1759 Pharmacovigilance Jobs - Page 37

ROLE SUMMARY: The medical director provides Clinical Development leadership and expertise on clinical trials, including overseeing the design, conduct, and analysis. The medical director works closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, and patient advocacy groups. ROLE RESPONSIBILITIES: Study-level Clinical Development Leadership Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives. Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring. Lead peer-to-peer interactions with investigators. Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities. Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team. Strategic Guidance, Clinical Insights & Interpretation Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders. Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans. QUALIFICATIONS: Medical degree (MD) Relevant clinical or industry experience considered 2-5 years industry experience Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Ability to travel to relevant international scientific congresses and internal team meetings 3-6 times per year Work Location Assignment: Hybrid Work Location Assignment: Hybrid At Pfizer we care about our colleagues wellbeing and offer a range of great benefits for them, including: Paid parental leave Access to Health & Wellness apps Career Growth Experiences program Recognition & rewards program Paid volunteer days Life Insurance Benefits Pfizer Learning Academy access to top content providers Access to flu vaccines & skin checks Options to purchase additional leave Salary packaging & novated lease options *Benefits listed may vary depending on your position and location and may be subject to change. Pfizer Australia and New Zealand s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies. If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager. Medical #LI-PFE

Job title: Global Medical expert. Grade: NA. Hiring Manager: Head Scientific Communications/ Team lead. Location: Hyderabad/ Mumbai. % of travel expected: Travel required as per business need. Job type: Permanent and Full time. About The Job. Our Team:. Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.. Main Responsibilities. Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors. Essential Job duties and responsibilities: 1) Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. 2) Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. 3) Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). 4) Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. 5) Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. 6) Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams.. People: 1) Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement, 2) Interact effectively with stakeholders in medical and pharmacovigilance departments 3) Constantly assist the medical regulatory writing team in developing knowledge and sharing expertise. Performance: 1) Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality. Process: 1) Provide medical strategic insights & evaluation related to Sanofi’s portfolio. 2) Contribute to the management of the marketing authorization dossiers of the current related portfolio. 3) Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. 4) Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis 5) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region 6) Work with selected vendors when required within the region to deliver the required deliverables as per the defined process 7) Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery. Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables 2) Liaise with the Medical department to ensure relevant & customized are delivered per expectation. About You. Experience: ?5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areascardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine. Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment. Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills). Education: Medical degree MBBS; MD. Languages: Excellent knowledge of the English language (spoken and written). Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!. null. Show more Show less

Description. Regulatory Consultant (Sterile Experience). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Experience in regulatory submissions for sterile drug products, including aseptic and terminal sterilization processes.. Preparation and review of Module 3.2.P sections related to sterile manufacturing, microbial control, and container closure systems.. Post approval variation experience is mandatory for EU market.. Familiarity with EU Annex 1 requirements and its application in variation, renewal submissions.. Supports in preparation and peer review of regulatory submissions including variations, renewals, and responses to queries.. Handling post-approval changes related to sterile facilities, cleanroom classification, sterilization methods, and equipment upgrades.. Preparation of regulatory assessments and submission strategies specific to sterile dosage forms.. Reviews of media fill protocols, filter validation data, sterility assurance, and cleaning validation documentation for submission readiness.. Provides regulatory support during inspections and audits related to sterile manufacturing.. Change control assessments and preparation of regulatory impact summaries.. Day-to-day execution of tasks in accordance with client SOPs and regulatory standards for high-quality global CMC dossiers.. Collaboration with cross-functional teams including QA, QC (microbiology), validation, technical, analytical, and site functions for data collection and dossier preparation.. Secondary. Acts as a point of contact for coordination of documentation across functional teams to meet submission timelines.. Effective communication through email and calls with internal and client stakeholders for updates and clarifications.. Supports and mentors junior team members depending on project needs.. Hands-on experience with RIMS/Veeva Vault.. Open to working in cross-cultural and virtual team settings.. Qualifications. Minimum 6 years of experience required for regulatory submissions for sterile drug products with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Job Description:. Weekly Hours:. 40. Time Type:. Regular. Location:. IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge CityAdm: Argus Building, Sattva, Knowledge City. It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.. Show more Show less

