1738 Pharmacovigilance Jobs - Page 24

Experience: 2-3 years Key Responsibilities: Review and interpret physician orders and prescriptions for accuracy. Counsel patients on proper use, dosage, and side effects of medications. Monitor patient responses to medications and adjust treatment plans accordingly. Collaborate with doctors, nurses, and other healthcare professionals to ensure optimal patient outcomes. Maintain accurate records of prescriptions and inventory. Participate in ward rounds and clinical discussions. Ensure compliance with all regulatory and safety standards. Educate healthcare staff on drug updates and protocols. Assist in pharmacovigilance and report adverse drug reactions. Support antimicrobial stewardship programs. revive plus hospital hyd moti nagar hyd 500072 phone no:-8317535714 thank you... Job Type: Full-time Pay: ₹25,000.00 - ₹30,000.00 per month Benefits: Commuter assistance Schedule: Day shift Work Location: In person

Job Description Preparation and Maintenance of Pharmacovigilance System Master file (PSMF) for Global, and other regional markets as applicable, including preparation of detailed description of Pharmacovigilance System (DDPS), summary of PV systems etc. Management of PV system master file(s) and regular updates of associated annexures for PV system Manage PV matters for subsidiaries and affiliates across the globe including but not limited to integration of pharmacovigilance and drug safety between DSRM and subsidiaries, development and formation of SOPs and procedures. Perform KPI monitoring and compliance monitoring activities for subsidiaries and other countries where Lupin does not have subsidiary but operates through local partners. Ensure Pharmacovigilance due diligence in matters of mergers and acquisitions. Coordination with vendors, internal and external stakeholders relevant for various DSRM functions Actively contribute to the development of processes, applications and methodologies in the department including continuous process improvement Education Post Graduation in Pharmacy or Pharmacy Work Experience Experienced candidate with 8 plus years of experience in relevant sphere of work which is subsidiary and affiliate management, along with experience of handling diverse PV system master files and global awareness on PV requirements across the globe. Competencies Result Orientation Customer Centricity Stakeholder Management Innovation & Creativity Developing Talent Process Excellence Collaboration Strategic Agility

Manager - DSRM (Aggregate and SDEA) 1. Managing the Safety Data Exchange Agreement mailbox, to track the emails received and ensure appropriate action is taken. 2. To ensure appropriate agreements are in place with prospective and existing business partners and ensure timely execution and renewal of agreements 3. To liaise with cross functional teams to seek additional information 4. To ensure compliance to the agreements and be audit / inspection ready. 5.Preparing and maintaining the aggregate report writing plan to plan and keep a track of the global aggregate report submissions 6. Preparing and maintaining the aggregate report compliance tracker and ensuring compliance and appropriate corrective and preventive actions 7. Maintenance and regular update of global / regional risk management measures tracker 8. Ensuring the implementation of additional risk minimization measures (aRMMs) and timely evaluation of the effectiveness check of additional risk minimization measures for Lupin products globally 9. To liaise with cross functional teams like regulatory affairs, marketing, local affiliates in ensuring appropriate implementation of the risk management plan. Competencies Developing Talent Result Orientation Customer Centricity Strategic Agility Process Excellence Innovation & Creativity Stakeholder Management Collaboration B. Phram / M. Pharm Graduation Masters in Pharmacy 7-8 years of experience in Aggregate Reports, Buiseness partner agreements 7-8 years of experience in Aggregate Reports, Risk Management Plans and Business partner agreements.

Long Description 1 Responsible for lifecycle management of DSRM procedural documents in EDMS and non-procedural documents within due date which includes document creation, document revision, making document obsolete, making document effective, releasing document, sharepoint update and communication to relevant stakeholders 2 Responsible as SOP coordinator to perform roles as Author in edit step and QA authorisation in Release approval step 3 Responsible to perform role of Training Coordinator in Training step within EDMS as required 4 Oversight and management of compliance of DSRM training requirements and activities in LMS 4 Support and oversight of subsidiary Global PV training status as applicable 5 Oversight and management of Annual Basic PV compliance for India 6 Oversight on team's task completion, annexures, sharepoint updates and people management. 9 Creation of status presentations and other adhoc presentations as required 7 People Management Competencies Strategic Agility Innovation & Creativity Process Excellence Customer Centricity Collaboration Stakeholder Management Developing Talent Result Orientation Education- Life Science Post Graduate, MPharm, BPharm, Work Experience Experience in Pharmacovigilance operations, Quality Management System, Training, Use of Systems for SOPs and Training Management

