1729 Pharmacovigilance Jobs - Page 4

About The Role 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 Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Drug Safety AssociateDrug 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 Qualification Bachelor of Pharmacy,Master of Pharmacy

We are looking for a highly skilled Medical Content Writer with 3 to 9 years of experience to join our team at Digilantern. The ideal candidate will have a strong background in medical writing and excellent communication skills. Roles and Responsibility Develop high-quality, engaging medical content for various platforms. Conduct research and interviews to gather information and insights. Collaborate with cross-functional teams to ensure consistency and accuracy. Edit and proofread content for clarity, grammar, and punctuation. Stay up-to-date with industry trends and developments. Meet deadlines and deliver content on time. Job Requirements Minimum 3 years of experience in medical writing or a related field. Strong knowledge of medical terminology and concepts. Excellent writing, editing, and communication skills. Ability to work independently and as part of a team. Strong research and analytical skills. Familiarity with content management systems and publishing software.

About The Role Skill required: Operations Support - Pharmacy Benefits Management (PBM) Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Claims team which is responsible for the administration of health claims. This team is involved in core claim processing such as registering claims, editing & verification, claims evaluation, and examination & litigation.The business processes, operations and interactions of third party administrators of prescription drug programs, understanding of the processes used to manage programs for payers, process and pay prescription drug claims, develop and maintain the formulary, contract with pharmacies and negotiate discounts and rebates with drug manufacturers. What are we looking for Ability to perform under pressureAdaptable and flexibleAbility to establish strong client relationshipWritten and verbal communicationPrioritization of workload Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

We are looking for a highly skilled and experienced Pharmacist to join our team at MAX Hospital in Noida. The ideal candidate will have 3 to 8 years of experience in the pharmaceutical industry, with a strong background in pharmacy practice. Roles and Responsibility Dispense medications to patients and provide counseling on their proper use. Manage inventory and maintain accurate records of prescriptions and dispensing activities. Collaborate with healthcare professionals to develop and implement medication therapy plans. Conduct patient assessments and monitor their response to medication therapy. Develop and implement pharmacy protocols and procedures. Participate in quality improvement initiatives to enhance patient care and safety. Job Requirements Hold a degree in Pharmacy (D.Pharm, B.Pharm, M.Pharm) from a recognized institution. Possess a minimum of 3 years of experience in pharmacy practice, preferably in a hospital setting. Demonstrate strong knowledge of pharmaceuticals, medications, and medical terminology. Exhibit excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and prioritize tasks is essential. Strong analytical and problem-solving skills are required.

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Specialist Qualifications: Master Degree in Life Sciences Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. 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 Qualification Master Degree in Life Sciences

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Sr Analyst Qualifications: Master Degree in Life Sciences Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Master Degree in Life Sciences

About The Role Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Analyst Qualifications: Master Degree in Life Sciences Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world s leading biopharma companies bring their vision to life and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements.Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningExperience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master Degree in Life Sciences

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.Develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for SDTM ProgrammingStatistical ProgrammingPython (Programming Language)Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersClinical EDC Design 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 Qualification BE

About The Role Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Ability to establish strong client relationshipAbility to handle disputes 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 Qualification Any Graduation

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical data SVS Analyst Qualifications: Any Graduation,BE,MCA Years of Experience: 3-5 Yrs About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement What are we looking for Clinical Database ProgrammingClinical Data ManagementOracle Procedural Language Extensions to SQL (PLSQL)Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamSAS ClinicalStructured Query Language (SQL Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Any Graduation,BE,MCA

About The Role Skill required: User-Generated Content Moderation - Content management Designation: Trust & Safety Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be responsible for analyzing and reviewing user profiles, audio, videos, and text-based content and/or investigating, escalating and/or resolving issues that are reported by users or flagged by the system. Due to the nature of the role, the individual may be exposed to flashing lights or contrasting light and dark patterns.Content moderation is meaningful work that helps keep the internet safe. It may also be challenging, at times. In the context of this role, individuals may be directly or inadvertently exposed to potentially objectionable and sensitive content (e.g., graphic, violent, sexual, or egregious). Therefore, content moderators need strong resilience and coping skills. We care for the health and well-being of our people and provide the support and resources needed to perform their role responsibilities. Active participation in Accentures well-being support program, designed specifically for the Trust & Safety community, provides valuable skills to promote individual and collective well-being. What are we looking for Review, classify and/or remove content according to client guidelines, using specific tools and channelsUnderstand and remain updated on changing client policies and guidelinesInvestigate, resolve, and relay complex content issues to the broader Trust and Safety teamStrong coping, emotional resilience, and stress-management skillsExcellent comprehension, communicationAbility to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policiesStrong attention to detailComfort synthesizing and analyzing information from multiple streamsStrong critical thinking and decision-making skills Roles and Responsibilities: Profile as per the Change Training Staffing Plan and Rate CardAdditional requirement customer-centric skills to support the growing needs of Global Support Operations (GSO) Qualification Any Graduation

