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Roles & Responsibilities• Oversee operation, administration, and maintenance of the Veeva Vault Safety system• Configure and customize Veeva Vault Safety to meet organizational and regulatory requirements• Implement and manage workflows for adverse event reporting, risk management, and safety data analysis• Ensure system compliance with global pharmacovigilance regulations (FDA, EMA, ICH, GVP)• Prepare and support submission of periodic safety reports and regulatory deliverables• Monitor regulatory updates and implement required system or process changes• Manage collection, processing, and analysis of safety data• Develop and generate safety reports for internal and external stakeholders• Ensure integrity, security, and confidentiality of pharmacovigilance data• Collaborate with clinical, regulatory, and IT teams to optimize system usage across drug development processes• Participate in cross-functional discussions on safety data trends and potential risks• Contribute to continuous improvement of pharmacovigilance systems and processesQualification• Bachelor’s or Master’s degree in Pharmacy, Nursing, Life Sciences, or a related disciplineExperience• 3–10 years of experience in Pharmacovigilance and Drug Safety• Hands-on experience with Veeva Vault Safety or similar safety database systemsSkills• Strong knowledge of global PV regulations and safety reporting requirements• Expertise in Veeva Vault Safety configuration, workflows, and data management• Excellent analytical and problem-solving skills• Proficiency in safety data analysis and reporting• Strong communication, collaboration, and stakeholder management skills• Ability to work independently as well as in a cross-functional team environmentAbout the OrganizationCognizant is a leading global professional services company helping clients transform their business, operating, and technology models for the digital era. With a strong focus on innovation, inclusion, and career growth, Cognizant supports organizations worldwide through industry-driven and technology-led solutions.

Roles & Responsibilities• Assist with overall safety trackers, applications, and tools implementation, support, configuration, and migration activities• Provide service to clients either as a support function to client project groups or as a standalone business• Ensure delivery of high-quality service to internal and external clients in a safe and cost-effective manner• Conduct project-specific configurations in safety applications/tools• Maintain and document trackers/applications/tools configuration based on requirements and updates• Evaluate proposed project ideas or software changes through technical impact analysis and estimated business value• Develop and document standard and ad hoc reports from safety trackers/applications/tools• Support and educate end users and sponsors as needed• Collaborate with training teams to develop safety application/tool-specific training modules• Document user requirements and ensure timely delivery in collaboration with technical partners• Provide guidance on use of standard safety trackers/tools, including advanced conditions and Standard MedDRA Queries (SMQ)• Conduct routine and ad hoc data extraction (e.g., PSURs, DSURs, 6-monthly listings)• Participate in data migration activities and related documentation• Support change management and user training for trackers/tools• Manage ticketing, issue resolution, and escalate issues as needed• Respond to mailbox queries and provide vendor management support• Train team members on technical and functional aspects of safety tools• Update departmental SOPs, working practices, and guidelines• Monitor tracker/tool failures and resolve issues promptly• Perform user acceptance testing and complete required documentation• Lead critical team projects and manage team workloadQualification• Degree in Life Sciences, IT, or Computing (relevant equivalent experience may be considered)Experience• Minimum 2 years in safety trackers/applications/tools operations support• Experience with validated document management systems and drug safety trackers (e.g., intake/SAE/ESR trackers, SharePoint, in-house tools)• Clinical background with clinical systems is preferredSkills• Strong technical and functional knowledge of PV systems• Good understanding of SQL and ticket support applications• Proficiency in Microsoft Office tools• Strong attention to detail and ability to handle multiple priorities• Good written and verbal communication skills• Ability to work collaboratively and provide peer supportAbout the CompanyFortrea is a global leader in clinical research and pharmacovigilance services, providing innovative solutions for drug safety, clinical trial operations, and regulatory compliance. With a presence in India and worldwide, Fortrea offers professionals exposure to advanced clinical technologies, validated systems, and global trial operations while fostering a collaborative and high-quality service-driven work culture.

