875 Pharmacovigilance Scientist jobs in India
Senior Pharmacovigilance Scientist
110001 Delhi, Delhi
₹110000 Annually
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Posted 4 days ago
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Job Description
Our client is seeking a highly skilled and motivated Senior Pharmacovigilance Scientist to join their growing pharmaceutical team. This is a hybrid role, requiring a balance of remote work flexibility and in-office collaboration. You will play a pivotal role in ensuring the safety of our client's pharmaceutical products by monitoring, detecting, and assessing adverse events. This position involves detailed case processing, signal detection, risk management planning, and contributing to regulatory submissions. The ideal candidate will have a strong understanding of pharmacovigilance principles, regulatory requirements (e.g., ICH guidelines), and drug safety databases. You will be responsible for evaluating the safety profile of investigational and marketed products, identifying potential safety signals, and recommending appropriate risk mitigation strategies. This role requires meticulous attention to detail, strong analytical and scientific reasoning skills, and the ability to work effectively both independently and as part of a collaborative team. You will collaborate closely with clinical development, regulatory affairs, and medical affairs departments to ensure a comprehensive approach to drug safety. Your contributions will be crucial in safeguarding public health and maintaining regulatory compliance. We are looking for an individual who is passionate about patient safety and committed to upholding the highest standards in pharmacovigilance.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Conduct detailed safety reviews of clinical trial data and post-marketing surveillance data.
- Process and evaluate adverse event reports, ensuring accuracy and completeness.
- Perform signal detection activities to identify potential new safety concerns.
- Contribute to the development and implementation of risk management plans (RMPs).
- Prepare and review aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs).
- Collaborate with cross-functional teams to ensure timely and accurate safety reporting to regulatory authorities.
- Maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines.
- Participate in safety team meetings and provide scientific input on drug safety issues.
- Contribute to the development and validation of safety databases and tools.
- Support regulatory submissions by providing safety data and analyses.
Qualifications:
- Master's or Doctoral degree in Pharmacy, Medicine, Life Sciences, or a related healthcare field.
- Minimum of 5 years of experience in pharmacovigilance or drug safety.
- In-depth knowledge of pharmacovigilance principles, regulatory requirements (FDA, EMA, ICH), and safety database systems.
- Experience with signal detection methodologies and aggregate reporting.
- Strong analytical and scientific writing skills.
- Excellent understanding of clinical trial processes and pharmaceutical development.
- Ability to work effectively in a hybrid work environment and collaborate with diverse teams.
- Meticulous attention to detail and commitment to data accuracy.
- Strong communication and interpersonal skills.
- Proficiency in common office software and safety databases.
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0
Senior Pharmacovigilance Scientist
201301 Noida, Uttar Pradesh
₹1000000 Annually
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Posted 8 days ago
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Job Description
Our client, a prominent pharmaceutical company, is actively searching for a dedicated Senior Pharmacovigilance Scientist to join their safety surveillance team in Noida, Uttar Pradesh, IN . This critical role involves the comprehensive assessment, management, and reporting of adverse events associated with pharmaceutical products. You will play a pivotal part in ensuring patient safety and regulatory compliance by meticulously analyzing safety data, identifying potential risks, and contributing to risk management plans. The successful candidate will possess a strong medical or scientific background, excellent analytical skills, and a deep understanding of global pharmacovigilance regulations.
Key Responsibilities:
Qualifications:
This role requires a professional who is dedicated to upholding the highest standards of drug safety and regulatory compliance. The position is based in our client's office in Noida, Uttar Pradesh, IN , and requires a dedicated, on-site presence. You will be an integral part of a team committed to ensuring the safety and well-being of patients worldwide.
Key Responsibilities:
- Collect, process, and evaluate individual case safety reports (ICSRs).
- Conduct signal detection and safety data analysis to identify potential safety issues.
- Prepare and review periodic safety update reports (PSURs) and other regulatory documents.
- Collaborate with clinical development, regulatory affairs, and medical affairs teams on safety-related matters.
- Contribute to the development and implementation of risk management plans (RMPs).
- Ensure compliance with global pharmacovigilance regulations and company policies.
- Participate in safety strategy discussions and provide input on clinical trial designs from a safety perspective.
- Train junior staff on pharmacovigilance processes and procedures.