Job Title : Customer Support Executive – Pharmaceutical Support Location: [Hi-TechCity ,Hyderabad ] Job Type: Full-Time Experience Level: 0– 1years Industry: Pharmaceuticals / Healthcare Education Required: B.Pharm or M.Pharm Job Description: We are looking for a qualified and dedicated Customer Support Executive with a B.Pharm or M.Pharm background to join our pharmaceutical support team. This role involves providing accurate medical information, supporting customers with product-related queries, and ensuring a smooth customer experience across all communication channels. Key Responsibilities: Respond to customer inquiries related to medicines, prescriptions, dosages, and product usage. Provide support via phone, email, chat, or CRM systems in a timely and professional manner. Explain pharmaceutical products, side effects, contraindications, and precautions clearly to both medical and non-medical clients. Maintain accurate records of customer interactions, transactions, comments, and complaints. Coordinate with medical teams, pharmacists, or internal departments for technical queries or escalations. Stay updated on all pharmaceutical products, medical terminologies, and current healthcare guidelines. Ensure compliance with company policies and healthcare regulations (e.g., D&C Act, GPP guidelines). Required Qualifications and Skills: Bachelor’s or Master’s degree in Pharmacy (B.Pharm or M.Pharm). Strong understanding of pharmaceutical terminologies and medical products. Excellent communication skills in English (additional regional languages are a plus). Ability to explain complex medical information in simple terms. Proficient in using computers, MS Office, and CRM tools. Customer-first mindset, empathetic attitude, and attention to detail. Preferred (Not Mandatory): Previous experience in customer support or healthcare communication roles. Knowledge of pharmacovigilance or medical coding will be an added advantage. What We Offer: Competitive salary package On-the-job training on medical products and CRM tools Health benefits and paid leave Opportunity to grow in a fast-evolving healthcare sector How to Apply: Send your resume to [hemanth@adrotechsolutions.in] with the subject line: “Application for Customer Support Executive – Pharma Background” Job Types: Full-time, Fresher Pay: ₹15,000.00 - ₹18,000.00 per month Benefits: Cell phone reimbursement Flexible schedule Health insurance Provident Fund Work Location: In person

About the job Our Team: Sanofi Global Hub 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 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 under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines. Essential job duties and responsibilities: 1) Participate with support 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) 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, Product and Disease ID Cards, 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, and 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/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables. About you Experience : >2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills : Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment. Technical skills : As applicable (including but not limited to 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-ver sed with computer applications ) Education : Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages : Excellent English language knowledge (to read, write and speak)

Coordinate and manage clinical trials from initiation to completion, ensuring compliance with regulatory guidelines and study protocols. Should have knowledge in Clinical Data Management EDC Edit Checks SAE Reconcillation Required Candidate profile Maintain study supplies, track data collection, and support data analysis, ensuring high-quality and ethical research practices throughout the study