Job Title: Training & Placement -AGM / Senior Manager No. of Opening : 1 Location: Delhi Department: Training & Placement / Corporate Outreach Domains Covered: IT, Pharma, Management, Media Reports To: Head – Corporate Outreach / Head – Training & Placements Role Objective: To facilitate and manage the end-to-end campus recruitment, internship, and training processes for assigned academic domains at the respective campus, while nurturing strong industry connections and ensuring high employability of students through skill development and corporate exposure. Eligibility Criteria • Postgraduate degree in HR, Business, Education, or domain-specific field (IT, Pharma, Media) • Minimum 5–10 years’ experience in placements domain and region • Tech-savvy: MS Excel, placement ERP, LinkedIn, Google Workspace • Regional language knowledge (as applicable: Hindi/Marathi/Kannada) Desirable Attributes • Existing contacts with companies in domain-specific sectors • Experience in organizing or participating in campus recruitment/industry conclaves • Ability to travel locally • Data-driven mindset and report-oriented working style Key Responsibilities (Common Across Locations & Domains) Industry Engagement & Relationship Management Placement Drive Planning & Execution Internship & PPO Facilitation Alumni Coordination Initiate discussions with companies for long-term collaboration via CoEs and MoUs Key Performance Indicators (KPIs) • Placement Rate: % students placed per domain/program • Recruiter Engagement: No. of new & repeat recruiters engaged domain-wise • Internship to PPO Rate: % students offered PPOs post internship • Training Completion Rate: % students completing all required CLC/prep sessions • Feedback & Satisfaction: Recruiter feedback score, student satisfaction post-drive • Alumni Interaction: No. of alumni engagements/events organized per semester Domain-Specific Responsibilities A. IT & Computer Science Domain • Build partnerships with IT services, product companies, SaaS startups, cybersecurity firms, and MNCs • Organize coding bootcamps, GitHub/portfolio workshops, and technical test prep • Facilitate hackathons, algorithm contests, and DevOps/AI/ML project showcases • Track students' technical certifications (AWS, Azure, GCP, Python, etc.) B. Pharmaceutical Sciences Domain • Engage with pharma companies, CROs, healthcare analytics firms, hospitals, and biotech startups • Coordinate training on regulatory affairs, pharmacovigilance, QA/QC, clinical trials • Support lab-to-corporate transitions with exposure to industry GMP standards • Help students participate in pharma expos, biotech summits, and poster presentations C. MBA / Management Domain • Collaborate with BFSI, consulting, FMCG, EdTech, and e-commerce firms • Coordinate case-solving workshops, management simulations, and group discussions • Plan company-specific training for marketing, finance, HR, analytics roles • Facilitate summer internships with structured feedback and project evaluation D. Media & Communication Domain • Connect with media houses, advertising agencies, OTT platforms, and PR firms • Organize industry guest sessions on content creation, scriptwriting, branding, and digital media trends • Support student portfolios for creative, design, and production roles • Host industry-led workshops on video editing, journalism ethics, and campaign design

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role : Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who you are: Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

Looking for 1 plus years experienced Pharmacovigilance professional with current experience in data base experience argus or arisg or any safety data base and should be trained students complete case processing It is immediate position, interested one can send resume to +91 9019973004 Job Type: Part-time Pay: ₹5,000.00 - ₹6,000.00 per month Education: Bachelor's (Preferred) Experience: total work: 1 year (Preferred) Expected Start Date: 07/07/2025

Senior Biostatistician (9-18 yrs exp, PhD/Postgrad in Stats)to lead clinical trial design, statistical analysis, and TLG development. Responsibilities include protocol development, ADaM specs review, statistical QC, and ensuring regulatory compliance Required Candidate profile Must collaborate with cross-functional teams, support submissions, and drive innovative methodologies. Exp in SAS/R, clinical reporting, and adaptive designs preferred. (20-24 LPA, PAN India).