We are seeking a highly analytical and strategic Senior Analyst to join our CI team, supporting business-critical decisions across the pharmaceutical product lifecycle.Key Responsibilities:Monitor and analyze competitor activities across pipeline, clinical trials, regulatory, commercial, and corporate developments in assigned therapeutic areas.Synthesize findings into clear, concise, and impactful deliverables such as landscape assessments, competitor profiles, war games, SWOT analyses, and executive briefings.Contribute to CI deliverables supporting brand planning, forecasting, launch readiness, and lifecycle management.Maintain and evolve CI processes, databases, and tools for improved efficiency and insight generation.Present insights to internal stakeholders and senior leadership with strategic recommendations. Qualifications Bachelors degree in a relevant field such as Life Sciences (Pharma, Biotechnology) Job Location

We are a company dedicated to the audit and certification of national and international standards of quality and sustainability in products and processes.. We have an interdisciplinary team of professionals specialized in each industry and sector, committed to providing the highest quality service in a personalized way, generating long-term relationships with our clients and the community.. Our wide service offer, our extensive network of producers, processors and traders, our presence in fairs and seminars in different countries and our growing internationalization, make LETIS a link to the world.. Brief Job Description:. Audit preparation. Audit report preparation. Responding to technical queries.. Sending Audit Packs to Certifying office within stated timeline. Submission of Updated Audit Logs. Technical accuracy as per guidelines of audits packs. Client Satisfaction. Sociable with good market recognition and understanding. Technical Knowledge on the food sector audited. Presentable with the right mix of authority and convincing capability. Analytical capability and prompt decision making capability. Qualifications:. Essential:. Graduate/ Post Graduate in careers related to Agronomy Engineering or registered Rural Administration Technician, etc.;. To have knowledge and skills in organic production and handling techniques. At least 2 years of experience as an organic inspector in another Certifying Body (preferably in NOP regulations). Intermediate-advanced level of English (B2-C1). Desirable:. Food industry work experience with knowledge/ experience in auditing food safety management systems. with good Communication Skills , pleasing personality and proficient in computer usage. Please note it is mandatory to attach an audit log of audits conducted during your career, as well as professional references.. Show more Show less

Description. Regulatory Associate (CMCPre and post approval ). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Assists with preparation of product development documents including gap analyses and clinical development plans.. Minimum 2 years of relevant experience. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. Qualifications. MS in science/healthcare field, or equivalent combination of education and experience.. Minimum 2 years of relevant experience. Excellent interpersonal / communication skills.. Advanced skills in Microsoft Office Applications.. Good time and project management skills, preferred.. Strong analytical skills and attention to detail.. Ability to work both as a team member and independently and to understand and carry out detailed instructions.. Ability to interact with staff from multiple departments.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

While technology is the heart of our business, a global and diverse culture is the heart of our success. We love our people and we take pride in catering them to a culture built on transparency, diversity, integrity, learning and growth. If working in an environment that encourages you to innovate and excel, not just in professional but personal life, interests you- you would enjoy your career with Quantiphi! Role: Associate Engagement Manager (Healthcare & Life Sciences) Experience Level: 6-9 Years Work Location: Mumbai, Bengaluru, Trivandrum Role & Responsibilities: Deliver successful projects across Healthcare and Life Sciences domains, including R&D, Clinical Development, Supply Chain, Quality, Regulatory & Compliance, Healthcare Provider Engagement, Population Health Management, Patient Experience, Digital Health, Marketing, Cost Reduction, Platform Implementation, and Automation. Serve as a Subject Matter Expert (SME) in Healthcare and Life Sciences, providing thought leadership and domain expertise to clients. Collaborate with internal teams and clients to define long-term vision, goals, and strategic roadmaps aligned with healthcare and life sciences priorities. Demonstrate strong consulting and advisory skills, analyzing complex information, synthesizing content, and translating insights into actionable recommendations and deliverables. Implement problem-solving procedures to enhance operational efficiency and effectively resolve client challenges. Develop and implement strategies to maximize customer satisfaction and strengthen client relationships in both healthcare and life sciences sectors. Communicate findings and ideas clearly and persuasively to stakeholders across clinical, operational, and executive levels. Exhibit a strong commercial mindset by optimizing deal pricing, contributing to revenue generation, and driving successful sales outcomes. Support team-building initiatives by recruiting, motivating, and fostering professional growth, with a strong focus on people development. Coach and mentor junior consultants in core consulting skills and healthcare & life sciences domains. Must have skills: 6-9 years of experience in management consulting or relevant roles within Healthcare and/or Life Sciences industries. Proven ability to manage multiple priorities with urgency, drive, and energy. In-depth understanding of healthcare and life sciences industry trends, regulations, and compliance standards. Hands-on experience in one or more of the following areas: Clinical Trials (protocol design, clinical data management, Trial Master File), Pharmacovigilance, Healthcare Provider Engagement, Supply Chain, Manufacturing, Analytics, Quality, Audit/Compliance, Connected Health, Digital Health Platforms. Familiarity with digital architecture, tools, technologies, and products relevant to healthcare and life sciences value chains. Strong analytical and problem-solving skills to decode complex business challenges and propose effective solutions. If you like wild growth and working with happy, enthusiastic over-achievers, youll enjoy your career with us !