The Infection Control Nurse at Manipal Hospitals will be responsible for monitoring and preventing infections within the healthcare facility. This role involves developing and implementing infection control policies, protocols, and practices to ensure the safety of patients, staff, and visitors. The nurse will conduct regular training sessions for healthcare personnel to promote awareness of infection control measures. Additionally, the Infection Control Nurse will collect and analyze data related to infection rates, investigate outbreaks, and report findings to the healthcare team and relevant authorities. Collaborating with multidisciplinary teams will be crucial for achieving the organization's infection control goals. Key Responsibilities: - Monitor and track infection rates and trends within the hospital. - Develop and implement evidence-based infection prevention and control policies. - Conduct regular audits and inspections to ensure compliance with infection control standards. - Provide education and training to healthcare staff on infection prevention practices. - Investigate infection outbreaks and implement appropriate control measures. - Maintain accurate records and documentation related to infection control activities. - Educate patients and their families on infection prevention strategies. - Collaborate with healthcare professionals to improve patient outcomes related to infections. Skills and Tools Required: - Registered Nurse (RN) license and a valid nursing practice certificate. - Certification in Infection Control (CIC) is preferred. - Strong knowledge of infection control practices and healthcare regulations. - Excellent analytical and problem-solving skills. - Strong communication and interpersonal skills for effective staff education and patient interaction. - Proficiency in data collection and analysis related to infections. - Familiarity with infection control software and electronic health records systems. - Ability to work in a fast-paced environment and manage multiple priorities. - Attention to detail and commitment to maintaining high standards of patient care. This position offers an opportunity to make a significant impact on patient safety and quality of care within a prestigious healthcare organization. Roles and Responsibilities About the Role: The Infection Control Nurse at Manipal Hospital, Yelahanka, plays a crucial role in preventing and controlling the spread of infections within the healthcare facility. This position involves implementing infection control policies, conducting training programs, and monitoring compliance with established protocols. You will work closely with various departments to ensure patient and staff safety while maintaining high standards of care. About the Team: You will be part of a dedicated and multidisciplinary team focused on enhancing patient safety and quality of care. The team consists of healthcare professionals who continuously collaborate to address infection prevention challenges. This supportive environment encourages knowledge sharing and professional growth while prioritizing the health and well-being of patients and staff alike. You are Responsible for: Conducting regular surveillance of infection rates and identifying areas for improvement. Developing and implementing infection prevention protocols and training programs for staff. Conducting audits and assessments to ensure adherence to infection control practices. Collaborating with healthcare providers to manage outbreaks and implement control measures. Providing education and resources to patients and families regarding infection prevention. To succeed in this role – you should have the following: A relevant nursing degree and certification in infection control or epidemiology. Strong knowledge of infection control practices, standards, and regulations. Excellent communication and interpersonal skills for effective collaboration. Analytical skills for data collection and interpretation. A proactive approach to problem-solving and the ability to work in a fast-paced environment.

Skill required: Clinical Data Operations - Clinical Database Testing Designation: Clinical Data Svs Analyst Qualifications: Master Degree in Life Sciences Years of Experience: 3 to 5 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 and enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Testing Team is dedicated to conduct through validation of all clinical trial database components ensuring that database meets quality standards while remaining cost effective. Their responsibilities include reviewing requirement specification, developing test scripts for carious testing types, performing data entry according to these scripts, executing test steps, documenting results and maintaining comprehensive records of all tested components in compliance with regulatory requirements. Design and test EDC databases, create and maintain User Acceptance Testing (UAT) procedures for EDC systems, including the creation of test plans, verification of requirements for databases, eCRFs, edit checks, extractions, and reports. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Ability to establish strong client relationship Agility for quick learning Experience with Clinical testing - Creation of test scripts for all types of UAT including eCRF UAT, Edit checks UAT, Clinical Data Model UAT and Reports listing UAT and execution of test steps Followed with strong documentation skills and Knowledge of regulatory guidelines such as GCP, ICH, 21 CRF Part 11 and GDRP. Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts

🌟 ClinEdify Solutions Pvt Ltd – Your Stand Starts Here! 🌟 🚀 A Bootstrap Revolution Built by Fighters, for Fighters Company : ClinEdify Solutions Pvt Ltd Industry : EdTech | Pharma & Healthcare Type : Bootstrap Startup (Built with zero funding, 100% purpose) Work Mode : Remote/Hybrid /Offline Open Positions : Multiple role WHO WE ARE ClinEdify isn't just a company; 💥 It's a movement of survivors 💥 It's a platform for warriors 💥 It's a second chance for those who thought it was too late. We are a bootstrap startup, running without investors or luxury. but fueled by passion, purpose & pain turned into power. Many of us here are: Fighting personal battles Living through an unpredictable family & financial crises Single parents, freshers, dropouts, breadwinners People who were told “you can’t” — but chose to say “I WILL.” WHY THIS MATTERS 📢 If you're struggling, you are not alone. ClinEdify is built by people just like you — not to survive, but to RISE. We believe that your situation doesn’t define your potential. Here, your energy, hunger to learn & mindset matter more than your degrees. WHAT WE’RE BUILDING We’re on a mission to train 1,00,000+ students in Clinical Research, Pharmacovigilance, Medical Coding & AI in Life Sciences. Provide job-ready skills for anyone willing to learn. Build India’s most trusted career platform for Pharma & Life Sciences OPEN ROLES 🔹 Admissions Counselors Talk to students, understand their dreams & guide them. 🔹 Sales & Growth Executives Help scale ClinEdify through honest conversations & value-driven sales. 🔹 Digital Creators (Content, Video, Design) No need for perfection, just creativity & willingness to learn. 🔹 Training Interns/working professionals (Life Sciences) If you're from Pharma, Biotech or Life Sciences—start training and grow into full-time trainers. 🔹 Operations Support Help us run backend work smoothly coordination, documentation, reports and more. 🔹 Internships Across All Domains Learn. Contribute. Grow. From the ground up. WHO SHOULD APPLY? ✅ You have zero income but maximum hunger to grow ✅ You’re facing unpredictable situations — financially, emotionally or mentally ✅ You’re a single parent, dropout, struggling fresher or someone starting over ✅ You want to make a real difference, not just get a job WHAT YOU GET 💼 Real Skill Development 🎓 Certificates & Career Boost 💰 Incentive-based Growth (Bootstrap model – earn as we grow) 🌱 Promotion Opportunities – We grow, you grow 🫂 Supportive Team – No ego. No corporate drama. Just real people helping each other. 💥 This is YOUR Stand. This is not a fancy job. It’s a chance to build something bigger — for yourself and for thousands of others. Ready to Take a Stand With Us? 📩 Email : info@clinedify.com 📱 WhatsApp : +91-9032560517 🌐 Visit : www.clinedify.com “We are not here to fit in. We are here to stand out — and rise above.” — Team ClinEdify #RiseWithClinEdify #SecondChance #WeAreHiring #OpportunityForAll #BootstrapStartup

