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Role & Responsibilities Author and support aggregate safety reports including PSURs, PBRERs, RMPs and Addendums Perform ICSR data entry, processing and management in global safety databases Conduct literature searches for individual case safety reports and periodic reports Ensure compliance with internal SOPs and global pharmacovigilance regulations Coordinate with global affiliates and cross-functional stakeholders Support safety signal detection and ongoing risk management activities Qualification B.Pharm / M.Pharm Experience 2 – 4 years of pharmacovigilance experience Skills PSUR, PBRER, RMP and AddCo authoring ICSR case processing and literature review Knowledge of ICH, GVP, US FDA and EMA guidelines Scientific writing and documentation Attention to detail and time management Strong communication and problem-solving abilities About the Company Mega Lifesciences is a global healthcare and pharmaceutical organisation delivering evidence-based medicines and operating robust pharmacovigilance systems to ensure patient safety and regulatory compliance across international markets

Role & Responsibilities Ensure high quality and regulatory-compliant case processing by vendors Perform quality review of ICSRs and device event reports Review and update vendor SOPs and working procedures Monitor weekly and monthly quality data and identify training needs Review AE/SAE and device event reports for pre and post-marketed products Clarify medical issues, revise MedDRA coding and ensure accurate narratives Coordinate with vendors and internal medical teams for case resolution Support audits, inspections, CAPA documentation and vendor oversight Maintain vigilance documentation and archival processes Train and guide vendor vigilance staff Implement process improvements and corrective actions Qualification BS / MS / Doctorate in Pharmacy, Nursing or related healthcare discipline Experience Minimum 3 years in Pharmacovigilance or Materiovigilance Prior experience in ICSR or device event review preferred Skills Strong knowledge of global PV & MV regulations Experience with safety databases (LSMV, CATSWeb preferred) Excellent communication and interpersonal skills High attention to detail and strong organizational skills Ability to work cross-functionally and manage workflow priorities About the Company A global healthcare organization operating within Global Pharmacovigilance & Risk Management, focused on regulatory-compliant safety surveillance, risk management and medical device vigilance across international markets

About Role & Responsibilities • Lead delivery operations for pharmacovigilance and drug safety services • Ensure adherence to global pharmacovigilance standards and timelines • Collaborate with teams to manage client relationships and regulatory compliance Qualification • B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences Experience • 3+ years in pharmacovigilance or related operations roles Skills • Leadership and team management skills • In-depth knowledge of pharmacovigilance processes and regulations About the Company Arcolab is a leader in pharmacovigilance and drug safety services, offering comprehensive solutions to the pharmaceutical industry

About Role & Responsibilities • Process pharmacovigilance cases in various languages, including Japanese, Vietnamese, French, Arabic, or Persian • Ensure timely processing of adverse event reports in accordance with regulatory requirements • Collaborate with cross-functional teams to ensure accurate data entry and reporting Qualification • B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences Experience • Freshers welcome to apply Skills • Fluency in one or more of the listed languages • Attention to detail and strong analytical skills About the Company Clinovo is a global leader in clinical research, specializing in pharmacovigilance and medical writing

About Role & Responsibilities • Perform pharmacovigilance activities such as signal detection and risk management • Ensure compliance with regulatory requirements for drug safety • Assist in preparing safety reports and presenting findings Qualification • B.Pharm Experience • 0-2 years in pharmacovigilance Skills • Strong understanding of pharmacovigilance processes • Good communication and report writing skills About the Company Cosette Pharma specializes in the development and commercialization of pharmaceutical products

About role & responsibilities • Perform triage and initial validity assessment of adverse event cases • Process spontaneous, clinical trial, literature and authority safety reports • Enter safety data accurately into pharmacovigilance databases • Conduct initial ICSR assessments as per global regulatory requirements • Evaluate cases for expedited reporting timelines • Prepare and submit CIOMS I, MedWatch and XML safety reports • Draft and manage follow-up queries to collect missing information • Maintain audit-ready case documentation • Retrieve and review EVWEB company and non-company cases • Support additional pharmacovigilance activities as assigned Qualification • B.Pharm • M.Pharm • BDS • Life Science Graduate Skills • Strong written and verbal communication • High attention to detail • Basic understanding of pharmacovigilance and drug safety reporting • Ability to work within strict regulatory timelines • Willingness to learn global PV regulations Experience • Freshers and early-career professionals can apply Salary • ₹3,00,000 – ₹5,00,000 per annum (estimated) Benefits • Comprehensive training in global pharmacovigilance operations • Exposure to international regulatory standards and safety systems • Career growth within Cencora / PharmaLex • Inclusive and equal-opportunity work culture About the company • Cencora (PharmaLex India Private Limited) is a global healthcare services organization • Focused on pharmacovigilance, regulatory compliance and risk management • Committed to patient safety, diversity and inclusive workplace practices