Roles & Responsibilities• Lead safety case processing and support global safety evaluation activities• Monitor compliance with PVASC requirements for GSK and third parties including HSI reconciliation• Perform quality checks of adverse event reports in global safety databases and escalate issues• Maintain pharmacovigilance databases, EDMS, PVASC platforms, and shared systems• Collect, analyze, and document safety data from local operating companies• Generate standard safety listings and manage document archiving processes• Support regulatory inspections and internal audits under senior guidance• Contribute to SOPs, guidance documents, and process improvement initiatives• Collaborate with internal and external stakeholders with minimal supervisionQualification• Bachelor’s degree in life sciences, pharmacy, medicine, nursing, or related health scienceExperience• 5–9 years of pharmacovigilance or drug safety experience including ICSR processingSkills• Strong knowledge of pharmacovigilance regulations, GVP, and clinical safety documentation• Experience with safety databases and electronic case processing systems• Good understanding of medical terminology and MedDRA coding• Proficiency in MS Word, Excel, PowerPoint, SharePoint, and PowerBI• Strong organizational, analytical, and stakeholder management skillsAbout the CompanyGlaxoSmithKline (GSK) is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. GSK focuses on vaccines and specialty medicines to positively impact billions of patients worldwide while fostering a culture driven by integrity, innovation, and patient safety.

Roles & Responsibilities• Perform medical information contact center (MICC) activities and case intake• Process adverse event (AE) and adverse drug reaction (ADR) reports• Ensure timely, accurate, and compliant safety data entry• Follow global pharmacovigilance regulations and internal SOPs• Support safety surveillance and regulatory reporting activities• Maintain proper documentation and quality standardsQualification• B.Pharm / M.Pharm / BDSExperience• Freshers and experienced candidates can applySkills• Basic knowledge of pharmacovigilance or clinical research• Good communication and documentation skills• Understanding of GCP, ICH guidelines, and drug safety concepts• Willingness to learn and adapt in a regulated work environment• Attention to detail and quality-oriented approachAbout the OrganisationPharmazone is a growing organization in the pharmaceutical and clinical research domain, offering opportunities in clinical research and pharmacovigilance. The company provides structured learning, hands-on exposure, and clear career growth paths for freshers and experienced professionals in the life sciences industry.

Roles & Responsibilities• Prepare and review aggregate safety reports including PSUR, PADER, DSUR, and RMP• Ensure compliance with global pharmacovigilance regulations (ICH, EMA, US FDA)• Perform medical review and safety data analysis for periodic reports• Coordinate with cross-functional teams to ensure timely submissions• Maintain documentation in line with SOPs and regulatory timelines• Support audits and regulatory inspections as requiredQualification• Degree in Pharmacy (B.Pharm / M.Pharm)Experience• 1–3 years of experience in aggregate safety report writingSkills• Strong knowledge of pharmacovigilance processes and global safety reporting• Hands-on experience with PSUR, PADER, DSUR, and RMP• Excellent medical writing and analytical skills• Strong communication and coordination abilities• Ability to work independently and meet strict regulatory deadlinesAbout the OrganisationLambda Therapeutics is a growing pharmaceutical organization engaged in drug development and global regulatory activities. The company offers professionals exposure to international pharmacovigilance standards, collaborative cross-functional teams, and strong opportunities for career development in drug safety and regulatory writing.

Roles & Responsibilities• Perform end-to-end clinical data management activities for assigned studies• Review and evaluate clinical trial imaging and clinical data for accuracy and compliance• Collaborate with project teams to define study-specific edit checks• Run, review, and resolve data queries and discrepancies• Support study setup including database structure, specifications, and TF design• Coordinate receipt, integration, and processing of external and electronic clinical data• Maintain complete, accurate, and audit-ready study documentation• Track open data issues and ensure timely resolution• Ensure CDM activities comply with regulatory guidelines and internal SOPs• Participate in client meetings and cross-functional discussions• Continuously enhance technical and industry knowledge through trainingQualification• Bachelor’s degree in Life Sciences, Computer Science, or a related discipline• Equivalent clinical data management experience will be consideredExperience• Minimum 1 year of experience in Clinical Data Management (Pharma, Biotech, or CRO)Skills• Strong understanding of clinical trial terminology and CDM processes• Working knowledge of relational databases and data validation• SAS knowledge is desirable• Proficiency in MS Word, Excel, and Access• Strong analytical skills with high attention to detail• Excellent documentation, organizational, and communication skills• Ability to work independently and effectively in fast-paced team environmentsAbout the OrganisationClario is a global leader in clinical trial endpoint technology, delivering innovative imaging, cardiac safety, and digital endpoint solutions to support clinical trials worldwide. The company partners with leading pharmaceutical, biotech, and medical device organizations, offering professionals exposure to global studies, advanced technology platforms, and diverse therapeutic areas.