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the team Oil & Gas This team is directly responsible for growth of Oil and Gas offline transactions & users at Paytm. About the role Team Leader To work with the business to understand and manage Programs being run for the Clients/Brands. And for accelerating the core growth metrics focusing on sales & distribution. Provides guidance and instruction to a working group about a project or portfolio of projects. These leaders are responsible for monitoring the efforts of the team members and getting the work done effectively and efficiently with the proper utilization of resources. Skills that will help you succeed in this role: 2+ yrs. of experience in Distribution sales in fintech, Banking/ Sales, EDC Sales. Develop plans and strategies for developing business and achieving the company's sales goals. Create a culture of success and ongoing business and goal achievement. Manage the sales teams and resources to deliver growth. Hire and build a new team to support our growing needs and future projects. Define optimal sales force structure. Define and coordinate sales training programs that enable staff to achieve their potential and support company sales objectives. Manage customer expectations and contribute to a high level of customer satisfaction. Define sales processes that drive desired sales outcomes and identify improvements. Going to the Merchant and educating him/her about the benefits of the Swipe machine (EDC) converting them and managing their accounts. Exceptional communication, presentation skills and relationship building skills. Ability to aggressively manage the successful execution of a sales strategy. Ability to work independently and collaboratively in a team environment. Qualifications: Bachelor's degree in business, marketing, or a related field (MBA preferred). Should have a strong understanding of the local language. Self-motivated and goal-oriented, with a demonstrated ability to work independently and as part of a team. Willingness to travel as needed to meet with clients and attend industry events.

Must have knowledge of documentation (COA, MSDS, VQ Filings , APQR, MOA,DMF) COA/ Certificate of Analysis • MSDS • Specifications/ TDS • Method of Analysis • Stability Data • DMF/ Drug Master File • Declarations Required Candidate profile Intrested Candidate Can share your CV in Whatsapp : 91-9724346949 / 9327657730

PV Reporting Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Pharmacovigilance Associate to join our diverse and dynamic team. As a Pharmacovigilance Associate at ICON, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. Your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. 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

