Pharmacovigilance (2) R & D (3) Regulatory Affairs (9) Contract typePlease select a valueAlternance (21)Contract (10)Permanent (38) View all vacancies RSS and other feeds " id="ctl00_ctl00_ctl07_defaultValidationSummary" class="ts-notification ts-notification--global ts-notification--info ts-notification--add-cross erreur clearfix" data-valsummary="true" style="color:Red;display:none;"> Professional Services (Dental Division) M/F 1 / 69 vacancy Vacancy details Position description Category Sales & Marketing - Marketing Job Title Professional Services (Dental Division) M/F Job Summary The Manager – Professional Services is a clinically qualified expert responsible for building clinical advocacy, delivering product education, and supporting the sales teams through scientific engagement and strategic data insights. This role also involves leveraging market data and clinical trends to shape product positioning, training strategies, and customer engagement plans. Responsibilities Clinical Education & Training: Plan and execute clinical training initiatives (workshops, webinars, Table Clinic) for dental professionals. Develop and deliver internal training programs for the sales teams. Create clinical content, including treatment protocols, technique guides, and educational videos. KOL Engagement & Relationship Management Identify, develop, and manage a network of KOLs and academic & digital influencers. Facilitate scientific collaborations, speaker programs, and peer-to-peer learning forums aligned to Sales Strategy and working closely and in coordination with the Sales team. Support clinical validation and documentation through user trials and case studies in coordination with the Sales team. Scientific & Clinical Support Act as a key resource for technical/clinical queries from internal teams and customers. Assist in product evaluations, chairside support, and troubleshooting in coordination with the Sales team . Data Analysis & Clinical Insights Analyze customer feedback, usage patterns, product performance, and clinical outcomes to support continuous improvement. Compile data from field activities, workshops, and trials into actionable insights. Track industry trends, competitor data, and market intelligence to guide product positioning and strategic decisions. Marketing & Commercial Support Work closely with the marketing team to develop clinical messaging, value propositions, and campaign content. Contribute to product launch planning with clinical input and field training support. Support development of marketing collateral such as brochures, videos, testimonials, and clinical decks. Participate in strategic planning by contributing clinical perspectives to segmentation, targeting, and content strategy. Event & Conference Management Represent the company at dental conferences, exhibitions, and academic forums along with the Sales team. Support planning and execution of scientific symposia, continuing education events, and product launches aligned with the sales team. Qualifications BDS or MDS (preferred in Endodontics, Prosthodontics, Pediatric dentistry or Conservative Dentistry). Upto 6 years of experience in dentistry and/or the dental industry, ideally with exposure to training, KOL engagement, or marketing. Strong analytical mindset with ability to translate data into clinical and business strategies. Excellent communication, presentation, and stakeholder management skills. Contract type Permanent Candidate criteria Minimum Level Of Education Required 3- Bachelor Minimum Level Of Experience Required 2-5 years Languages English (2- Business fluent) Position location Job location Asia, India, Taloja General information Reference 2025-2144 Legal notices Cookies Configure your cookies Accessibility: partial compliance Sitemap Go to top

Department – Rare Disease - Marketing- Early Launches Location - Hyderabad Novo Nordisk India Private Limited Are you an experienced medical professional and passionate about Clinical MedicalDoes being part of a growing, yet dynamic environment excite youIf yes, then you may be the one we are looking for as Clinical Medical Manager for Novo Nordisk India. Apply now! The position As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research center’s within the relevant therapy areas. Collect early scientific insights and guidance by discussing relevant early development data with external medical and scientific experts. Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations. Provide timely medical guidance and internal training to clinical staff. Engage in extensive scientific communication both internally and externally, requiring strong presentation skills. Performing ad hoc visits, Supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials and engaging key investigators to communicate trial results. Qualifications To be successful in this role, you should have the following qualifications: MD in any discipline with a strong clinical research/medical affairs background. 5 years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs, or pharmaceutical industry. Expertise in therapeutic areas of relevance (CVD, CKD, NASH), preferably with authorship in peer-reviewed journals. Understanding of pharmaceutical drug development. Open to domestic and international travel in connection with site visits, congresses, and company events. Experience as a clinical trial investigator or sub-investigator. Understanding the specificities and nuances of the local healthcare infrastructure. About the department The CMR (Clinical, Medical, Regulatory & Pharmacovigilance) team based in Bangalore. Our team is dedicated to driving clinical trials and providing medical/scientific expertise in New Therapy Areas. We work closely with KOLs, independent professional associations, and patient advocacy associations to ensure the successful execution of clinical trials. The atmosphere is collaborative and dynamic, with a strong focus on scientific excellence and patient outcomes.