Role & Responsibilities • End-to-end ICSR processing • Safety case follow-up and submissions • Adhere to client and global regulatory guidelines • Conduct internal quality checks and documentation Qualification: B.Pharm / Life SciencesExperience: 1-3 years Skills • Knowledge of ICSR processing and safety case management • Familiarity with regulatory guidelines in Pharmacovigilance • Attention to detail and strong organizational skills • Ability to work in a compliance-driven, fast-paced environment About The Company • Accenture is a global leader in life sciences operations, focusing on regulatory services and pharmacovigilance. The company offers structured growth opportunities in the life sciences sector. Accenture fosters a diverse and inclusive work environment while collaborating with leading biopharma clients.

Role & Responsibilities • Translate Japanese safety cases to English • Prepare Japan HA E2B reports • Conduct case quality review, follow-ups, and submissions • Ensure SLA and quality compliance for Japan foreign cases Qualification: Life Sciences / Pharmacy / Any Graduate Language Requirement: Japanese (JLPT N5 or above)Experience: 1-3 years Skills • Japanese language proficiency (JLPT N5 or above) • Knowledge of Pharmacovigilance operations • Experience in case quality review and regulatory submissions • Attention to detail and compliance mindset About The Company • Accenture provides global exposure in pharmacovigilance, working with leading biopharma clients. The company fosters a collaborative and inclusive workplace. Accenture offers structured career growth opportunities and a focus on compliance-driven roles.

Role & Responsibilities • ICSR case intake and data entry • MedDRA coding and safety database management • Case processing and regulatory submissions • Compliance with global PV regulations (ICH, GVP)Qualification: B.Pharm / Life SciencesExperience: 0-1 year (Freshers eligible) Skills • Knowledge of Pharmacovigilance operations • Familiarity with MedDRA coding and safety databases • Attention to detail and compliance-driven mindset • Ability to work in rotational shifts About The Company • Accenture offers structured learning and growth opportunities in pharmacovigilance. • The company specializes in life sciences regulatory services and has a strong global presence. • Accenture works with leading biopharma clients and promotes an inclusive work culture.

Role & Responsibilities • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. • Review includes coding, assessment of seriousness, expectedness, and causality. • Write Company comments, follow-up questions, and analyze similar events. • Complete all required supporting documentation, such as trackers. • Support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues. • Review and provide input in periodic reports. • Review literature screening search strategies and review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings. Qualification • MD qualification is required. Experience • Proven ability to plan, organize, prioritize, and execute multiple tasks efficiently. Skills • Ability to work cross-culturally and cross-functionally, valuing teamwork. • Strong communication and presentation skills. • Advanced English skills, both verbal and written (at least B2 level). • Advanced knowledge of MS Office. About The Company • PrimeVigilance offers an opportunity for Medical Doctors to develop a career in Drug Safety.The company’s Pharmacovigilance Physician team operates across North America, Europe, and Asia, providing global pharmacovigilance services. PrimeVigilance is focused on creating a collaborative, high-quality environment for physicians interested in pharmacovigilance.

Role & Responsibilities • Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical and causality assessments. • Assess the seriousness, expectedness, and causality of reports. • Write company comments, follow-up questions, and perform analysis of similar events. • Complete required supporting documentation such as trackers. • Support the Qualified Person for Pharmacovigilance (QPPV) in evaluating safety issues (if not medically qualified). • Provide input for periodic reports. • Review literature screening search strategies and articles to determine safety findings or ICSRs/SAEs related to the relevant medicinal products. Qualification • MD (Medical Doctor) Experience • Experience in Pharmacovigilance, preferably with exposure to ICSR handling and safety reporting • Strong understanding of drug safety regulations and practices Skills • Ability to plan, organize, prioritize, and execute multiple tasks • Strong communication and presentation skills • Ability to work cross-culturally and functionally as part of a global team • Advanced English skills (both verbal and written), at least B2 level • Advanced knowledge of MS Office About The Company • PrimeVigilance is a global pharmacovigilance and drug safety service provider. The company offers an opportunity for medical doctors to build and develop their careers in drug safety.