Job title: Pharmacovigilance Audit and Inspection Readiness Expert 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 Main responsibilities: PV Inspection/ Audit & Training Support role is responsible for Participation in the ongoing permanent inspection preparedness and readiness of PV Operations in anticipation of regulatory inspections and audits. Active involvement in the preparation, conduct and follow-up of GxP regulatory inspections impacting PV Operations until closure. Active involvement in the organization of appropriate support for the preparation, conduct and follow-up of Global Quality audits impacting PV Operation activities, global PV processes/ tools or Business Partner audits, until closure. Responsible for Follow-up of audit/ inspections PV-related CAPAs to ensure timely completion and coordination of CAPA effectiveness reviews in collaboration with CAPA owners, as needed to prevent recurrence. Prepare for PV inspections/ audits from PV Operations perspective. Collaborate with countries for partner/ Global Quality Assurance (GQA) audit & HA inspection readiness. Facilitate development of responses to audit/ inspection findings where applicable. CAPA tracking for PV Operations related findings and coordinate activities to follow through completion. Deviation tracking for PV Operations Team and follow up with deviation owners for timely completion of deviation and related actions. Support PV Ops team to create and maintain training matrix for Case Management related activities for vendors and internal staff. Monitor training compliance for PV Ops team. Conduct PV focused mock inspections as per requirement. Conduct lessons learned meetings for PV Ops team as required from audit preparation perspective. Support PV Ops team with review of standard presentations for inspections and audits. Initiate and lead process improvements as needed pertaining to relevant audit, inspection preparation activities or training activities. Perform process gap assessment as required and implement risk registers. Create and maintain relevant SOPs, Job Aids, as needed. Other PV tasks as required. This role is responsible for ensuring audit and inspection preparedness, Audit/Inspection CAPA management, quality event/deviations management and CAPA effectiveness check monitoring. This position requires multiple interfaces with partners and customers within and outside of the Company This role involves understanding the constantly changing PV Regulations and ensuring that we follow them Experience About you: Experience in PV Databases like ARGUS, Aris-G (LSMV) VAULT Safety, etc. Overall 6+ years of experience, with minimum 3 years of pharmaceutical industry experience with a focus on pharmacovigilance audits and inspections Experience with PV audits/inspections management is must Experience in overseeing vendors responsible for case processing. Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GVP and GxP regarding systems validation and documentation Good knowledge of MS Office Strong experience with PV audits/inspection CAPA management Experience PV audits/inspection effectiveness check monitoring Experience with PV QMS systems and conducting PV mock audits. Experience overseeing PV training matrix and develop process if required Experience hosting PV inspection and audits Strong experience in ICSR quality review and submissions Incumbent should have experience in Process Improvement practices Soft Skills Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills. Excellent organizational and project management abilities. Strong communication and interpersonal skills. Ability to work effectively in a cross-functional, multicultural environment. Think strategically and lead teams. Problem Solving: Proactively identifying issues within processes, systems, or data, and taking the initiative to solve them or propose improvements. Excellent team-work and interpersonal skills Ability to work in cross-functional teams Excellent oral and written communication skills Excellent networking and influencing skills Technical Skills Regulatory Standards: In-depth knowledge of global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, ICH, and other health authorities. Knowledge of how adverse events are reported and classified (e.g., by severity, outcome) and the regulatory requirements surrounding these reports Safety Reporting Requirements: Knowledge of regulatory requirements for safety reporting (e.g., CIOMS forms, EudraVigilance, FDA REMS, etc.) and experience in ensuring compliance with these standards. Good Pharmacovigilance Practices (GxP): Familiarity with GxP guidelines, ensuring that all pharmacovigilance processes adhere to industry standards. Database Management: Familiarity with safety databases and systems (e.g., Aris-G / LSMV, Argus Safety, VigiBase, or similar systems) used for collecting, analyzing, and reporting adverse event data. Microsoft Office Suite: Advanced skills in Excel (for data analysis and reporting), Word (for report writing), and PowerPoint (for presenting findings). Presentation Skills: Proficiency in presenting findings to mid-level management, stakeholders, or regulatory bodies in a clear and impactful way Education Bachelor’s degree in pharmacy / Life Sciences / or equivalent Academic qualification is desirable with minimum 3 years’ experience in Global PV audits/inspections, CAPA Management, and PV risk analysis. 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

Our Team Sanofi Global Hub is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. Main Responsibilities Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews. Essential Job duties and responsibilities: 1) Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer. 2) Develops and maintains TA expertise. 3) Reviews content created by peers’ writers. 4) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned. 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 regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality Process: 1) Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis. 3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region. 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. 6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts. 7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution. Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables. About You Experience: >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality Technical skills: As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications) Performance: Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality Languages: Excellent knowledge of the English language (to read, write, and speak) null

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Drug Safety Associate Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts

Skill required: Pharmacovigilance Services - Medical Affairs Designation: Pharmacovigilance Services Specialist Qualifications: MBBS Years of Experience: 0 to 4 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Design, develop and deliver business solutions related to the medical affairs group of pharmaceutical companies, including thought leadership development, medical publications, education and information, medical grants, advisory boards and advocacy. What are we looking for? Ability to work well in a team Adaptable and flexible Agility for quick learning Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts MBBS

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Drug Safety Associate Drug Safety Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy,Master of Pharmacy

Jobsguru looking for a Medical Advisor for our pharma client in Mumbai. Contribute to the development of the medical components of the Brand Strategy and develop a Medical Plan. Mail CV search@jobsguru.in 9302574002 Shreya Jobsguru Consultant P Ltd Required Candidate profile Should be M. Pharma Excellent presentation and teaching skills Highly effective communicator both oral and written Can develop training material Excellent presentation and teaching skills

OVERALL MISSION: This position typically refers to any employee within the EPD Medical organization with medical/scientific qualifications and training who provides scientific/medical support to EPD in a non-sales capacity, where the provision of such scientific/medical support includes significant contact with Abbott customers in the field. This definition is not intended to apply to those employees whose primary job function relates to the monitoring or management of clinical studies. Reporting into the Senior Manager RMA / Head RMA this position participates in the initiation, oversight and follow-up of assigned clinical studies and medical projects initiated within the EPD Medical Organization, ensuring that activities are carried out in accordance with relevant processes and procedures. The RMA interfaces with other key members of the EPD Medical Organization - for example, Medical Managers, Clinical Research Managers and Medical Advisors - relevant to the therapeutic area for which the RMA has responsibility. The RMA assists relationships and advances the scientific credibility of the Company with established and emerging Regional/National Opinion leaders, responds to requests for scientific and medical information, and provides key scientific information updates to Regional and National Opinion leaders, as appropriate. The RMA develops, and maintains, key scientific knowledge that will enable credible dissemination of scientific information and informed scientific dialogue with physicians and opinion leaders, and the development of professional working relationships. JOB RESPONSIBILITIES: Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice. Provide scientific and technical support for, and help maintain professional and credible relationships with, key opinion leaders and academic centers to ensure access to current medical and scientific information on the products and areas of therapeutic interest. Ideate, design, develop and deliver innovative and engaging high science activities for Physicians and Key Opinion Leaders, to help drive Therapy Shaping in the area the RMA is assigned to, in collaboration with the Medical Affairs & the Commercial team. Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the relevant therapeutic area for which the RMA carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.): all activities to comply with applicable local laws, guidelines, codes of practice, SOPs, and, I& D * SOPs. Deliver high science, unbiased and accurate scientific presentations to physicians, individually or in groups (meetings, clinical sessions, etc.), when requested. Participate in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts - such as potential research collaborations, or lecture/meeting support (Round Tables, Congresses, Symposia, etc.); and to ensure a high level of scientific or educational integrity in these collaborative efforts. Develop awareness and understanding of competitor issues/intelligence - for example, product strategies, studies, commercial messages, positioning, etc - and communicate, where appropriate, within the Company. Continuous and consistent support to the Medical / Marketing teams in gathering Insights and feedbacks from HCPs and Patients for more impactful brand plans / New products Attend relevant Scientific Societies meetings and Conferences, and develop summaries of key messages for use within the Company - such as key areas of scientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeutic area, etc. Upon request, assist physicians to appropriately direct requests for access to Company products on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements. Support sales/marketing/internal team areas to develop their scientific and technical expertise through the delivery of scientific update presentations. Ensure up to date knowledge of products uses and external data. Provide key opinion leaders and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest. Support in Digital engagement of HCPs & patients through specific programmes as and when required Participate along with Medical Affairs & Clinical Operations team in real world data collection programmes TECHNICAL COMPETENCIES: Therapeutic Area Expertise Management Skills Communication Skills Compliance & Process Improvement Skills Problem/Conflict Solving Ability Priority Setting Relationship Building REQUIRED CORE COMPETENCIES / ATTRIBUTES: Adaptability: Maintain effectiveness when experiencing major changes in work tasks or the work environment; adjust effectively to work within new work structures, processes, requirements, or cultures. Consider change or new situations as opportunities for learning and growth. Persevere when encountering adversity. When confronted with a problem or crisis consider alternatives and then take timely action. Effectively prioritize work tasks. Initiative: Take prompt action to accomplish objectives; is proactive. Maintain a strong focus on internal and/or external customers. Continuously monitor relevant information, key issues and/or trends. Proactively seek feedback and adapts behavior to improve performance. Demonstrate a willingness to learn new aspects of the business. Display Ownership for end to end execution of initiatives. Innovation: Generate innovative solutions in work situations; try different and novel ways to deal with work problems and opportunities. Use best practice and benchmark data to increase organizational performance. Identify opportunities to improve efficiencies and reduce costs. Integrity: Firmly adhere to codes of conduct and ethical principles. Exhibit honesty. Present information accurately and completely. Keep commitments to work colleagues and customers. Acknowledge and respond constructively to failure and mistakes. Teamwork & Collaboration: Work effectively and cooperatively with