Pharmacovigilance/ Sr Pharmacovigilance Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Roles & Responsibilities Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products. Generates data listings from the safety database and assumes responsibility for accuracy of the data. Complete adverse event follow-up in writing and/or by phone based on requirements for each Client. Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files* Perform safety review of clinical and diagnostic data as part of case processing. Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project. Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER Support Qualified Person for Pharmacovigilance as required. Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues. Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate. Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable) Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings. Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks. Supports interim data analysis for DMC reviews. Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process. Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines. Supports Safety Scientist in signal detection and risk management activities. Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately. Proposes solutions for procedural and technical issues. Supports audits and inspections as required for the assigned projects. Perform other activities as identified and requested by management including but not limited to: Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON. What You Will Be Doing Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. Conducting signal detection and risk assessment activities to identify potential safety issues. Collaborating with cross-functional teams to support safety-related inquiries and investigations. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. Assisting in the preparation of safety reports and regulatory submissions. Your Profile Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment. Strong analytical skills with attention to detail in data collection and reporting. Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. 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

Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process Digital Journey"s new initiatives features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

Kenvue is currently recruiting for a: Manager, , Global Aggregate Reporting and Risk Management What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. Role reports to: Associate Director GARRM Team Lead Location: Asia Pacific, India, Maharashtra, Greater Mumbai Work Location: Fully Onsite What you will do Kenvue is currently recruiting for: Manager, Global Aggregate Reporting and Risk Management (GARRM) This position reports into the Associate Director, GARRM Team Lead and is based in Mumbai, India. Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. Role reports to: Associate Director, GARRM Team Lead Location: Mumbai, India Travel %: 10 What you will do The Manager, Global Aggregate Reporting and Risk Management (GARRM) will be responsible for core safety deliverables including scheduled aggregate reports, Risk Management Plans (RMPs) and Company Core Data Sheets (CCDS) and will serve as the report owner for assigned reports within Medical Safety for Kenvue products. The Manager is an aggregate reporting expert and will have in-depth product knowledge to support daily activities including planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, project management/coordination of strategic safety documents, and oversight of deliverables produced by other team members. The Manager provides subject matter expertise and technical guidance on functional requirements and enhancements to meet emerging global regulatory requirements and implementation of global aggregate reporting solutions and training, monitors compliance metrics and implements corrective and preventative actions to remediate non-conformance issues. She/he will partner with team members, stakeholders including Global Risk Assessment and Safety Physicians (GRASPs), Qualified Person for Pharmacovigilance (QPPV), Signal Detection and Management (SDM), Global Case Management (GCM), Epidemiology, Regulatory Affairs, Clinical, Medical Affairs, Global PV System Operations (GPSO), Local Pharmacovigilance (LPV), and contracted vendor organizations. Key Responsibilities Ensure timely, quality reports/safety analyses related to core deliverables as appropriate: Collaborate with GRASP, QPPV (where applicable), and other stakeholders on strategy development Provide oversight of staff involved in aggregate reporting Develop quality systems and procedures for the aggregate analysis and reporting of adverse effects related to Consumer products, to assure regulatory compliance with company standards and regulatory requirements Initiate/Conduct/Oversee searches of internal and external databases Perform management review of all vendor-produced materials (e.g. draft reports and assessment responses); and/or lead aggregate safety analysis and case level review Author, contribute, and coordinate the preparation of core safety deliverables Prepares global aggregate reports for local authorities Ensure compliance (quality, procedures, regulations, consistency) and commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met, where applicable Partner with vendor to develop reports/deliverables Develop and maintain global pharmacovigilance aggregate reporting processes and procedures in compliance with regulatory requirements. Lead and manage a team of pharmacovigilance professionals to ensure timely and accurate submission of aggregate reports. Collaborate with cross-functional teams to ensure timely and accurate data collection and analysis for aggregate reporting. Stay up-to-date with regulatory changes and industry trends related to pharmacovigilance aggregate reporting and implement necessary changes to processes and procedures. Develop and maintain systems, tools and processes for drug safety operations. Participate and/or lead cross-functional training of relevant stakeholders and colleagues. Act as product or process Subject Matter Expert (SME) during audits/inspections. Daily management of vendor activities and responsibility for compliance with SOPs/WIs, global regulations/guidelines by either onsite or offshore resources. Performs training, onboarding, and oversight of offshore vendor. Participate or lead department and/or cross-functional initiatives. Contributes metrics and ensures quality, compliance, and timeliness of aggregate safety reports. What we are looking for Required Qualifications Bachelor’s degree required (health/life sciences field) 10 years of experience in the pharmaceutical or related industry with 5 years of experience in Pharmacovigilance Proven experience working in matrix environment and cross-functional teams Comprehensive clinical/medical writing experience Strong English verbal and written communication skills Strong knowledge of global pharmacovigilance regulations and guidelines (i.e., ICH, GVP, etc.). Ability to work collaboratively with cross-functional teams. Strong analytical and problem-solving skills. Desired Qualifications Advanced degree (e.g., MS, MPH, MSN, PharmD, RPh, PhD, etc.) preferred Strong leadership and presentation skills. Experience in developing and implementing drug safety policies and operating procedures. Ability to work in a fast-paced environment and manage multiple projects simultaneously. SME with in-depth product knowledge of assigned products; knowledge and hand-on experience in aggregate reports writing and compliance management. In-depth working knowledge of AE safety databases to identify system enhancements and efficiencies. What’s in it for you Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More! Learning & Development Opportunities Employee Resource Groups This list could vary based on location/region Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Job title: Expert Quality Services (Product Complaints) Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main responsibilities: Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. About you: Experience: 6 - 10 years of related experience in the pharmaceutical industry. Knowledge of cGMP s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. Languages: Verbal and written fluency in English Why choose us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