Job Title: Associate Director, Patient Safety Scientist Global Career Level: E Introduction To Role The Associate Director, Patient Safety Scientist role works collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to review safety data and related documents for potential safety issues. This role involves authoring and providing pharmacovigilance input to safety documents and regulatory reports. The Associate Director also leads meetings and presents safety data and analyses. Accountabilities Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate. Represents Patient Safety on cross-functional project teams for marketed products and/or developmental compounds. Presents safety information at external meetings. Performs duties as a Safety Strategy and Management Team (SSaMT) leader. Presents issues to the Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP, and other key stakeholders. Produces accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. Collaborates with GSP and Clinical representatives to author the Reference Safety Information (RSI) for assigned marketed products and/or development products; coordinates meetings and tracks timelines to ensure completion. Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to establish the safety profile of drugs and manage the risk to patients. Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Contributes to the Patient Safety component of contracts/agreements with third parties to ensure quality and integrity of agreement. Trains junior members of the team in Patient Safety tools and systems. Authors/provides strategic input to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. Essential Skills/Experience Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development Comprehensive understanding of applicable Patient Safety regulatory obligations Awareness of Patient Safety policies, processes, and procedures Awareness of medico-legal aspects of patient safety 9 to 11 years of Patient Safety experience Total of 12 to 14 years of experience Communication Well-developed interpersonal skills Cultural sensitivity Ability to network with other functions globally Impact On Business Results Quality and timeliness of work through surveillance and case handling activity Provision of timely information, meeting deadlines for compliance with regulatory reporting requirements for periodic reports, safety due diligence of products, and contributing to correct labeling through safety surveillance activities Maintenance of efficient and effective processes, with a focus on productivity Internal And External Contacts/Customers Patient Safety personnel at all levels Regulatory Affairs and other AstraZeneca personnel Leadership Skills Passion for Customers: Engages in collaboration with customers by directly interacting with them to ensure delivery of a complete solution. Thinks Strategically: Applies a broad perspective by using knowledge and experience to challenge and adapt current approaches/ways of doing things. Acts Decisively: Makes effective decisions under pressure in the absence of complete information and seeks support when needed. Drives Performance: Holds immediate team accountable to quality standards by clarifying the objectives and timelines for deliverables. Works Collaboratively: Integrates diverse views by seeking input and incorporating cross-functional views into decisions/proposals. Develops People and Organisation: Provides support and feedback to junior staff while continuing to develop him/herself. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we follow the science and pioneer new frontiers. Join our team dedicated to Oncology with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver 6 new molecular entities by 2025. Our courage, curiosity, and collaboration drive us to make bold decisions driven by patient outcomes. Empowered to lead at every level, we are free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Pioneers of collaborative research, we have built an unrivalled scientific community both internally and externally. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers. Join us to build a rewarding and meaningful career as part of a team committed to improving the lives of millions with cancer. Ready to make a difference? Apply now! Date Posted 04-Jul-2025 Closing Date 08-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Vizen Lifesciences is seeking a dedicated Medical Information Call Center (MICC) Team Lead, ,Quality Reviewer, and Associates to join our team. The ideal candidate should have an educational background in B.Pharm, M.Pharm, or Nursing , with 0 to 15 years of relevant experience in a MICC environment. This role requires excellent English language skills , proficiency in understanding the US accent , and the flexibility to work in 2pm to 10 PM shift Key Responsibilities: Handle inbound and outbound calls, document them, and perform follow-up calls as per client requirements and SOPs. Ensure compliance with Vizen Lifesciences and client quality requirements. Send completed documents for QC in hourly reports. Follow telephone etiquette in the MICC process. Refer to safety reference and client-provided documents while handling calls. Manage test calls, faxes, voicemails, and emails. Categorize call information into product complaints, AE/SAE, medical queries, and product quality complaints. Forward AE/SAE information to the pharmacovigilance department and product complaints to the QA department as required. Contact manufacturing units or clients regarding medical inquiries with unavailable information. Adhere to administrative, technical, and physical safeguards to protect all data, ensuring confidentiality, integrity, and availability. Handle respective trackers and perform reconciliation. Ensure adherence to client-specific SOPs for all activities. Attend training and client meetings as needed. Provide feedback and training to team members. Archive pharmacovigilance documents. Education Qualifications requirement: Bachelors or Masters degree in Pharmacy or Nursing. Experience required: 0 to 15 years of relevant experience in Medical Information Call Center (MICC) Team Leads and ,Quality Reviewer positions require additional leadership or quality review experience Mandatory Requirement: Excellent English language speaking and writing skills.

As a Therapy Business Manager you will be responsible for the development and performance of all sales strategies in assigned market. Further you will drive primary sales, secondary sales and ensuring brand presence in defined markets. You will supervise/manage the distributor network to achieve desired sales objectives thereby ensuring achievement of financial and ethical objectives of the division as per the business strategy. To achieve this you will have authority to develop your customer management plan, approve expiry products issue credit note for distributors under your control, recommending appointment and credit limits of distributors, develop, execute & plan your resource utilization and participate in Strategy Execution review meetings to ensure alignment. You have a very important role to play in Divisions success. Roles and Responsibilities in detail Territory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors /chemist (Trade) as per the therapy /product requirement and maintain the same in physical/electronic format. Business generation & development: Achieve monthly, quarterly, half-yearly, and yearly Sales targets by promoting companies products ethically to customers as per the business plan Having science base discussions with doctor and chemist for promotion of the product in the clinic and at the chemist place Organizing Camps (CME) as per the division strategy and customers need Execute the customer management plan to ensure that all the customers are covered as per the plan. Lead and execute strict adherence to Abbott Code of Business conduct Set examples on implementation of the code of business conduct, RCPA, Pharmacovigilance to ensure compliance Demonstrate and promote professional behavior in line with Abbott Values of Pioneering, Achieving, Caring, and Enduring Ensure a high level of customer service and manage any difficult customer situations. Division and business strategy will be shared with you on time to time base which you will have to execute to the fullest To attend and participate in Strategy meetings, briefing sessions, doctors meets, workshops, training programs, and any other programs undertaken by the company to equip you or activities for the performance of your job or promote the sales of products of the company or to improve company image. Meet minimum KPIs as follows: 100% coverage of Doctors. Customer Call average as per the customer management plan of the division /therapy. Market intelligence collection, retailer level inventory management calls as per the product profile and marketing strategy of the therapy /division. Experience/Training Required 2+ Years of experience. Candidate with prior/current experience in the same therapy. Candidates from MNC and top Indian Pharma companies will have added advantages. Fluent and confident in communication. LOCATION: India > Chennai : 147 Greams Road t

Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision. Essential Functions Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate; Competently writes regulatory and/or technical documents with minimal review by senior staff; Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues; Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate; May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff; May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate. May be involved in a Regulatory and/or IQVIA Initiative; Performs other tasks or assignments, as delegated by Regulatory management; May manage meetings with Regulatory Agencies; May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations; May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative; Performs other duties, as business needs require; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline At least 8 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner; Expert in planning and delivering work on time keeping quality parameter in mind; Knowledge of regulatory procedures in appropriate region particularly marketing authorization transfers and relevant cross-functional dependencies; Good working knowledge of regional regulatory intelligence; Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable; Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for MATs, Publishing projects; Project leadership experience; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

Location Bengaluru, Karnataka, India Job ID R-226571 Date posted 03/07/2025 Job Title: Associate Director, Patient Safety Scientist Global Career Level: E Introduction to role: The Associate Director, Patient Safety Scientist role works collaboratively with the Global Safety Physician (GSP) and Senior Patient Safety Scientist to review safety data and related documents for potential safety issues. This role involves authoring and providing pharmacovigilance input to safety documents and regulatory reports. The Associate Director also leads meetings and presents safety data and analyses. Accountabilities: Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate. Represents Patient Safety on cross-functional project teams for marketed products and/or developmental compounds. Presents safety information at external meetings. Performs duties as a Safety Strategy and Management Team (SSaMT) leader. Presents issues to the Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP, and other key stakeholders. Produces accurate and fit-for-purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. Collaborates with GSP and Clinical representatives to author the Reference Safety Information (RSI) for assigned marketed products and/or development products; coordinates meetings and tracks timelines to ensure completion. Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to establish the safety profile of drugs and manage the risk to patients. Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Contributes to the Patient Safety component of contracts/agreements with third parties to ensure quality and integrity of agreement. Trains junior members of the team in Patient Safety tools and systems. Authors/provides strategic input to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. Essential Skills/Experience: Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development Comprehensive understanding of applicable Patient Safety regulatory obligations Awareness of Patient Safety policies, processes, and procedures Awareness of medico-legal aspects of patient safety 9 to 11 years of Patient Safety experience Total of 12 to 14 years of experience Communication: Well-developed interpersonal skills Cultural sensitivity Ability to network with other functions globally Impact on Business Results: Quality and timeliness of work through surveillance and case handling activity Provision of timely information, meeting deadlines for compliance with regulatory reporting requirements for periodic reports, safety due diligence of products, and contributing to correct labeling through safety surveillance activities Maintenance of efficient and effective processes, with a focus on productivity Internal and External Contacts/Customers: Patient Safety personnel at all levels Regulatory Affairs and other AstraZeneca personnel Leadership Skills: Passion for Customers: Engages in collaboration with customers by directly interacting with them to ensure delivery of a complete solution. Thinks Strategically: Applies a broad perspective by using knowledge and experience to challenge and adapt current approaches/ways of doing things. Acts Decisively: Makes effective decisions under pressure in the absence of complete information and seeks support when needed. Drives Performance: Holds immediate team accountable to quality standards by clarifying the objectives and timelines for deliverables. Works Collaboratively: Integrates diverse views by seeking input and incorporating cross-functional views into decisions/proposals. Develops People and Organisation: Provides support and feedback to junior staff while continuing to develop him/herself. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, we follow the science and pioneer new frontiers. Join our team dedicated to Oncology with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver 6 new molecular entities by 2025. Our courage, curiosity, and collaboration drive us to make bold decisions driven by patient outcomes. Empowered to lead at every level, we are free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Pioneers of collaborative research, we have built an unrivalled scientific community both internally and externally. Working seamlessly and inclusively, together we expedite research in some of the hardest-to-treat cancers. Join us to build a rewarding and meaningful career as part of a team committed to improving the lives of millions with cancer. Ready to make a difference? Apply now! Date Posted 04-Jul-2025 Closing Date 08-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Company Description Neoplus Translation, established in 2012, specializes in localizing messages to resonate in new languages. Our in-house translators cover over 140 languages including European, Middle East, Asian, and African languages. Neocubes Pharma, a subsidiary of Neoplus Translation, provides tailored Regulatory and Pharmacovigilance services to meet client requirements globally. We offer comprehensive safety monitoring and regulatory services, adhering to international standards and regulations. Our company is ISO 9001:15001 certified with a network of qualified auditors across the globe. Role Description This is a full-time, on-site role located in Ahmedabad for an Artwork QC Documentation-Fresher. The role involves day-to-day tasks such as quality checking artwork files, ensuring accuracy of documentation, coordinating with teams for revisions, and maintaining records of documentation. The candidate will also be responsible for adhering to regulatory standards and internal policies. Qualifications Accuracy and attention to detail in quality checking and documentation Proficiency in coordinating with multiple teams and managing documentation records Understanding of regulatory standards and compliance requirements Strong organizational and time-management skills Ability to work independently and on-site in Ahmedabad Bachelor's degree in a relevant field is preferred