others; establish and maintain good working relationships with internal and external partners to facilitate the accomplishment of work goals. Help others achieve shared goals. Demonstrate a willingness to listen without interrupting. Open to diverse and different ideas. Competencies ADAPTABILITY Responds to changes in the business and clinical practice within the country; considers the impact of these changes on the assigned product(s) and therapeutic area(s) and recommends ways to take advantage of new opportunities or counter threats to the business. INITIATIVE Develops awareness and understanding of competitor issues/intelligence and communicates this information, where appropriate, within the affiliate. Applies therapeutic area knowledge to recommend clinical studies and other medical projects that will strengthen the position of assigned product(s). INNOVATION Helps develop EPD strategy by identifying future opportunities for the assigned product(s) and therapeutic areas(s) and works with HQ, Area and Affiliate colleagues to take advantage of those opportunities. INTEGRITY Ensures that all activities and interactions are conducted in accordance with all applicable local, global and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice. TEAMWORK & COLLABORATION Supports sales/marketing/internal Affiliate teams to develop their scientific and technical expertise. Participates in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts. Technical Competencies THERAPEUTIC AREA EXPERTISE Maintains an up-to-date scientific knowledge of assigned product(s) uses and key external data. Provides scientific support for, and helps maintain professional and credible relationships with, key opinion leaders and academic centers to ensure access to current medical and scientific information on the assigned products and areas of therapeutic responsibility. Supports sales/marketing/internal Area teams to develop their scientific and technical expertise through the delivery of scientific update presentations, and periodic training as required. MANAGEMENT SKILLS Uses resources effectively and efficiently. Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects. Maintain and operate within budget. Capable of analyzing and investigating issues and problem solving. COMMUNICATION SKILLS Effectively practices listening skills before responding to issues. Effectively writes, presents and communicates information to internal and external clients, including divisional management. Effective negotiation skills. COMPLIANCE & PROCESS IMPROVEMENT SKILLS Demonstrates the ability to exercise good judgment on regulatory compliance issues. Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities. Able to insure compliance to regulations from direct reports and outside contractors (CRO). PROBLEM/CONFLICT SOLVING Able to analyze situations and conflicts without pre-judgments and assumptions Listens carefully and with an open mind Provides direct, complete, corrective and actionable feedback Reads situations quickly Settles disputes Negotiates common ground for win/win solutions PRIORITY SETTING Prioritizes activities and projects, in order to better spend own time and others for what would provide the optimum return to the organization. Quickly senses what will help or hinder accomplishing a goal Eliminates roadblocks Relationship Building Builds credible, meaningful & deep relationships with internal and external stakeholders Is sensitive towards unmet needs of internal and external customers KEY INTERFACES: EPD medical personnel: Clinical Research Managers, Clinical Operations Managers, Medical Advisors; Medical Information team / specialists; EPD Pharmacovigilance / drug safety personnel Marketing department across therapeutic area Sales organization of the geographic area of responsibility. Administrative personnel of the Medical Department and of the Business Unit. Healthcare personnel (including; physicians, nurses, pharmacists). Patients (through Patient Awareness Programs) Participating Research Investigators Key Opinion leaders Institutions and Scientific or Medical Societies International Medical Development / Global Project Team (GPT) personnel AUTHORITY AND REPORTING LINES: This position reports into the medical department- - Senior Manager RMA / Head RMA LOCATION: This function is field based. IDEAL CANDIDATE CRITERIA: Graduate or Post Graduate Medical Degree in Pharmacology (Preferable) or Allied Sciences Keen interest in developing and maintaining expert knowledge for assigned therapeutic area/product and in medical research in general. Knowledge of the scientific methods applied to clinical research and the current legislative/regulatory controls. Solid knowledge of the pharmaceutical environment and excellent skills to build stake-holders relationship. Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity. A good command over spoken and written English CAREER DEVELOPMENT: Possible career development roles: Manager-Medical Affairs or Medical Advisor Head of Affiliate Medical Area Medical Advisor EPD Strategic Medical Affairs Clinical Development, GPRD, I & D Product Management JOB FAMILY: Medical & Scientific Affairs LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Description Medical Scientist Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan) Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans, Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews, Authors medical data queries and reviews query responses, approves query closure in association with Medical Director, May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed, Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed, Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review, Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner, Attends at Trusted Process meetings and may participate in internal and external audits, Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology, Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans Adheres to customer policies and standard operating procedures, as required in project plans, Qualifications Degree in life sciences (MSc, PharmD, PhD, DMD, MD) or equivalent with relevant scientific experience and/or training discipline, Excellent time management skills to handle multiple tasks and meet deadlines while delivering high quality work in a highly regulated and dynamic environment is essential, A self-starter and comfortable with fluctuating timelines, work demands and changes in scope of work, Ability to troubleshoot situations as needed and understands when issues or questions need to be escalated to the leadership, Understanding of scientific principles to assure effective and high-quality medical data analysis, Excellent written and oral communication skills, Excellent computer skills: MS Office programs, spread sheets, presentations, Prefer knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines, Strong team player with excellent interpersonal skills and ability to work effective in a cross-functional team environment, Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