The position is responsible for the medical and scientific support, including technical advice to the Business Units and Pharmacovigilance/ Medical Information and Clinical Research teams in their assigned therapeutic areas This is crucial in view of the complex marketing environment in India due to the presence of generic players and self-pay nature of the market The position holder oversees the Medical Affairs function in India in their assigned therapeutic/product areas and cooperates with (if applicable) Regional Medical Affairs functions and relevant Global Medical Affairs functions This position holder is responsible for ensuring that marketing and sales functions have appropriate medical scientific support and training (the latter in co-operation with the Training department) To enable this support, product and development project information is to be kept up to date based on internal publications and communication with regional and global Medical Affairs functions as we'll as based on review of pertinent scientific publications In addition to this, the position holder is responsible for the review process of promotional materials in the respective area according to the global SOP and local laws and compliance The tasks also include monitoring of medical marketing activities of competitors locally and worldwide and close interaction especially with regional medical affairs functions The position holder will further support regulatory, PV/MI and CR teams in medical scientific questions and prepare and give internal (mainly marketing and sales functions) and possibly external presentations (local advisory board meetings, launch symposia and others) to enhance the medical knowledge of development projects and marketed products This also includes interaction and relationship-building with Thought Leaders (TLs Key HCPs) YOUR TASKS AND RESPONSIBILITIES: Medical Marketing Provide timely and appropriate medical review of all promotional material as we'll as challenging promotional activities of competitors where appropriate. Support development of marketing strategies with respective to competitor innovator and generic brands. Support BUs in transforming medical data into marketing strategy Work closely with other members of the medical team (especially the MSLs, if applicable) to support the business Build up good relationships with customers and TLs Build strong relationships with internal customers (marketing and sales) and with regional / global Medical Affairs Provide development project and product training internally to marketing and sales functions and externally to doctors and conduct refresher trainings at appropriate intervals. Support and educate internal customers in compliance with the Country s Code of Conduct Provide a comprehensive and proactive Medical service that encompasses, as appropriate, including Medical Support, Medical Information and Pharmacovigilance As Medical/Scientific Advisor, is responsible for overall medical inputs to Integrated Brand Plans of assigned therapeutic areas, provision of scientific expertise, review of promotional materials, thought leader management, speaker development and training. Takes responsibility for study development programs of the Business units within portfolio (included local studies OS, NIS, IIR). Identifies initiates and completes agreed study development activities in a timely manner, be IIR responsible of local IIR. Takes responsibility for all study development activities that they are running in accordance with all applicable external and internal regulations and guidelines. Play a role as local medical expert for Global Clinical Development by providing inputs for medical queries related to trials; participate in site feasibility. Respond to all external scientific and medical queries from physicians, regulatory authorities and public alike in an accurate, transparent and convincing manner in order to position Bayer as a credible, trustworthy and professional leader in the industry. Reviews all local patient support programs and other undertakings of the local organization with potential consequences on PV obligations (eg Market Research, Active-Online-Listening programs) to ensure Pharmacovigilance principles are applied in the interaction with patients. Develops, maintains and strengthens strategic partnership with relevant TLs, societies and associations. Act as medical contact for TL and external Medical experts. In collaboration with local marketing to develop, conduct Advisory Board meetings, Congress and Symposia. WHO YOU ARE: Graduate/ Post graduate degree (MBBS/MD) in life sciences is preferable. Experience and expertise in relevant TA s or in industry is preferable. Experience in driving and managing the medical strategy for various brands in the pharmaceutical industry. Clinical research and trial management experience, and be able to interact authoritatively with key stakeholders and investigators. Excellent presentation and teaching skills and to represent the company in a professional manner at medical, scientific and public events. Independent, self-driven, pro-active, extrovert and dynamic Ability to form relationships quickly and have demonstrable persuasive abilities Highly effective communicator both orally and in writing; can get ideas across one-on-in, in group settings as we'll as in presentations Strong team player and know how to collaborate and engage many stakeholders across a large organization Innovative and pro-active and has ability of strategic thinking Results-oriented attitude Experience in working with MS office in a Windows environment.

You ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What you will do Let s do this. Let s change the world. In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does. Data entry into Amgen s Quality System of approved audit responses Audit resourcing/planning Quarterly Investigator Site audit planning including identifying audit resourc es t hrough risk assessment of audit targets on a regular basi s Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits Updating Audi t tracking and accountability t ools and distrib uting/communicatin g all ocations to the audit teams Compiling Audit reporting metrics and communication Manage Audit documentation and filing Supporting outsourced audits by: Supporting outsourced audit resourcing/planning for Audits Provide necessary tools, reports/documentation, and access to systems for outsourced Audits Review initial draft audit reports, audit responses and debrief slides. Schedule and facilitate Quality Lead (pre-audit meetings) and audit debrief meetings QC Data entry into AMS of audit findings Confirming data entry into RDCS of approved audit responses Oversee timelines met for issuance of Initial audit reports; review of audit responses and issuing Final Audit Reports Provide guidance and resolve queries from external Audit vendors Weekly Meeting with external audit vendor to review tasks and status of audits Communicate noncompliance to Manager Administrative Support (includes maintaining & updating distribution lists and templates) Data entry/QC in to the Audit Management System (Trackwise) of audit findings Administrative support for audit resourcing/planning Manages Audit documentation and filing Ensures that the Audit Archive is updated with Final audit reports and closure memos and Plans/Agendas where applicable Follow up with CAPA Owners for completion dates and objective evidence Review and Append Objective evidence in Amgen s Quality System and close record What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek has a can do approach with these qualifications. Basic Qualifications: Master s degree in Life sciences or related field Preferred Qualifications: Minimum of 3-5 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility. Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. Quality Assurance Qualification/Certification (preferred)

About Amgen Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. About The Role The Digital Governance team supports the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence. They do this by managing the tracking and documentation of Amgen’s global digital sites and projects for compliance purposes. The Sr. Associate – Digital Governance will support the Digital Governance Business Process Owner (DSR BPO) in maintaining the accuracy of Amgen’s global digital site database. They are responsible for ensuring database records are kept up to date, responding to inquiries for database reports, following up on pending actions, and assisting users with process-related questions. This role will be on a flex shift to allow for live training and collaboration. Roles & Responsibilities: Support tracking and documentation of Amgen’s global digital sites and projects for compliance purposes Promote compliance for Amgen’s digital and social media asset inventory Provide guidance to inquiries regarding Amgen’s global digital database Assign training as needed to Amgen employees who manage or support digital assets Update formal process documents (SOPs, guidance/training documents) as needed Quality check digital assets against database information to ensure accuracy Follow up on overdue database task assignments Work with Domain Law to register Amgen URLs Support Digital Governance management in identifying areas of risk and concern Execute and document effectiveness checks Support corrective actions and regulatory inspections Maintain weekly and quarterly database reports Test digital site contact information to ensure compliance Provide Project Management support to key initiatives Maintain project management standards and methodology Provide change management support to key initiatives Required Knowledge and Skills: Deep knowledge of Veeva PromoMats database management processes Excellent written/oral communication skills and attention to detail Strong problem-solving skills and the ability to navigate complex situations Adaptability to assist in meeting urgent goals in a complex environment Familiarity with pharmaceutical regulatory compliance requirements (US and global) Experience with social media and website management Knowledge of Excel Ability to work collaboratively in a team environment Project Management Change Management Preferred Knowledge and Skills: Understanding of pharmaceutical regulatory compliance requirements in a global database environment Awareness of social media requirements and processes Basic Education and Experience: Master’s degree OR Bachelor’s degree and 3 years of related experience OR Associate’s degree and 5 years of related experience Preferred Education and Experience: Master’s or bachelor’s degree Experience working in a Global Regulatory Affairs or Pharmacovigilance organization AIN working hours for this position: This position supports the Regulatory Promotion and Material Compliance activities serving Amgen’s US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

At MetLife, we seek to make a meaningful impact in the lives of our customers and our communities. The Global Technology & Operations group (GTO) is a diverse team of engineers, developers, business analysts, claims analysts and project managers with the freedom to create innovative and solutions to address core business challenges with MetLife. This role will work with claimants, physicians, employers, and customers to ensure strict adherence in determining functional abilities. Provides recommendations regarding claimants current/potential functional abilities and develops goal-focused return-to-work plans. To apply, Call HR Nikita Grover at 8800307658 Job Responsibilities Provides professional medical, technical, consulting advice, and recommendations in support of claims evaluation, investigation, and assessment for various claims-related departments, while managing assigned caseload of complex case applying specialized training and knowledge to the assessment of cases and acting as a resource on clinical and technical issues. Conducts complex research, review and analysis of medical records, treatment plans and claim information. Provides recommendations regarding claimants current potential functional abilities and develops goal-focused return-to-work plans. Assess training needs and creates, authors, and presents medical training to claim and business partner associates. Engages claimants, healthcare providers, employers, and customers to ensure strict adherence in determining functional abilities. Engages claimants, health care providers and employers in return to work potential and planning while coaching claim specialists on identifying and acting upon return-to-work potential. Creates effective requests for medical information which focus on clarifying medical restrictions and limitations and their impact on work functionality. Performs other related duties as assigned or required Education, Technical Skills & Other Critical Requirement Bachelors degree (Medical) or diploma with a minimum of 15 years of education. Experience Current RN licensure 4+ years of experience as an RN with Clinical/Ops Experience Preferred 7+ years Disability claims and/or clinical experience. Disability claims experience Preferred designations CCM (certified case management) and/or CDMS (certified disability management specialist).