- Represent the pharmacovigilance department in cross-functional meetings.
Qualifications:
- M.B.B.S., M.Pharm, Pharm.D., Ph.D., or equivalent degree in a life science or healthcare field.
- Minimum of 5 years of experience in pharmacovigilance or drug safety.
- In-depth knowledge of global regulatory requirements for pharmacovigilance (e.g., FDA, EMA, CIOMS).
- Experience with safety databases and reporting tools (e.g., Argus Safety, ArisG).
- Strong analytical and critical thinking skills for data evaluation.
- Excellent written and verbal communication skills.
- Ability to work effectively in a team environment and manage multiple priorities.
- Detail-oriented with a strong commitment to patient safety.
This role requires a professional who is dedicated to upholding the highest standards of drug safety and regulatory compliance. The position is based in our client's office in Noida, Uttar Pradesh, IN , and requires a dedicated, on-site presence. You will be an integral part of a team committed to ensuring the safety and well-being of patients worldwide.
This advertiser has chosen not to accept applicants from your region.
1
Senior Pharmacovigilance Scientist
400001 Mumbai, Maharashtra
₹1500000 Annually
WhatJobs
Posted 15 days ago
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Job Description
Our client, a leading global pharmaceutical company, is seeking an experienced Senior Pharmacovigilance Scientist to join their dedicated safety surveillance team. This is a fully remote position, offering the flexibility to work from anywhere within India. The successful candidate will play a critical role in ensuring the safety of our products by monitoring, evaluating, and reporting adverse event data. You will contribute to signal detection, risk assessment, and the development of risk management plans. This role requires a strong scientific background, meticulous attention to detail, and a thorough understanding of regulatory requirements for pharmacovigilance. Key responsibilities include:
- Performing case processing and medical review of adverse event reports from various sources.
- Conducting in-depth analysis of safety data to identify potential safety signals and trends.
- Contributing to the preparation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and other regulatory submissions.
- Participating in cross-functional teams to assess product risks and benefits.
- Developing and maintaining safety databases and ensuring data integrity.
- Interpreting and applying global regulatory guidelines related to pharmacovigilance.
- Collaborating with clinical development, regulatory affairs, and medical affairs teams on safety-related matters.
- Contributing to the development and implementation of pharmacovigilance procedures and policies.
- Assisting in the preparation of investigator brochures and clinical study protocols from a safety perspective.
- Providing expert input for risk management plans and their implementation.
- Engaging in literature reviews for emerging safety information.
- Advanced degree in Pharmacy, Medicine, Life Sciences, or a related healthcare field (e.g., Pharm.D., M.D., M.Sc.).
- Minimum of 5 years of experience in pharmacovigilance or drug safety, with a strong understanding of signal detection and risk management.
- Comprehensive knowledge of global regulatory requirements for pharmacovigilance (e.g., FDA, EMA, ICH guidelines).
- Proven experience in medical case review and aggregate safety report writing (PSURs, DSURs).
- Excellent analytical, critical thinking, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to present complex scientific information clearly.
- Proficiency in using safety databases and pharmacovigilance software.
- Ability to work independently and manage workload effectively in a remote setting.
- Detail-oriented with a commitment to accuracy and compliance.
This advertiser has chosen not to accept applicants from your region.
2
Senior Pharmacovigilance Scientist
411001 Pune, Maharashtra
₹1600000 Annually
WhatJobs
Posted 18 days ago
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Job Description
Our client, a prominent pharmaceutical company, is seeking a highly experienced Senior Pharmacovigilance Scientist to join their fully remote safety surveillance team. This critical role involves ensuring the safety of their medicinal products by monitoring adverse events, evaluating safety data, and contributing to regulatory submissions. You will play a key part in risk management and benefit-risk assessment activities, working collaboratively with internal and external stakeholders. The ideal candidate possesses extensive knowledge of pharmacovigilance principles, regulatory requirements, and robust data analysis skills.
Key Responsibilities:
Key Responsibilities:
- Oversee and conduct safety data review and signal detection activities for assigned products.
- Author and contribute to the development of aggregate safety reports, such as Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs).
- Collaborate with clinical development, regulatory affairs, and medical affairs teams on safety-related matters.
- Ensure compliance with global pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).