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

Bhosale Micropath Laboratory is looking for Dip. Physician Asstt. to join our dynamic team and embark on a rewarding career journey Collaborate with physicians and other healthcare professionals to provide comprehensive patient care Conduct patient assessments, including medical history reviews, physical examinations, and diagnostic tests Diagnose and treat acute and chronic medical conditions under the supervision of a licensed physician Develop and implement patient care plans, including prescribing medications, ordering and interpreting laboratory tests, and providing patient education Perform procedures and assist in surgeries, as appropriate to the specialty and setting Monitor and evaluate patient progress, adjusting treatment plans as necessary Document patient encounters, including medical histories, treatment plans, and progress notes, in electronic medical records (EMRs) Communicate with patients and their families regarding diagnoses, treatment options, and follow-up care Collaborate with interdisciplinary teams to coordinate patient care and ensure continuity of care Stay updated with current medical literature and best practices in healthcare Adhere to legal and ethical standards, including maintaining patient confidentiality and following professional codes of conduct Participate in quality improvement initiatives and contribute to the development of clinical protocols and guidelines Assist in training and mentoring other healthcare professionals, such as medical students or nurses, as appropriate

ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, We are currently seeking a Pharmacovigilance Project Lead to join our diverse and dynamic team As a Pharmacovigilance Project Lead at ICON, you will oversee the strategic management of safety monitoring and reporting for clinical trials and post-marketing activities You will ensure compliance with regulatory requirements, lead pharmacovigilance projects, and drive initiatives to enhance patient safety and data integrity across all projects, What You Will Be Doing Leading and managing pharmacovigilance projects, including overseeing safety data collection, evaluation, and reporting processes, Developing and implementing strategies to ensure the effective management of adverse event reports and compliance with global regulatory standards, Coordinating with cross-functional teams, including clinical operations, regulatory affairs, and data management, to support project objectives and resolve safety-related issues, Ensuring the timely preparation and submission of safety reports, including periodic safety updates and risk assessments, to regulatory authorities and sponsors, Providing leadership and guidance to pharmacovigilance teams, including training and mentoring staff to support project success and compliance, Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree or certification in pharmacovigilance is a plus, Proven experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting and regulatory requirements, Strong leadership and project management skills, with experience overseeing complex pharmacovigilance projects and managing cross-functional teams, Excellent analytical and problem-solving abilities, with a track record of driving improvements in safety monitoring processes, Effective communication and interpersonal skills, with the ability to collaborate with diverse stakeholders and manage multiple priorities in a fast-paced environment, What ICON Can Offer You Our success depends on the quality of our people Thats why weve 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 familys 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 familys 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 Were 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 requirementsWe would encourage you to apply regardless theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles, Are you a current ICON EmployeePlease click here to apply