About role & responsibilities • Work in Life Sciences R&D vertical supporting global pharmacovigilance operations • Create and manage ICSR case identification, data entry, MedDRA coding, case processing, submission and follow-ups • Monitor and assess safety of pharmaceutical products across clinical and post-marketing stages • Ensure compliance with global regulatory requirements and client guidelines • Analyse moderately complex safety data and develop appropriate solutions • Support detection, evaluation and prevention of adverse drug reactions • Manage small teams or work efforts when assigned • Collaborate with internal and client stakeholders • Work in rotational shifts as required Qualification • Bachelor of Pharmacy • Master of Pharmacy • MBBS Skills • Pharmacovigilance operations and ICSR processing • MedDRA coding and safety database management • Regulatory compliance knowledge • Analytical and problem-solving ability • Strong documentation and communication skills Experience • 7 to 11 years of experience in Pharmacovigilance / Drug Safety Salary • Salary Competitive (as per company standards) Benefits • Exposure to global life sciences and pharmacovigilance projects • Career growth and leadership opportunities • Professional and collaborative work environment About the company • Accenture is a global professional services company with strong capabilities in digital, cloud and security • Provides strategy, consulting, technology and operations services across 120+ countries • Serves global biopharma clients through advanced technology and intelligent operations centers

Key Responsibilities Lead and govern global PV safety systems, data marts, UAT and system validation Ensure data integrity, compliance, inspection readiness and regulatory reporting (PSUR, DSUR, PADER) Oversee EDC–Safety DB integrations and reporting solutions (QBE, dashboards) Drive automation, AI adoption and PV process innovation Develop SOPs, training programs and mentor teams Support audits, inspections and QPPV-delegated activities Required Skills & Experience Strong experience with Argus / ArisGlobal LifeSphere Knowledge of global PV regulations, SDLC and system validation Reporting tools: Cognos, Spotfire, Tableau; Oracle DB, PL/SQL, Python preferred Pharma / Health Authority experience mandatory Education Doctorate OR Master’s + 3 yrs OR Bachelor’s + 5 yrs OR Associate’s + 10 yrs OR High School + 12 yrs relevant experience

About the Role Join Accenture’s Life Sciences R&D team to support global drug safety operations. You will process Individual Case Safety Reports (ICSRs) and ensure compliance with international pharmacovigilance regulations. This role is ideal for freshers and early-career professionals entering pharmacovigilance and drug safety. Key ResponsibilitiesProcess ICSRs including case intake, data entry, MedDRA coding, submissions and follow-ups Maintain data accuracy, timelines and audit readiness Ensure compliance with SOPs and global regulatory requirements Support routine pharmacovigilance surveillance activities Eligibility Criteria Educational Qualification Bachelor of Pharmacy (B.Pharm) or Bachelor’s degree in Life Sciences Experience 0 to 1 year of experience (Freshers eligible) Skills Required Basic understanding of pharmacovigilance and drug safety concepts Good attention to detail and data accuracy Ability to follow SOPs and regulatory timelines Basic knowledge of MedDRA coding preferred Good communication and documentation skills Willingness to work in a process-driven, compliance-focused environment

About the Role The Deputy Manager – Pharmacovigilance Safety System (ARGUS) Administrator is responsible for managing and maintaining the safety database infrastructure to ensure compliant, accurate, and efficient pharmacovigilance operations. Key Responsibilities Manage system configuration, user access, workflow setup and system maintenance Monitor compliance and ensure data integrity within the ARGUS safety system Generate and review safety system reports and dashboards Support system validation activities and documentation Provide troubleshooting, user support and training Maintain system-related SOPs, documentation and audit readiness Ensure accurate safety data entry and adherence to regulatory timelines Collaborate with PV operations teams to optimize safety system performance Required Knowledge and Skills Strong understanding of pharmacovigilance regulations including ICH and GVP Knowledge of safety database administration and PV workflows Strong analytical, documentation and troubleshooting skills High attention to detail and organizational ability Excellent communication and training skills Ability to work in compliance with SOPs and quality standards Educational Qualification Bachelor’s or Master’s degree in Life Sciences, Pharmacy or a related discipline About the Company Amneal is a global pharmaceutical organization committed to quality, patient safety and an inclusive workplace culture.