Job title : Project Specialist- Electronic Documentation Specialist (eDS) Location: Hyderabad Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally . Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. About The Job Our Team: The Global Hub is an internal resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. The Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations locally & globally. Main Responsibilities To ensure the format and submission-readiness validation of all documents that need to be prepared in the official electronic Document Management System (eDMS) such as clinical documents, CTD, PSMF, etc. Perform compilation/publishing of documents and implement navigation required to submit dossiers to Health Authorities. The eDS works in close collaboration with the teams responsible for the operational delivery of the documents. Essential Job duties and responsibilities: 1) Propose technical solutions based on previous experience and expertise gained within the eDS role. 2) Strong and thorough knowledge of MS WORD functionality and advanced skills in using Adobe Acrobat. 3) Organization and Prioritization: Organize and prioritize workload/multiple requests to comply with agreed-upon timelines and ensure that business needs are met. 4) Negotiation: Understand valid criteria for challenging various demands of users/customers. Be able to understand and identify priorities for the purpose of negotiating timelines. 5) Actively leads and develops Global Hub operations activities. 6) Ensure new technologies are leveraged. 7) Follow-up with the Medical Writers and other contributors for performing submission readiness. 8) Provide 1-1 support to authors/contributors and eDMS Users. 9) Participate in the review of eDMS-related guides, as appropriate. 10) Coordinate work that is subcontracted to vendors/CROs, providing technical support to vendors, seeking/identifying solutions, facilitating interaction and exchange of information, and overseeing/managing vendor activities. 11) Collaborates effectively with internal members of Clinical Documentation, such as medical writers and record managers, as well as contributors from other functional areas, including (but not limited to) Regulatory, Pharmacology, Statistics, Clinical Leaders, and Project Leaders. 12) If require, eDS may act as an alliance with the project specialist to learn and develop the end-to-end process through Datavision, Matrix, approval/compliance tools (e.g., PromoMats, NAYA), or any contracting database. People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) with an end objective to develop education and communication content as per the requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist medical regulatory writers in submission readiness activities, as required. Performance: 1) Ensure electronic documentation/publication materials are delivered and stored as per agreed timelines and quality. 2) Perform format and submission-readiness validation of clinical documents. Publish/compile clinical documents that consist of multiple components. 3) Create clinical documents and “binders” (as applicable) in the frim's eDMS. Ensure conformity of clinical documents (e.g., naming conventions, and metadata within the eDMS). 4) Set links within documents (internal) and publish/compile clinical documents (including CSR, CO, and Clinical Summaries) as required, including review and confirmation of the feasibility of publishing/compilation of Micro plans (timelines), monitoring the availability of appendices, performing format and submission-readiness validation on appendices, compiling all documents in the required/correct order and performing format and submission-readiness validation on the publishing/compilation. 5) Electronically approve, within the eDMS, all clinical documents. Process: 1) Support the delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports in the document management system/ approval-compliance. 2) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group. 3) Secure adherence to compliance procedures and internal/operational risk controls in accordance with all applicable regulatory standards. 4) Support Regulatory team in the contribution of submission-ready clinical documents for applications in electronic Common Technical Document (eCTD) format. 5) Support Medical Writers in the completion of the electronic Table of Contents (eTOC) dossier-planning spreadsheet. 6) Perform transversal activities, including identifying the need for eDMS user training, communicating the user needs, performing specific types of training, and participating in the development of new tools. Stakeholders: Liaise with the Medical department to prepare relevant & customized deliverables. About You Experience: 1-3 years of experience in the pharmaceuticals industry is preferred (electronic Documentation Specialist/ Project Management experience); Industry experience should be within comparable sectors or roles (computer systems, electronic document management systems/ project specialist role). Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills: As applicable (Including but not limited to Knowledge of Clinical development, submission dossiers and procedures preferred, Awareness of Specific software tools such as eDMS, Veeva Vault RIM, publishing tools, Acrobat (ISI Toolbox) and MS Office 365 environment are an added advantage) Education: Graduate / Post Graduate degree in life science preferred Languages: Communicate effectively both spoken and written Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Join us on our mission. Health. In your hands. www.opella.com/en/careers