Roles & Responsibilities: • Perform end-to-end pharmacovigilance case processing for clinical trial safety cases • Collect, assess, process, and submit adverse event (AE) and serious adverse event (SAE) reports • Ensure timely and accurate data entry in LSMV (LifeSphere MultiVigilance) database • Maintain compliance with global pharmacovigilance regulations (ICH-GCP, GVP, FDA, EMA) • Support signal detection activities and risk management assessments • Collaborate with cross-functional teams on safety queries and investigations • Stay updated with current drug safety guidelines and industry standards Qualification: • Bachelor’s degree in Life Sciences, Pharmacy, or related discipline Experience: • Minimum 2+ years of experience in pharmacovigilance case processing • Hands-on experience in Clinical Trial Safety Cases OR LSMV / Argus / Safety Databases Skills: • Strong analytical skills with high attention to detail • Excellent written and verbal communication skills • Proven commitment to quality, compliance, and patient safety About the Organisation: ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing patient safety and delivering high-quality clinical development solutions across the pharmaceutical and biotech industries.

Roles & Responsibilities • Perform end-to-end ICSR case processing for marketed products as per global regulations. • Assess seriousness, expectedness and causality and ensure timely global reporting. • Process literature ICSRs and maintain compliance with monitoring requirements. • Support aggregate reporting activities including PSURs and DSURs. • Maintain safety database integrity with hands-on experience in LSMV preferred. • Perform reconciliation activities and support KPI and SLA tracking. • Collaborate with medical, clinical and cross-functional teams on safety evaluations. • Support signal detection, risk management activities and identification of safety trends. • Participate in regulatory audits and inspections. • Train and mentor junior pharmacovigilance associates. • Review SOPs and contribute to continuous process improvement. Qualification • B.Pharm / M.Pharm, Pharm.D, BDS, B.Sc Nursing / M.Sc Nursing, BAMS / BHMS Experience • Minimum 4+ years of pharmacovigilance case processing experience. • Mandatory experience in Post-Marketing Surveillance (PMS). Skills • Strong knowledge of global pharmacovigilance regulations. • Hands-on experience with safety databases (LSMV preferred). • Expertise in ICSR processing for marketed products. • Experience with PSUR / DSUR and aggregate reports. • Familiarity with SDEA concepts and SLA / KPI management. • Audit and inspection readiness. • Excellent analytical, communication and documentation skills. • Proficiency in Microsoft Office tools. About the Company ICON plc is a global healthcare intelligence and clinical research organization delivering outsourced development and commercialization services to the pharmaceutical, biotechnology and medical device industries, supporting innovation and patient safety across the product lifecycle worldwide.

Roles & Responsibilities • Perform end-to-end ICSR processing from spontaneous, clinical, literature, and solicited sources • Handle case intake, triage, data entry, MedDRA and WHO-DD coding, narrative writing, QC, and follow-ups • Conduct systematic literature surveillance and generate compliant literature ICSRs • Ensure timely regulatory submissions to global health authorities (USFDA, EMA, MHRA, PMDA, etc.) • Support aggregate safety reports including PSUR, PBRER, and DSUR • Maintain compliance with global PV regulations, internal SOPs, and client procedures • Support internal, client, and regulatory audits including CAPA activities • Assist in signal detection and ongoing safety data review • Perform regulatory intelligence and safety trend monitoring • Collaborate with cross-functional and client teams in a consulting environment Qualification • Graduate or Postgraduate in Life Sciences • B.Pharm / M.Pharm / Biotechnology / Biology / Chemistry or related disciplines • Master’s degree preferred Experience • 1–5 years of experience in Pharmacovigilance or Drug Safety • Experience in global PV projects and regulatory submissions preferred Skills • Hands-on experience with safety databases such as Argus, ArisG, Veeva, or similar • Strong knowledge of global pharmacovigilance regulations (ICH, GVP, USFDA, EMA, MHRA) • Excellent communication, analytical, and documentation skills • Ability to work in a fast-paced consulting and client-facing environment About the Organisation Amarant Lifesciences Private Limited is a regulatory and pharmacovigilance consulting organization providing end-to-end drug safety and compliance solutions to global pharmaceutical and biotechnology clients, offering strong exposure to international regulatory projects and career growth opportunities.