About the Role The Executive – Pharmacovigilance & Drug Safety is responsible for managing signal detection, evaluation, documentation and communication activities to ensure patient safety and regulatory compliance. Key Responsibilities Prepare and maintain signal schedules as per SOPs Identify, analyze and evaluate safety signals from multiple data sources Assess benefit–risk impact and potential label change requirements Prepare product-specific ADR sheets Author Drug Safety Reports for validated signals Communicate signal findings to internal stakeholders Support cross-functional initiatives to enhance pharmacovigilance capabilities Stay updated with global regulatory guidelines related to signal management Ensure compliance with SOPs, timelines and quality standards Assist in development and revision of SOPs, templates and work instructions Deliver signal management training to internal teams Qualification Pharm D / Doctor of Pharmacy Skills and Knowledge Signal detection and evaluation Pharmacovigilance regulations Drug safety reporting Documentation management Strong analytical and communication skills About the Company Amneal is a global pharmaceutical company committed to patient safety, regulatory excellence, and a diverse and inclusive workplace.

About the role & responsibilities • Act as primary client interface for Safety & Pharmacovigilance services • Lead and manage Safety and PV teams across programs • Oversee delivery as per Safety Management Plans and contracted scope • Monitor quality, KPIs, productivity and drive performance improvement • Ensure timely safety reporting and regulatory compliance • Review study budgets, forecasts and invoicing • Serve as escalation point for sponsors • Lead PV projects and inspections readiness activities • Review protocols, CRFs, SAE forms and safety documents • Develop and approve SOPs, WIs and process improvements • Support business development, bids and proposal reviews • Provide PV training and expert consultation Qualification • Bachelor’s degree in Life Sciences / Pharmacy / Nursing / Healthcare Experience • Extensive leadership experience in Safety & Pharmacovigilance • CRO exposure preferred Skills • ICH-GCP and GVP regulations • Safety reporting operations • People and project management • Budgeting and financial oversight • Strong stakeholder communication About the company • Syneos Health is a global biopharmaceutical solutions organization working on most FDA-approved novel drugs

About the role & responsibilities • Support configuration and optimization of global safety databases • Perform UAT, system validation and safety data integrity checks • Generate and review safety outputs for PSUR, DSUR, PADER, audits and inspections • Configure reports, QBE searches and quality review processes • Support study integrations and EDC–safety database mappings • Drive automation and AI-enabled PV innovations • Develop training, SOPs and support regulatory inspections Qualification • Master’s degree • Bachelor’s degree with relevant PV experience accepted Experience • Pharmaceutical industry / health authority experience mandatory Skills • Argus / LifeSphere safety databases • Aggregate safety reporting (PSUR, DSUR, PADER) • PV analytics and data quality • UAT and system validation • Strong stakeholder communication About the company • Amgen is a global biopharmaceutical leader focused on innovation and patient safety

About the role & responsibilities • Perform triage and validity assessment of adverse event reports • Enter and process ICSRs in global safety databases • Assess cases for expedited reporting timelines • Prepare CIOMS, MedWatch and XML safety reports • Draft follow-up queries to obtain missing case information • Retrieve and review EVWEB cases • Maintain audit-ready safety documentation • Support additional pharmacovigilance activities Qualification • B.Pharm / M.Pharm • BDS • Life Science graduate Experience • Freshers and early-career candidates eligible Skills • Pharmacovigilance and ICSR processing knowledge • Strong communication skills • High attention to detail • Ability to meet regulatory timelines About the company • Cencora (PharmaLex India Private Limited) is a global healthcare services organization focused on drug safety and regulatory compliance