Key Responsibilities Conduct in-person and virtual training sessions, workshops, and seminars on clinical research processes, GCP, ethical guidelines, safety reporting, and trial protocols. Create and maintain curriculum, training materials, and e-learning content for clinical research personnel. Conduct sessions on clinical research, clinical data management, pharmacovigilance, and medical coding. About Company: Fusion Technology Solutions is one of the best skill development training institutes, offering a wide range of courses under one roof. We provide training across various industry sectors, including healthcare/medical with clinical research, medical coding, and pharmacovigilance courses; aviation, offering cabin crew and ground staff courses; IT, featuring PHP, JAVA, Stack Development courses, and more; research, including market research and data science courses; and marketing, with a comprehensive digital marketing course.

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us Your Role Generate or convert doctors for our product portfolio. Secondary sales – Ensuring to achieve secondary sales targets through prescription generation by each of his BE. Good at relationship with KOLs (Top Physicians, Endocrinologists & Cardiologists) Day to day sales reporting Effective query handling and customer queries. Ensuring 100% Implementation of Company’s strategies Pharmacovigilance (Adverse Event Reporting) – To collect adverse drugs reaction (ADR) incidences including lack of efficacy related to medicinal products up to the maximum possible level of completeness and forward to local Patient Safety team immediately within 24 hours of ADR awareness. The additional information can be submitted as soon as possible Who You Are Any graduate Freshers or minimum of 1-2 years of experience in any pharma company Should have strong product knowledge & communication skills What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team!

SANOFI HEALTHCARE INDIA PRIVATE LIMITED is looking for Associate Scientific Writer to join our dynamic team and embark on a rewarding career journey Develop and write scientific manuscripts, reports, and presentations for various audiences. Conduct literature reviews and synthesize research findings to support scientific writing. Collaborate with researchers, clinicians, and other stakeholders to gather and verify information. Ensure the accuracy, clarity, and compliance of scientific content with industry standards and regulations. Manage multiple writing projects simultaneously, ensuring timely delivery. Stay updated with the latest advancements in scientific writing and research methodologies.