- Lead and participate in safety assessment meetings, providing expert analysis and recommendations.
- Contribute to the development and implementation of pharmacovigilance strategies and processes.
- Perform literature reviews to identify relevant safety information and emerging trends.
- Manage and mentor junior pharmacovigilance staff.
- Act as a subject matter expert on safety data interpretation and regulatory requirements.
- Participate in health authority inspections and inquiries related to drug safety.
- Contribute to the development and maintenance of safety databases and systems.
- Review and approve safety-related documents and communications.
- Advanced degree (e.g., Pharm.D., M.S., Ph.D.) in a life science, pharmaceutical science, or medical field.
- Minimum of 7 years of experience in pharmacovigilance, drug safety, or a related pharmaceutical safety role.
- In-depth knowledge of global pharmacovigilance regulations, guidelines, and best practices.
- Proven experience in authoring aggregate safety reports (PBRERs, DSURs).
- Strong understanding of clinical trial processes and the interpretation of clinical safety data.
- Experience with safety databases (e.g., Argus, ArisG) and adverse event reporting systems.
- Excellent analytical, critical thinking, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to present complex information clearly.
- Ability to work independently and collaboratively in a fully remote team environment.
- Experience in specific therapeutic areas is a plus.
- Proficiency in medical terminology and disease states.
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3
Remote Senior Pharmacovigilance Scientist
160001 Chandigarh, Chandigarh
₹120000 Annually
WhatJobs
Posted 1 day ago
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Job Description
Our client, a leading pharmaceutical company dedicated to advancing global health, is seeking a highly skilled and experienced Senior Pharmacovigilance Scientist to join their fully remote team. This critical role focuses on ensuring the safety of medicinal products through rigorous monitoring, analysis, and reporting of adverse events. The ideal candidate possesses a deep understanding of drug safety regulations and a commitment to patient well-being.
Key Responsibilities:
Key Responsibilities:
- Conduct thorough case processing and medical assessment of adverse event reports from various sources, ensuring timely and accurate data collection.
- Perform signal detection and evaluation activities, identifying potential safety issues related to assigned products.
- Prepare and review aggregate safety reports (e.g., PADERs, DSURs) in accordance with global regulatory requirements.
- Contribute to the development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs, on safety-related matters.
- Interpret and apply global pharmacovigilance regulations and guidelines to ensure compliance.
- Participate in internal and external audits and inspections related to pharmacovigilance activities.
- Develop and deliver training on pharmacovigilance processes and requirements to internal stakeholders.
- Contribute to the development and improvement of pharmacovigilance systems and processes.
- Stay abreast of evolving scientific literature and regulatory landscapes impacting drug safety.
- Represent the company in safety-related discussions with regulatory authorities and external partners.
- Advanced degree (M.D., Pharm.D., Ph.D., M.Sc.) in a relevant life science or healthcare field.
- Minimum of 5 years of progressive experience in pharmacovigilance or drug safety within the pharmaceutical industry.
- In-depth knowledge of global regulatory requirements for pharmacovigilance (e.g., FDA, EMA, ICH guidelines).
- Proven experience in adverse event case processing, signal detection, and aggregate reporting.
- Strong medical assessment skills and the ability to critically evaluate scientific data.
- Excellent analytical, problem-solving, and critical thinking abilities.
- Exceptional written and verbal communication skills, with the ability to articulate complex safety information clearly.
- Proficiency with pharmacovigilance databases and safety reporting systems.
- Demonstrated ability to work independently and collaboratively in a remote, global team environment.
- Experience with RMP/REMS development is highly desirable.
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4
Remote Senior Pharmacovigilance Scientist
560001 Bangalore, Karnataka
₹1800000 Annually
WhatJobs
Posted 7 days ago
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Job Description
Our client, a prominent global pharmaceutical company, is seeking an experienced Senior Pharmacovigilance Scientist to join our fully remote safety surveillance team. This critical role involves monitoring, assessing, and reporting on the safety of our pharmaceutical products worldwide. You will be instrumental in ensuring regulatory compliance, safeguarding public health, and contributing to the development of robust safety profiles for our innovative medicines. The ideal candidate will possess a strong background in pharmacology, toxicology, or a related life science, combined with extensive experience in pharmacovigilance, regulatory affairs, and adverse event reporting. This remote position offers the flexibility to contribute significantly to patient safety from your home office.