Roles & Responsibilities • Respond to medical information queries from healthcare professionals, patients, and internal stakeholders via calls and emails • Provide accurate, balanced, and compliant scientific responses • Document and track medical inquiries as per SOPs and regulatory guidelines • Ensure adherence to quality standards, audit readiness, compliance, and turnaround time (TAT) • Coordinate with Pharmacovigilance, Quality Assurance, Regulatory Affairs, and Medical Affairs teams • Maintain data integrity, confidentiality, and regulatory compliance in a global pharma environment Qualification • B.Pharm / M.Pharm / PharmD • B.Sc / M.Sc (Life Sciences) Experience • Experience in Medical Information, MICC, Pharmacovigilance, Drug Safety, or Voice / Call Center process • Candidates from non-core voice process backgrounds with pharma education are encouraged to apply Skills • Strong verbal and written communication skills • Understanding of SOPs, compliance, and quality systems • Ability to handle scientific discussions with HCPs and patients • Experience working with global or international clients is an added advantage About the Organisation Mitocon Biopharma Pvt. Ltd. is a growing pharmaceutical and biotechnology company focused on innovation, regulatory compliance, and global healthcare solutions. The organization provides strong career-transition opportunities for pharmacy professionals to move into core pharmacovigilance and medical information roles.

Role & Responsibilities • Perform end-to-end ICSR case processing for marketed products in compliance with global regulations • Assess seriousness, expectedness, causality, and ensure accurate global reporting • Process literature ICSRs and maintain monitoring compliance • Support aggregate reporting activities including PSURs and DSURs • Maintain pharmacovigilance database integrity (LSMV experience preferred) • Conduct reconciliation activities and support KPI/SLA tracking • Collaborate with medical, clinical, and cross-functional teams on safety evaluations • Identify safety trends and support signal detection and risk management • Participate in regulatory audits and inspections • Train and mentor junior pharmacovigilance associates • Review SOPs and contribute to continuous PV process improvement Qualification • B.Pharm / M.Pharm / Pharm.D / BDS / B.Sc Nursing / M.Sc Nursing / BAMS / BHMS Experience • 4+ years of pharmacovigilance case processing experience • Experience in Post-Marketing Surveillance (PMS) • Strong knowledge of global pharmacovigilance regulations • Hands-on experience with safety databases (LSMV preferred) • Familiarity with SDEA concepts and SLA/KPI management Skills • Pharmacovigilance & Drug Safety Operations • ICSR Processing (Marketed Products) • Aggregate Reports (PSUR / DSUR) • Global Safety Reporting • Signal Detection (supporting role) • Audit & Inspection Readiness • Excellent analytical and communication skills • Proficiency in Microsoft OfficeBenefits • Competitive salary & performance-based rewards • Multiple annual leave entitlements • Comprehensive health insurance for employee & family • Retirement & long-term savings plans • Global Employee Assistance Program (TELUS Health) – 24/7 support • Life assurance coverage • Flexible benefits (childcare support, gym discounts, travel subsidies, wellness programs) • Inclusive, diverse, and harassment-free workplace About The Company • ICON Plc – A global leader in healthcare intelligence and clinical research, ICON provides comprehensive solutions across the clinical trial process. With a strong commitment to regulatory compliance and patient safety, ICON offers career advancement opportunities for professionals in pharmacovigilance and drug safety.