Summary -The Group Lead, Medical Safety Operations (MSO), is responsible for managing a group of Medical Safety Experts (MSE) and Senior Medical Safety Experts (Sr MSE) within MSO. This is accomplished by organizing and planning of the deliverables of the Team. He/she may keep an oversight of all outsourced activity for Medical Safety function. Acts as point of contact for global Medical Safety for the External Service Providers (ESPs) performing outsourced activities. Leads and supports projects that are within the scope of medical safety operations. The Group Lead is also responsible for the development and implementation of: Enhanced medical safety quality processes and procedures. Enhanced line function excellence and standards. About the Role Major accountabilities: Manage a group of MSE & Sr MSE within the MSA&EE. Ensure that their deliverables are met according to the agreed standards and timelines. Ensure and drive compliance & quality of deliverables to consistently high standards. Participate in the MSA&EE management strategy and operational plan. Ensures optimal communication and feedback between the Therapeutic Areas and the Medical Safety Experts. Support the Head of Med Safety Assessment & ESP Engagement in soliciting and forecasting future requirements for the MSA&EE. Participate in organizing and planning the work of the MSE & Sr MSE as per Therapeutic area aggregate reports and other documents schedule and ad-hoc urgent activities i. e. Health Authority Requests. Liaise with the Head Patients Safety and Global Program Safety Leads to get feedback on the performance of the MSE & Sr MSE and ensure that adequate training is put in place accordingly. Is responsible for overall training and career development planning for the team MSO. Develops effective relationships with internal and external stakeholders to ensure successful outcomes of objectives. Participate in analyzing the workload of the Team based on a detailed Work-Unit assessment. Liaise, support, and represent the MSA&EE during Audits and Inspections undertaken at PS&PV. Cross functionally collaborates with other work teams of PS&PV and represent MSA&EE in common forums. Contribute to the MSA&EE resource planning. Build a high performing group of MSE & Sr MSE and recruit, retain and develop best talent; assess resource needs on a regular basis to achieve ongoing process improvements, to provide sufficient process excellence support and to create/maintain a sustainable compliance culture. Keeps an oversight of all applicable outsourced activities related to medical function. Acts as point of contact for global Medical Safety for questions related to outsourced activity. Supports quality and compliance lead to ensure quality and compliance of all outsourced activities. Ensure transparent and clear communications with ESPs. Participate in applicable ESP governance meetings. Collaborate with the ESPs and provide trainings as necessary. Support onboarding and training activities within Medical Safety. Ensures completion of all MRQC arbitrations in timely manner from ESPs. Ensure timely completion of scores for OSCM related to medical function. Work in close collaboration with Head of Med Safety Assessment & ESP Engagement for early identification of issues related to ESPs. Represents Medical Safety in cross-functional and/or cross-departmental initiatives which aim to improve processes and ensure a quality and compliance focused environment either by direct involvement or by ensuring appropriate Line Function representation. Collaborates with PS&PV QA and Global Development Clinical Quality and supports the implementation of the Pharmacovigilance Quality Plan. Tracks, reports and follows-up to completion all Corrective Actions and Preventative Actions (CAPA) identified during audits and inspections. Identifies, manages and reports on Medical Safety Key Quality Indicators. Recommends corrective actions and ensures all relevant follow-up activities are completed based upon report outputs. Ensures compliance to and supports adequate training opportunities for new SOPs and Business Guidance. In collaboration with LF and QA, ensures individuals comply with Novartis PV processes. Tracks deviations from SOPs in Novartis QMS and in collaboration with QPPV office and PV compliance department, ensures appropriate documentation is filed and corrective actions are taken. Provides backup support for the Head of Med Safety Assessment & ESP Engagement. Key Performance Indicators (indicate how performance for this role will be measured) Efficiency of MSA&EE Team management and support underlined by delivery of high-quality activities/tasks to the therapeutic areas. Quality of the liaison between the MSA&EE and the Therapeutic Areas for work planning organization. Timeliness, quality, and efficiency of the results obtained through targeted training for the Team, Efficient strategy of the activity/task planning for the MSA&EE under responsibility in the Therapeutic Areas. Recruitment, retention and development of talents in the MSA&EE. Finalization of all scores related to medical function (ICSR and PSUR) well within timelines. Health Authority Inspections and internal audits have no critical findings related to the Medical Safety function accountabilities in particular for quality and regulatory compliance due to medical function. Successful implementation of improvements as measured by sustainable changes and improved efficiency. Creative & innovative thinking for operational excellence, best practices and lessons learned. Job Dimensions (Indicate key facts and figures) Number of associates: Up to 15 associates (direct reports) Financial responsibility: (Budget, Cost, Sales, etc. ) Participation to the medical Safety operations resource planning. Impact on the organization: Scheduling and management of the Medical Safety Operations work in the different MSO circles. Cooperation between the Medical Safety operations and the medical function for work planning organization and efficiency of deliverables. Ideal Background: Education: Advanced degree or equivalent education/degree in life science/healthcare. MD, MBBS, PharmD, PhD preferred. Language: Fluent in spoken and written English. Experience : Required professional experience: 8 years in drug development in a major pharmaceutical company (of which 3 are in a global position in safety/clinical/medical affairs or other relevant line function at an operational or medical position) Demonstrated people management experience (direct/matrix). Strong leadership and people management skills, with ability to successfully lead, engage and develop a highly effective team. Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure. Quality oriented. Good planning, organizational and computer skills. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Job Overview Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision. Essential Functions Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate; Competently writes regulatory and/or technical documents with minimal review by senior staff; Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues; Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate; May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development; May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff; May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate. May be involved in a Regulatory and/or IQVIA Initiative; Performs other tasks or assignments, as delegated by Regulatory management; May manage meetings with Regulatory Agencies; May be assigned as Reviewer and/or Approver for Regulatory standard operating porcedures or cross-functional standard operating porcedures owned by other operations; May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative; Performs other duties, as business needs require; Qualifications Bachelors Degree Degree in Lifescience or related discipline Req Or Masters Degree Degree in Lifescience or related discipline At least 8 years relevant experience Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate; Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner; Expert in planning and delivering work on time keeping quality parameter in mind; Knowledge of regulatory procedures in appropriate region - particularly marketing authorization transfers and relevant cross-functional dependencies; Good working knowledge of regional regulatory intelligence; Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable; Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization; Ability to establish and maintain effective working relationships with coworkers, managers and clients; Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable; Ability to work on several projects, with direction from senior staff as appropriate; Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements; Ability to make decisions on discrete tasks under senior supervision; Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education; Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for MATs, Publishing projects; Project leadership experience; Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area; Problems faced are general and may require understanding of broader set of issues, but typically are not complex; Ability to adapt quickly to a rapidly changing environment; Applicable certifications and licenses as required by country, state, and/or other regulatory bodies . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