Job Description: We are seeking an experienced and motivated Clinical Research Tutor/Trainer to join our academic team. The candidate will deliver engaging and industry-relevant training in clinical research methodologies, regulatory affairs, pharmacovigilance, and clinical trial operations. The candidate will also contribute to curriculum development, student mentorship, and practical training sessions to prepare students for careers in clinical research and related fields. Key Responsibilities: Deliver theoretical and practical training sessions on topics such as: Clinical trial phases and protocols Good Clinical Practice (GCP) guidelines Regulatory frameworks (FDA, EMA, ICH-GCP) Ethical considerations in clinical research Clinical data management and pharmacovigilance Design and update course materials, lesson plans, case studies, and assessment tools Conduct classroom and/or online sessions using modern teaching tools Guide students in research projects, internships, and dissertations Evaluate student performance through assignments, presentations, and exams. Collaborate with academic and industry professionals for curriculum improvement Organize seminars, workshops, and guest lectures with industry experts Maintain records of student progress and attendance Provide academic counseling and career guidance to students Stay updated with trends and developments in clinical research and regulatory science We are looking fora part-time clinical research tutor or trainer with the qualification background - B pharm, pharm d, life science, medical graduates and the salary will be 7500 rupees. Interested candidates share your resumes to iqctsplacement@gmail.com Job Type: Part-time Pay: From ₹7,500.00 per month Expected hours: No less than 10 per week Schedule: Day shift Experience: total work: 1 year (Preferred) Work Location: Remote

Job title: Expert Quality Services (Product Complaints) Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main responsibilities: Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. About you: Experience: 6 – 10 years of related experience in the pharmaceutical industry. Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. Languages: Verbal and written fluency in English Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.

As a Pharmacovigilance Specialist, your primary responsibility will be to manage safety reports and information for Aristo products in compliance with regulatory requirements. You will be involved in various aspects of pharmacovigilance activities including aggregate safety reports, individual safety case reports, and drug safety monitoring. In terms of Aggregate Safety Reports, you will need to have a thorough understanding of safety reporting processes and procedures. Your tasks will include authoring and reviewing reports such as PSUR & PBRER for submission to regulatory bodies in various countries. Additionally, you will be expected to develop and validate Risk Management Plans (RMP) for the assigned products, assess risk-benefit profiles, and ensure compliance with regulatory timelines. For Individual Safety Case Reports (ICSRs), you will be responsible for preparing ICSRs based on adverse reactions observed with Aristo products. This will involve appropriate case follow-up, information dissemination, and submission of ICSRs in the required format to regulatory authorities. In Drug Safety Monitoring, you will be managing day-to-day operational activities of the safety system, evaluating safety information, and monitoring the benefit-risk profile of Aristo products throughout their lifecycle. You will also provide support for adverse event and product complaint handling, interact with stakeholders for data collection, and assist in maintaining the Pharmacovigilance System Master File (PSMF). Furthermore, you will contribute to the development and updating of Standard Operating Procedures (SOPs) for the pharmacovigilance system, participate in CAPA processes, and support training activities related to pharmacovigilance. This is a full-time, permanent position that requires a Master's degree and a minimum of 5 years of experience in pharmacovigilance. The work location is in person, and the application deadline is 24/12/2024. Benefits include Provident Fund, and the schedule consists of day and morning shifts. If you are looking to utilize your expertise in pharmacovigilance and contribute to the safety monitoring of pharmaceutical products, this role offers a challenging and rewarding opportunity to make a significant impact.,

As a PSUR Specialist, your primary responsibility will be to author and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities. You will play a crucial role in ensuring the accuracy, completeness, and regulatory compliance of all PSURs. Additionally, you will be tasked with performing literature searches to gather relevant data for PSUR preparation and validating the information obtained to ensure accuracy. Your role will involve extracting and validating data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP). You will also be responsible for generating Line Listings (LL) from the safety database for inclusion in PSURs. Effective process management is key, as you will need to manage and reconcile relevant process trackers to ensure all activities are documented and on schedule. Providing reliable support for high-priority ad-hoc activities related to PSUR preparation will also be part of your daily tasks. Client interaction is an important aspect of this role, as you will communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies. It will be your responsibility to ensure that PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines. Furthermore, you will serve as a subject matter expert (SME) for PSUR preparation and review, providing training and mentoring to team members on PSUR-related processes and regulatory requirements. To excel in this role, you should hold a Bachelor's degree in a relevant scientific or medical field, with an advanced degree being preferred. Previous experience in pharmacovigilance, drug safety, or a related field, with a focus on PSUR preparation and review, is essential. Knowledge of regulatory requirements for PSURs/PBRERs, strong analytical and problem-solving skills, excellent written and verbal communication skills, proficiency in safety databases and data extraction/validation processes, as well as strong organizational skills are key qualifications needed for this position. Demonstrated ability to collaborate effectively with cross-functional teams and provide expert support will be critical for success in this role.,