As part of a global team, you will be the second level contact to support our commercial organizations/customer facing functions with quality & regulatory knowledge for our global Life Science product portfolio. You will assist and advise our customers on quality and regulatory topics such as but not limited to providing consultative services and documentation support. You will interact with various internal functions (e.g. Quality, Regulatory, Business) to come up with resolution to address our customers Quality (Q) & Regulatory (R) related inquiries. Being the interface between customers and our internal functions, you will give advice to our customers as well as our internal stakeholders, explain complex topics including to non-experts and support the development of market leading solutions. Create/Continue to improve our digital solutions and workflows with aim to achieve better customer satisfaction. As a Subject Matter Expert for a specific group of product portfolio and/or Quality/Regulatory topic, you will drive the continuous improvements and implementation of digital workflows to improve our service level support. Who You Are: Masters Degree in Life Sciences, Chemistry, Biology, or equivalent. Minimum 4 years professional working experience in a customer service-oriented environment in Life Science, Biotechnology, or related industry. Good understanding of quality & regulatory guidelines is a plus especially for pharmaceutical raw materials (e.g. Excipient & API). Digital savvy in using digital tools are necessary and important in daily work. Proficiency in using relevant software applications such as SFDC, SAP & Microsoft 365. Act as a voice of our customers by advocating the importance to support when necessary and work with relevant stakeholders to find feasible solutions to resolve challenges faced. Global mindset and willing to attend global calls outside office hours (e.g. night calls). APAC regional exposure experience will be an added advantage.

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work Job Description: • Act as SME for safety business and track industry trends relevant to safety • Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions • Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities • Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry • Build partnership with senior leadership across the industry in Safety and PV • Represent the company in trade conferences, speaker sessions etc. • Identify and build potentially synergistic partnerships to expand client and service footprints • Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed - MBBS/ MD with a minimum of 14-18years of experience in drug safety or a related field; Master/Diploma in Management degree is added advantage - Experience in the pharmaceutical industry, preferably in drug safety, pharmacovigilance, or clinical development - Knowledge of pharmacology, toxicology, and clinical trial methodology - Understanding of FDA and international regulatory requirements related to drug safety and pharmacovigilance - Strong analytical and problem-solving skills - Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams - Demonstrated ability to prioritize tasks and manage multiple projects simultaneously - Proficiency in data analysis tools (e.g., Excel, SAS) and safety databases (e.g., Argus, ARISg) - Good communication skils and relationship building skills - Act as SME for safety business and track industry trends relevant to safety - Work in collaboration with the Sales and the Solutioning teams to improve win ratio and opportunity conversions - Responsible for improving capability presentations and Identifying service areas and solutions and work with the operational leadership to build capabilities - Participates in the analysis and definition of efficient, cost effective and creative solutions deliver competitive value propositions to the industry - Build partnership with senior leadership across the industry in Safety and PV - Represent the company in trade conferences, speaker sessions etc. - Identify and build potentially synergistic partnerships to expand client and service footprints - Be part of safety consulting engagements as well as provide oversight and expertise on operations as needed Show more Show less

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities 1 . Conduct in-person and virtual training sessions, workshops, and seminars on clinical research processes, GCP, ethical guidelines, safety reporting, and trial protocols. 2 Create and maintain curriculum, training materials, and e-learning content for clinical research personnel. 3 Conducting sessions on clinical research, clinical data management, pharmacovigilance, medical Coding. Qualifications B.Pharm, M. pharm, pharm D, Any Life Science Graduate. Show more Show less