🚨 Calling #ExperiencedProfessionals in #Pharmacovigilance! 🚨 SHRM Biotechnologies Pvt. Ltd. is on the lookout for industry-academia experts in Pharmacovigilance to be a part of our specially designed job-oriented training programs. 📍 Role Type: Part Time - Hybrid, Contractual (Global applicants welcome) 🕒 Session Timings: Weekends or Evening Shifts If you have hands-on experience in industry and/ or academia and are passionate about sharing knowledge with future professionals, we’d love to connect with you! 📩 Apply by sending your resume to: 👉 careers@shrmbio.com 📩 CC: rupak@shrmbio.com 📞 For any queries, feel free to reach us at: 📱 +91-8013308122 | +91-8981003215 Let’s shape the future of pharmacovigilance together!

Medical Reviewer-Drug Safety Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title : Medical Reviewer Location : Mysore-Hybrid Function : Drug Safety Services ESSENTIAL DUTIES AND RESPONSIBILITIES: Oversee overall Pharmacovigilance (PV) and risk management activities. Review all appropriate data for product specific reports. Provide draft and review (carried out by separate individuals) all single/aggregate/cumulative medical assessments/benefit risk assessments for safety reports. Provide medical oversight white creating draft reports based on the approved SOP/WI process. Coordinate internal review process and finalize draft reports from medical point of view. Assist medical writer in addressing all comments from client and finalize. Should review the finalized report even if participated in assisting medical writer. Provide expert guidance in PV and Aggregate reporting areas. Coordinate all post marketing regulatory reporting and PV activities for assigned products to be carried out by Sitero aggregate reporting team. Preparation of sections of medical significance/inputs for aggregate safety reports such as PSUR, PBRER, Periodic Adverse Drug Experience Report (PADER), Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR. Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports. Prepare and review responses to adhoc regulatory queries. Appropriate scientific interpretation of relevant information for inclusion into drug safety documents, prepare and write analytical aggregate reports and other drug safety medical documents. Creating all documents in accordance with applicable Standard Operating Procedure (SOPs), conventions, and regulatory requirements. Planning, organizing, and managing daily work to meet service level timelines and deliverables. EDUCATION AND EXPERIENCE REQUIRED: 1-3 years experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable. Medical Degree (MBBS or higher) from recognized medical school. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Permanent, Full Time COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed. Willing to work in shifts as and when needed. DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Hiring: Team Lead Clinical Trials | Work from Office | Pune Location: Kothrud, Pune Shift: Evening / Night Job Type: Full-time (Work from Office) Salary: As per experience and best in industry Job Description: We are hiring for the position of Team Lead Clinical Trials . The role involves end-to-end management of clinical trial operations with a strong focus on quality, compliance, and timelines. The ideal candidate will lead cross-functional teams, manage client communication, and ensure the smooth execution of projects. Key Responsibilities: Lead teams including operations managers, team leads, quality analysts, and support staff. Monitor workflow and performance to identify and resolve issues. Provide mentorship and support to team members to promote a high-performance culture. Manage client onboarding, workflow planning, and quality assurance. Ensure compliance with industry regulations and client expectations. Present operational updates to senior management. Act as the primary contact for client communication and relationship management. Required Qualifications: Bachelors degree in Pharmacy or Life Sciences. 5 to 8+ years of experience in clinical research (BPO/KPO environment). At least 2 to 4+ years of experience in a leadership or team management role. Strong verbal and written communication skills. Excellent organizational and multitasking abilities. Work Environment: This is a Work from Office role based in Pune. Benefits: Competitive salary package. Health insurance and paid time off. Professional growth and learning opportunities. Only Walk-In Interviews Interested Candidates Can Contact: Sanjana 9251688426

Responsibilities To lead a team of Drug Safety Physicians working on ICSRs Projects. Conduct initial assessment and Medical Review of ICSR’s into the safety database. Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA code, suspect drug, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Causality Comment. Review and respond to any queries/comments from the Case Owner in the Safety database. Train and mentor PV associates on event capturing and general PV conventions as required. Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas. Escalate complex case issues on client products to Team Lead/Line Manager. To detail any follow-up information that is required and not already noted within the Safety database. To provide documentation of the review and case comments in Safety database in the Medical Review workflow. Maintain good knowledge of databases, regulations, guidelines, and SOP’s. Maintain strong GPVP and GCP knowledge. Following ICH, EMA, and FDA guidelines strongly and implementing them appropriately. To actively communicate and participate in internal project meetings. Participation in internal and external audits/inspections. Perform any other drug safety-related activities as assigned. Qualifications Degree in Medicine. PG degree in any discipline is an advantage, but not mandatory. Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety. Strong interpersonal and organizational skills to be a good team player. High sense of responsibility, dedication, and desire to work under pressure as required. Highly service oriented. Previous exposure to a corporate environment, pharma, and life sciences industry is an advantage. Good communication skills. Fluent in English- spoken and written. service-oriented