Job title: Expert Quality Services (Product Complaints) Location: Hyderabad About The Job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs. Main Responsibilities Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. About You Experience: 6 – 10 years of related experience in the pharmaceutical industry. Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. Languages: Verbal and written fluency in English Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave. Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Main Responsibilities Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency. Essential Job duties and responsibilities: 1) Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s). 3) Adapts global scientific response documents for assigned countries. 4) Develops responses to escalated inquiries for assigned countries. 5) Develops contributions to US NDA Annual Reports. 6) Contributes to US compendia reviews. 7) Develops and maintains Therapeutic Area expertise. 8) Reviews the content created by peer writers. 9) Collaborates effectively with Global Medical Information teams to execute content plans People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise. Performance: Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality Process: 1) Act as an expert in the field of medical information writing and maintain on the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. About You Experience: >5 years of experience in medical writing for the pharmaceuticals/ healthcare industry or equivalent experience in a clinical setting; At least 2-3 years of direct medical information experience in a pharmaceutical company Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills, Knowledge about literature evaluation and multilevel response development) Education: Advanced degree in life sciences/ pharmacy/ similar discipline, or medical degree or doctorate degree (PharmD, Ph.D, Master in science, MBA or equivalent) Languages: Excellent knowledge of the English language (spoken and written) null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Role & responsibilities Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization. Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management. Manages projects where Safety and Pharmacovigilance are the primary services. o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. o Works with Finance to ensure appropriate customer invoicing, where required. o Approves project time cards and invoicing. o Provides sponsors with scheduled project updates and reports. o Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues. Participates in the management of the Safetyand Pharmacovigilance department with the following actions: o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. o Works with Business Development to actively solicit new business, as needed. o Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings. Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project. Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process. Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members Managing resourcing's needs/issues and escalating to senior management as necessary. Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions. Performs other work related duties as assigned. Minimal travel may be required. Qualifications - Must be a N3 or above certified (JLPT) Japanese Language professional - BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience Progressive responsibility with demonstrated leadership skills and project management Clinical Research Organization (CRO) experience with therapeutic specialties preferred Working knowledge of financial budgets and various financial analysis tools preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills Ability to establish effective relationships with clients as well as team members Ability to be flexible, adapt to change, work independently, as well as part of a teamin a matrix environment Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment

Job Description Field Manager, Technical This role is responsible for providing technical support to the concerned Zonal Sales team, by conducting technical training related to animal health and products to AFMs, organizing and participating in the technical seminars to field veterinarians & customers along with Sales team, attending the customer complaints, meeting Veterinary professionals of field and colleges for sharing of technical inputs, coordinating with VSD Corporate and Diagnostic laboratory in disease surveillance, customer requirements and field trials Our Veterinary team use their scientific background to provide technical expertise and education to our customers, sales and marketing teams. With a deep knowledge of pharmacology and animal health we engage scientific exchange with external experts and industry leaders ensuring the scientific value of our animal health portfolio is understood. Primary Responsibilities Include, But Are Not Limited To Providing Technical Services to customers in assigned geography (these services include on site customer visit along with Sales Team & off side telephonic support as well) Customer Meetings Meeting customers in a group to create awareness about relevant scientific practices and advancements with an objective to become a partner of choice among customers Special Focus on Key accounts / customers Collaborating with Key account managers and sales team to define key success areas in each key account and customer and developing and executing a comprehensive Tech service plan for maximizing our gains. Technical Up gradation of Sales team in assigned geography Staying ahead of curve for recent technical development in Poultry / Ruminant Industry and prepare internal competencies to provide customer support Maximizing our company’s Global Resources Strong Collaboration with Sr. Technical Manager to leverage Global technical resources Outbreak management Attend to, investigate outbreaks/customer complaints related to Poultry diseases as required within the business sphere and provide and counsel the customers for overall improvements. Peer feedback in the process is sent to relevant stakeholders. Supervising Local Clinical Trials and Market support studies in guidance of Sr. Tech Manager. Publication of Clinical Trials & Market Support Study Outcome in relevant peer reviewed Scientific Journals Supervise and provide timely and effective technical materials which maximize selling efforts. Assure that questions from customers are answered thoroughly and correctly in an accurate and timely fashion. Strong Collaboration with IDL Team for maximizing our diagnostic support to customers Collaboration with relevant Technical & Veterinary Education institutes in assigned geographies to further improve our image as Science Driven Organization Resource the useful technical articles from scientific fraternity for publishing the Blue Cross Book in order to the technical knowledge updating of the field veterinary staff. Any other relevant task which can help in improving business Pharmacovigilance Role Technical support to DPOC for PV cases Ensure PV compliance Qualifications & Skills Degree in Veterinary Sciences 2-3 years of field experience to handle all field situations and provide technical solutions to the customer needs Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species. Your role with us is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Who We Are … We have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Required Skills Preferred Skills Job Posting End Date 07/31/2025 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R336684