We have urgent vacancies for pharmacist and sr. pharmacist for TATA 1 mg @Bigbasket in Chennai. Job Description Designation: Pharmacist & Sr. Pharmacist Job Locations- Mugalivakkam, Navalur, Medavakkam, Virugambakkam, Thoraipakkam, West Tambaram Key Responsibilities: . Customer support and prescription validation . OTC order processing and clarification calls . Inventory and order management . Picking, packing, and handover to delivery riders . Cash-on-delivery (COD) cash handling . Root Cause Analysis for delayed orders . Stock receiving, audits, and shrinkage control . Store operations and manpower coordination . End-to-end store and customer fulfillment management Preferred Qualifications: . Pharma or B. Pharma with valid state license . 1- 3+ years of pharmacist experience . Proficient in MS Office and system tools . Strong communication skills in English,Tamil. . Comfortable with shift and weekend work . Experience in team and inventory management.

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What You Will Do Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations. Lead triage and resolution of incidents within Safety ecosystem (e.g., Argus, LSMV, Aris G). Independently resolve recurring and complex L1/L2 issues Perform in-depth troubleshooting and guide resolution of recurring issues. Act as the first point of contact for major incidents or outages. Identify patterns from recurring tickets and initiate corrective actions. Work with platform teams to implement automation, monitoring, and process improvements. Mentor junior support engineers and lead knowledge-sharing sessions. Develop and maintain SOPs, troubleshooting scripts, and process checklists. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master's degree / Bachelor's degree and 5 to 9 years of experience in Computer Science, IT or related field Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Hands on experience ITSM tools like Service now or JIRA Good understanding of Pharmacovigilance process and knowledge on safety systems like (Argus, Arisg, LSMV etc.) Identify and escalate potential safety/compliance issues. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Experience with testing methodologies, tools, and automation practices. Experienced in Agile methodology Preferred Qualifications: Understanding of API integrations and middleware platforms (e.g., MuleSoft). Experience with cloud-based technologies and modern data architectures. Knowledge of automation tools or scripting (e.g., Python, PowerShell) for diagnostics. Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Experience in SDLC, including requirements, design, testing, data analysis, change control Certification: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and strategic thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and will be assigned third shift schedule (Overnight shift on a rotational basis). Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What You Will Do Let’s do this. Let’s change the world. In this vital role you will join a collaborative team implementing and supporting the next generation of safety platforms and supporting technologies. In this role, you will analyze and resolve issues with adverse event data and file transmissions across integrated systems, leveraging data analytics to identify trends, optimize workflows, and prevent future incidents. Collaborating closely with various teams, you will develop insights and implement solutions to improve system performance, ensuring reliable and efficient data flow critical to safety operations. Monitor, solve, and resolve issues related to adverse event data processing across the safety ecosystem. Triage and conduct detailed investigations into system disruptions, data anomalies, or processing delays to determine and nature and scope of the problem Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues and triage the issues and provide L1/L2 support Identify inefficiencies and propose data-driven solutions to optimize and enhance reliability. Present findings and recommendations to leadership, ensuring data-driven decision-making and clear transparency into system operations. Support compliance with Key Control Indicators (KCI) and chips in to overall process governance What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor’s degree and 2 to 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Demonstrated expertise in monitoring, troubleshooting, and resolving data and system issues. Good understanding of Pharmacovigilance process and knowledge on safety systems like (Argus, Arisg, LSMV etc.) Basic familiarity with ITSM tools like Service now or JIRA Identify and escalate potential safety/compliance issues. Familiarity with database technologies and querying tools, including SQL (Oracle SQL, PL/SQL preferred). Experience with testing methodologies, tools, and automation practices. Familiarity with regulatory compliance testing (e.g., FDA 21 CFR Part 11, GAMP Experienced in Agile methodology Preferred Qualifications: Understanding of API integrations and middleware platforms (e.g., MuleSoft). Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients Sharp learning agility, problem solving and analytical thinking Experienced in GxP systems and implementing GxP projects Experience in SDLC, including requirements, design, testing, data analysis, change control Certification: SAFe for Teams certification (preferred) Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Ability to deal with ambiguity and think on their feet Shift Information: This position requires you to work a later shift and will be assigned third shift schedule (Overnight shift on a rotational basis). Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