Roles & Responsibilities: • Ensure MAH pharmacovigilance compliance with EU GVP Modules and UK MHRA requirements • Act as operational PV representative for UK and EU markets • Support QPPV / UK QPPV in maintaining PV system oversight • Ensure PV agreements with partners, distributors, and service providers are in place • Provide oversight of outsourced PV providers (ICSRs, literature, signals, aggregate reports) • Monitor vendor performance against KPIs and SLAs and lead governance meetings • Ensure timely and compliant ICSR reporting to EudraVigilance, MHRA, and partners • Oversee PSUR/PBRERs, RMPs, signal management, and benefit–risk evaluations • Maintain MAH PV Quality Management System and ensure SOP compliance • Support PV inspections and audits (MHRA, EMA, partners) and manage CAPAs • Act as PV contact for Regulatory, Quality, and Commercial teams • Ensure safety information is accurately reflected in SmPC, PIL, and submissions Qualifications: • M.Pharma in Pharmacy Experience: • Proven pharmacovigilance experience within UK and/or EU • Experience working in an MAH environment • Hands-on experience managing outsourced/third-party PV providers Skills: • Strong regulatory and compliance mindset • Excellent vendor and stakeholder management skills • Strong documentation, review, and inspection readiness abilities • Ability to work independently and manage multiple priorities • Experience in generics and post-marketing PV • Exposure to global PV operations and EudraVigilance systems About the Organization: B&S Group is a global distribution and supply chain organization operating across pharmaceuticals and healthcare, with a strong focus on regulatory compliance, quality, and patient safety across international markets.

Roles & Responsibilities: • Report safety information from India and India cluster (South Asia countries) to Global Safety • Follow up with reporters for additional safety information • Review and manage safety mailbox for incoming reports • Perform monthly reconciliation and compliance checks from a pharmacovigilance perspective • Prepare and submit Periodic Safety Update Reports (PSURs) to regulatory authorities as per regulations • Gather requirements and prepare regulatory dossiers for new products, clinical trials, variations, and renewals • Prepare responses to regulatory authority queries and coordinate with global teams • Support preparation for regulatory authority and expert committee meetings • Prepare and follow up on regulatory submissions for South Asia countries • Prepare and update product labeling materials • Review promotional materials for compliance with approved product registrations • Ensure timely updates to regulatory databases • Update and maintain local SOPs • Update and renew safety agreements with partners, manufacturers, and distributors • Coordinate price updates and ensure timely entry into NPPA pricing database • Manage lifecycle maintenance activities and update commercial teams on key milestones Qualifications: • Bachelor’s degree in Pharmacy, Life Sciences, Microbiology, Chemistry, or related field Experience: • Minimum 1+ year experience in India Regulatory Affairs and Pharmacovigilance • Experience within pharmaceutical or biotechnology industry preferred Skills: • Knowledge of Indian regulatory and pharmacovigilance requirements • Strong documentation and dossier preparation skills • Ability to coordinate with global and cross-functional teams • Good communication and regulatory compliance understanding • Attention to detail and ability to manage multiple submissions About the Organization: Ferring Therapeutics is a global, research-driven biopharmaceutical company committed to developing innovative treatments in areas of high unmet medical need. The company focuses on maintaining the highest standards of quality, regulatory compliance, and patient safety while delivering life-changing therapies worldwide.

Roles & Responsibilities: • Perform medical assessments of client’s product ranges and evaluate adverse events • Conduct medical reviews of aggregate reports and prepare clinical expert statements • Detect signals for client’s medicinal products and manage risk management plans • Provide guidance and participate in follow-up of adverse events, offering backup medical support • Interact with staff at various levels to resolve issues during reviews • Contribute to enhancing pharmacovigilance processes and writing SOPs • Ensure compliance with local regulations and global pharmacovigilance requirements • Assist in developing SOPs for the department and clients, and communicate with clients and regulatory agencies if needed Qualifications: • Relevant degree in Life Sciences, Pharmacy, or related field Experience: • 0–1 year in pharmacovigilance or related field Skills: • Knowledge of local and national pharmacovigilance requirements • Strong communication and client interaction skills • Ability to work effectively with staff at various levels and functional areas • Marketing, business generation, direct sales, and client servicing skills About the Organization: This organization is a dynamic employment and recruitment services firm providing specialized healthcare and pharmacovigilance staffing solutions. They focus on regulatory compliance, quality processes, and client satisfaction while fostering a collaborative environment for professional growth.