Job Title: Senior Clinical Research Trainer Advanced Level (Pharmacovigilance & Clinical Data Management Expert) Experience Required: 10+ years Location: Pune Employment Type: Full-time Salary Range: As per Industry Standard Job Summary: We are seeking an experienced and dynamic Senior Clinical Research Trainer to lead advanced training programs in clinical research domains including Pharmacovigilance (PV) , Clinical Data Management (CDM) , and Regulatory/Clinical Guidelines . The ideal candidate will have over 10 years of industry experience and a strong track record of mentoring professionals, designing curriculum, and ensuring industry-aligned learning outcomes. Key Responsibilities: Training Delivery & Development Design and deliver advanced-level training modules in Clinical Research, Pharmacovigilance , Clinical Data Management , and GCP, ICH, USFDA, EMA guidelines. Conduct both theoretical and hands-on training sessions using real-world case studies, tools, and systems (e.g., Argus, ArisG, iMedidata, eTMF, Viva Vault, Oracle Clinical, MedDRA, CDISC). Develop assessments, workshops, and continuous learning tools to measure trainee progress. Curriculum & Content Creation Regularly update training material based on evolving industry standards , regulatory changes , and best practices . Integrate mock projects and case-based scenarios to simulate real clinical research environments. Mentoring & Evaluation Mentor and support trainees pursuing careers in clinical research, PV, or CDM roles. Provide feedback and performance evaluations to ensure skill development and job readiness. Industry Collaboration Engage with clinical research organizations (CROs), hospitals, pharma companies, and academic partners for knowledge exchange, guest lectures, or internship support. Compliance & Quality Ensure all training adheres to GCP , 21 CFR Part 11 , ICH E6 , and company/industry SOPs . Curriculum Development & Training Delivery Create modular, outcome-based training sessions for various roles within clinical trials (e.g., CRCs, CRAs, investigators). Customize content for in-person and virtual formats, incorporating PV and CDM where relevant. Develop quizzes, case studies, and role-play exercises to enhance applied learning. Pharmacovigilance & CDM Integration Explain pharmacovigilance systems (e.g. E2B, MedDRA coding) and signal detection workflows to trainees. Provide hands-on guidance in adverse event reporting, causality assessments, and regulatory submissions. Train learners on clinical data lifecycle—from CRF design and eCRF tools to data validation and database lock. Regulatory & Compliance Coaching Teach ICH-GCP, Schedule Y, NDCT rules 2019, ICMR, ICH E6 and global trial protocols with emphasis on ethics and patient safety. Conduct sessions on regulatory documentation (e.g., IBs, protocols, SOPs). Keep trainees up-to-date with evolving guidelines (e.g. EU CTR, FDA CFR, CDSCO policies). Facilitation & Engagement Lead interactive discussions, practical demonstrations, and Q&A sessions to clarify complex topics. Mentor new trainers and support onboarding of junior clinical research staff. Encourage critical thinking and professional development through ongoing support. Evaluation & Feedback Assess trainee comprehension using structured tools like pre/post assessments and scenario analysis. Provide individualized feedback to learners and suggest learning pathways for skill enhancement. Analyze training effectiveness and recommend improvements to management. Qualifications Master's or PhD in Medical Sciences, Pharmacy, Life Sciences, or a related field. Minimum 10 years of professional experience in Clinical Research. Strong working knowledge of Pharmacovigilance and Clinical Data Management preferred. Proven track record of conducting successful training programs. Excellent communication and presentation skills. Ability to simplify complex concepts and engage learners at all levels. Key Requirements: Education: Master’s degree or higher in Pharmacy, Life Sciences, Clinical Research, or related field. Experience: 10+ years of professional experience in clinical research , with deep hands-on expertise in Pharmacovigilance and Clinical Data Management . Certifications Preferred: GCP Certification, PV/CDM Certification, or equivalent training credentials. Capable of handling interactive role-play and case-based scenarios. Attention to detail, adaptability, and team collaboration. Technical Skills: Tools: Oracle Argus , Oracle Clinical , MedDRA , WHO Drug , EDC systems (e.g., Medidata, Inform) Documentation: ICF, SOPs, SAE Reports, Data Clarification Forms (DCF) Guidelines: In-depth knowledge of ICH-GCP , FDA , EMA , and Schedule Y, NDCT 2019 Data Standards: Familiarity with CDISC , SDTM , ADaM Soft Skills: Excellent verbal and written communication Strong organizational and mentoring abilities Analytical thinking and problem-solving skills Ability to simplify complex concepts for diverse learners Preferred Qualities: Prior experience in corporate training , academic instruction , or clinical research consultancy Ability to create engaging e-learning content or lead LMS-driven programs Published work or conference presentations in the clinical research field is a plus