Nandadeep Eye Hospital is looking for Pharmacist - Sangli to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Vihaa Multi Speciality Hospital is looking for Pharmacist to join our dynamic team and embark on a rewarding career journey Compounding and dispensing medications, as prescribed by physicians. Monitoring customers drug therapies, advising interventions, and informing customers of any potential side effects. Instructing customers on how and when to take prescribed medications. Conducting health and wellness screenings. Providing immunizations, and other medical services, such as taking blood pressure, temperature measurements, and checking blood sugar levels. Keeping accurate customer records. Ensuring a safe and clean working environment. Completing operational requirements of the pharmacy, including verifying order entries, maintaining records of controlled substances, charges, and removing expired and/or damaged drugs from the pharmacys inventory. Adhering to applicable legal rules, regulations, and procedures governing pharmaceutical practice. Performing other administrative tasks when needed.

Pharmacovigilance Reporting Specialist - Hybrid - Sofia, Bulgaria We are currently seeking a Pharmacovigilance Reporting Specialist to join our diverse and dynamic team. As a Pharmacovigilance Reporting Specialist at ICON, you will be responsible for the timely and accurate preparation of pharmacovigilance reports, ensuring compliance with regulatory requirements and internal policies. Your expertise in data analysis and reporting will be crucial in supporting the organization s commitment to drug safety and patient well-being. The role is 60% office-based in Sofia, Bulgaria or Warsaw, Poland and requires approx. 3 days/week office presence. What You Will Be Doing: Preparing and submitting comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), in compliance with regulatory standards. Conducting thorough data analysis to identify trends and assess the safety profile of pharmaceutical products. Collaborating with cross-functional teams to ensure timely and accurate reporting of adverse events. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices to ensure compliance. Providing training and support to team members on pharmacovigilance reporting processes and requirements. Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred. Significant (4+ years) experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment. Project lead experience is required. Strong analytical skills with proficiency in data analysis tools and reporting software. Excellent communication and interpersonal skills, facilitating effective collaboration with internal and external stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. Excellent command in English. #LI-Hybrid #LI-MK2 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

About the job Our Team: Sanofi Global Hub 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 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 under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines. Essential job duties and responsibilities: 1) Participate with support 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) 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, Product and Disease ID Cards, 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, and 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 / Legal / Regulatory / corporate affairs departments to prepare relevant & customized deliverables. About you Experience : >2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry Soft skills : Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment. Technical skills : As applicable (including but not limited to 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-ver sed with computer applications ) Education : Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD) Languages : Excellent English language knowledge (to read, write and speak)

Pharmacovigilance Reporting Specialist - Hybrid - Sofia, Bulgaria 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 Reporting Specialist to join our diverse and dynamic team. As a Pharmacovigilance Reporting Specialist at ICON, you will be responsible for the timely and accurate preparation of pharmacovigilance reports, ensuring compliance with regulatory requirements and internal policies. Your expertise in data analysis and reporting will be crucial in supporting the organization s commitment to drug safety and patient well-being. The role is 60% office-based in Sofia, Bulgaria or Warsaw, Poland and requires approx. 3 days/week office presence. What You Will Be Doing: Preparing and submitting comprehensive safety reports, including periodic safety update reports (PSURs) and individual case safety reports (ICSRs), in compliance with regulatory standards. Conducting thorough data analysis to identify trends and assess the safety profile of pharmaceutical products. Collaborating with cross-functional teams to ensure timely and accurate reporting of adverse events. Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices to ensure compliance. Providing training and support to team members on pharmacovigilance reporting processes and requirements. Your Profile: Bachelors degree in life sciences, pharmacy, or a related field; advanced degree preferred. Significant (4+ years) experience in pharmacovigilance reporting or drug safety within a clinical or pharmaceutical environment. Project lead experience is required. Strong analytical skills with proficiency in data analysis tools and reporting software. Excellent communication and interpersonal skills, facilitating effective collaboration with internal and external stakeholders. A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities. Excellent command in English. #LI-Hybrid #LI-MK2 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others. 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.