About the role & responsibilities • Execute global Pharmacovigilance audit programs • Conduct audits of CROs, vendors, affiliates and internal PV sites • Manage IAOD and track CAPA closures and deviations • Review and prepare Pharmacovigilance SOPs • Support corporate and regulatory inspections • Maintain LMS training documentation • Prepare monthly quality and compliance reports • Ensure adherence to global PV quality systems Qualification • M.Pharm • BDS Experience • 2+ years in Pharmacovigilance QA, PSUR or Signal Management Skills • Pharmacovigilance auditing • Global PV regulations and quality systems • Documentation and compliance management • Strong English communication • Cross-functional coordination About the company • Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company with global presence

About the role & responsibilities • Support development and execution of global PV audit programs • Conduct audits for CROs, vendors, affiliates and internal PV sites • Manage audit observation database and CAPA tracking • Review and update pharmacovigilance SOPs • Support corporate and regulatory inspections • Maintain training and LMS records • Prepare monthly quality and compliance reports • Ensure adherence to global PV quality systems Qualification • M.Pharm • OR BDS Experience • Minimum 2 years experience in PV Quality Assurance • OR PSUR preparation / Signal Management Skills • PV auditing & compliance • CAPA management • SOP documentation • Regulatory PV knowledge • Communication & coordination skills About the company • Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company with global operations and strong focus on quality and innovation

About the role & responsibilities • Lead and manage pharmacovigilance safety teams • Oversee ICSR case processing, quality and regulatory compliance • Manage safety projects, deliverables and timelines • Monitor workload distribution, productivity and performance metrics • Review safety budgets, expenses and invoicing • Ensure compliance with GVP, ICH, GCP and global PV regulations • Support audits, inspections and CAPA activities • Review clinical protocols, CRFs, SAE forms and safety documentation • Support SOP development, process improvements and business development Qualification • Bachelor’s degree in Life Sciences / Biological Sciences / Healthcare / Nursing Experience • Minimum 8 years pharmacovigilance experience • Minimum 5 years people management experience • CRO experience preferred Skills • ICSR management and safety project leadership • ARGUS / ARISg Safety database expertise • Advanced MS Excel skills • SQL / Power BI knowledge (preferred) • Strong communication, leadership and client management skills About the company • Syneos Health is a global biopharmaceutical solutions organization operating in 110+ countries, supporting majority of FDA and EMA approved products

Roles & Responsibilities • Perform end-to-end pharmacovigilance case processing using Argus • Analyze, code, and enter safety data accurately • Handle all stages of case processing including triage, data entry, review, and follow-up • Ensure compliance with global and local PV regulations, SOPs, and Patient Safety policies • Execute and track follow-up procedures • Support implementation of new safety systems and process improvements • Contribute to a performance-driven work culture • Work collaboratively to meet strict timelines • Maintain clear written and verbal communication Qualification • B.Pharm(Bachelor of Pharmacy), B.Sc (Life Sciences), M.Pharm (Master of Pharmacy), M.Sc (Life Sciences) Experience • 1 to 4 years of Pharmacovigilance case processing experience Skills • Hands-on experience with Argus safety database • Knowledge of pharmacovigilance workflows and regulations • Strong analytical and data interpretation skills • Excellent written and verbal communication skills • Ability to work in a team and meet timelines About the Company Tata Consultancy Services (TCS) is a leading global IT services, consulting, and business solutions organization under the Tata Group, delivering end-to-end life sciences and pharmacovigilance solutions to global healthcare clients.

Role & Responsibilities • Act as US/EU local safety office and FDA/EMA point of contact • Submit ICSRs to FDA, EMA, and business partners • Perform case review, quality checks, and escalation of safety issues • Ensure timely expedited safety reporting • Support vendor oversight for case intake, triage, processing, and quality metrics • Conduct clinical trial and business partner reconciliations • Manage ICSR intake, triage, data entry queries, and E2B support • Support audit readiness, health authority inspections, and internal audits • Assist in PV training delivery and delegated QPPV activities Qualifications & Experience • Bachelor’s degree with 2+ years of pharmacovigilance experience, or • Associate degree with 6+ years of relevant experience, or • High school diploma/GED with 8+ years of pharmacovigilance experience Skills • Strong knowledge of global pharmacovigilance regulations • Experience in ICSR case processing and reporting • Proficiency in safety databases and MS Office tools • High attention to detail and compliance orientation About the Company • Amgen is a global biopharmaceutical leader delivering innovative therapies and maintaining world-class pharmacovigilance operations