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing Years of Experience: 0-1 yrs 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? Ability to meet deadlines Ability to work well in a team Adaptable and flexible 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,Bachelor in Physiotherapy,BSc. Nursing

Job Description Regional Medical Advisor (RMA) – General & Specialty Medicine, East Region The RMA will serve as a key representative for our company, engaging with essential stakeholders in the field. The objective of our medical affairs team is to provide scientific expertise across identified regions, products, and therapy areas to these valued customers. Responsibilities And Primary Activities Scientific Expertise Develop and maintain a comprehensive understanding of the company's products, particularly in the cardiovascular therapeutic area, while staying updated on the latest medical advancements, clinical guidelines, and treatment protocols. Stakeholder Engagement Build and maintain relationships with Scientific Leaders (SLs), Key Decision Makers (KDMs), healthcare professionals, and academic institutions. Engage in scientific discussions, present clinical data, and provide educational support to Key Opinion Leaders (KOLs) regarding the company's products and therapeutic areas. Support to Medical Strategy Collaborate with the line manager to provide strategic inputs and expertise to product management. Medical Education Deliver scientific and medical education to internal stakeholders, including sales and marketing teams. Collaborate with the Medical Affairs team to develop and present training materials. Scientific Exchange Facilitate knowledge transfer between the company and external stakeholders by participating in medical conferences, advisory boards, and scientific meetings to gather insights and share data. Clinical Data Communication Interpret and communicate clinical trial data, real-world evidence, and other scientific information to healthcare professionals and regulators, ensuring compliance with regulations and company policies. Clinical Research Support Provide medical support for local studies, including identifying study sites for Investigator Initiated Trials. Cross-Functional Collaboration Work closely with Clinical Development, Regulatory Affairs, Marketing, and Market Access teams to provide scientific input, support clinical trial design, and align on medical communication plans. Medical Initiatives Support and lead medical projects aligned with the therapy area, involving strong stakeholder interaction. Medical Information Address medical inquiries and provide timely, accurate responses to healthcare professionals and other stakeholders, ensuring that medical information materials are current and compliant. Sales Force Training Train sales colleagues on assigned therapy areas and assist in pre-launch and launch training for new products. Compliance Adhere to legal, regulatory, and compliance guidelines, ensuring all activities are conducted ethically and in accordance with applicable laws. Overall, the RMA in Medical Affairs acts as a scientific expert and liaison between the company and external stakeholders, playing a crucial role in building scientific credibility, fostering relationships, and supporting the company's strategic objectives in the healthcare industry. Values and Behaviours Consistently demonstrate company values with a focus on excellence. Collaborate harmoniously with internal and external stakeholders. What You Must Have Educational Background A strong academic foundation in life sciences, such as a medical degree (MD) or doctorate (Ph.D.). Industry Experience At least 1 year of experience in the pharmaceutical cardiovascular therapy area, including roles in clinical research or medical affairs that expose the candidate to scientific and medical aspects of the industry. Therapeutic Area Expertise Demonstrated knowledge and expertise in the relevant cardiovascular therapeutic area, including experience with clinical trials and publications. Scientific and Clinical Knowledge Strong understanding of medical and scientific principles, including clinical trial design, data analysis, and interpretation, along with familiarity with relevant disease states and treatment guidelines. Communication and Relationship-Building Skills Excellent interpersonal, communication, and presentation skills are essential for effectively conveying scientific information to various stakeholders. Analytical and Problem-Solving Skills Ability to analyse complex scientific data, identify insights, and provide recommendations, particularly in interpreting clinical trial results and addressing medical inquiries. Adaptability and Flexibility Capability to work in dynamic environments, adapt to changing priorities, and travel frequently to engage with external stakeholders. Regulatory and Compliance Knowledge Familiarity with legal, regulatory, and compliance guidelines, including Good Clinical Practice (GCP) and ICH guidelines, as well as local regulations governing medical communications. 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 Advisory Board Development, Advisory Board Development, Clinical Development, Clinical Knowledge, Clinical Testing, Educational Program Development, Emergency Care, Good Clinical Practice (GCP), Healthcare Education, Health Economics Research, Investigator-Initiated Studies (IIS), Life Science, Management Process, Medical Affairs, Medical Communications, Medical Information Systems, Medical Marketing Strategy, Medical Policy Development, Medical Writing, Pharmacovigilance, Product Knowledge, Product Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Compliance Consulting {+ 5 more} Preferred Skills Job Posting End Date 08/31/2025 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 R350741