Responsibilities:
Responsibilities:
- Conduct comprehensive safety assessments of assigned pharmaceutical products, including analysis of adverse event data.
- Prepare, review, and submit aggregate safety reports (e.g., PBRERs, DSURs) to regulatory authorities in accordance with global guidelines.
- Monitor emerging safety signals and perform signal detection activities, leading to appropriate risk management strategies.
- Contribute to the development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
- Collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, to ensure integrated safety strategies.
- Respond to safety inquiries from regulatory agencies, healthcare professionals, and internal stakeholders.
- Participate in safety labeling updates and ensure accurate communication of product risks.
- Review and assess Investigator's Brochures, clinical trial protocols, and study reports for safety-related information.
- Contribute to the development and implementation of pharmacovigilance policies, procedures, and systems.
- Stay current with global pharmacovigilance regulations, guidelines, and best practices.
- Ph.D. or Pharm.D. degree in Pharmacy, Medicine, Toxicology, or a related life science field.
- Minimum of 5-7 years of progressive experience in pharmacovigilance, drug safety, or a related pharmaceutical safety role.
- In-depth knowledge of global regulatory requirements for pharmacovigilance (e.g., FDA, EMA, CIOMS).
- Proven experience in preparing and submitting aggregate safety reports and managing safety databases.
- Strong understanding of clinical trial processes and the assessment of adverse events.
- Excellent analytical, critical thinking, and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex scientific and regulatory information clearly.
- Ability to work independently, manage multiple projects, and meet strict deadlines in a remote work environment.
- Experience with pharmacovigilance databases and safety reporting systems is essential.
- This is a fully remote position, requiring a dedicated home office setup and the ability to connect reliably.
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5
Senior Pharmacovigilance Scientist - Remote
201003 Ghaziabad, Uttar Pradesh
₹1300000 Annually
WhatJobs
Posted 7 days ago
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Job Description
Our client is seeking a highly experienced Senior Pharmacovigilance Scientist to join their global safety surveillance team. This is a fully remote position, offering the flexibility to work from anywhere. You will play a critical role in ensuring the safety and efficacy of pharmaceutical products by monitoring, evaluating, and reporting adverse events. Responsibilities include performing signal detection and assessment, contributing to regulatory submissions, and developing safety monitoring plans. You will collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, to manage product safety profiles. The ideal candidate will have a strong background in pharmaceutical sciences, clinical research, or a related healthcare discipline, with extensive experience in pharmacovigilance. A deep understanding of global regulatory requirements (e.g., FDA, EMA) for drug safety is essential. Excellent analytical, written, and verbal communication skills are crucial for authoring safety reports and communicating findings to stakeholders. You should be proficient in using pharmacovigilance databases and safety reporting systems. This remote role requires self-motivation, excellent time management, and the ability to work independently while maintaining high standards of quality and compliance. Join a leading pharmaceutical company committed to patient safety and advancing healthcare. This role offers a significant opportunity to impact global drug safety efforts from a remote setting.
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6
Remote Senior Pharmacovigilance Scientist
560001 Bangalore, Karnataka
₹130000 Monthly
WhatJobs
Posted 15 days ago
Job Viewed
Job Description
Our client is looking for an experienced Senior Pharmacovigilance Scientist to join their dedicated, remote-first team. In this crucial role, you will contribute to ensuring the safety and efficacy of pharmaceutical products by meticulously monitoring, collecting, and analyzing adverse event data. The Senior Pharmacovigilance Scientist will be responsible for case processing, signal detection, regulatory reporting, and contributing to the preparation of aggregate safety reports. You will play a key part in risk management activities and the development of safety strategies for assigned products. This position requires a thorough understanding of global regulatory requirements related to pharmacovigilance, including GVP guidelines. The ideal candidate will have a strong clinical or scientific background, with expertise in drug safety surveillance. Responsibilities include conducting literature reviews for safety information, assessing causality of adverse events, and collaborating with internal teams (e.g., Regulatory Affairs, Clinical Development) and external stakeholders (e.g., healthcare professionals, regulatory authorities). A proven ability to interpret complex safety data, identify potential safety signals, and recommend appropriate actions is essential. The successful applicant will possess excellent written and verbal communication skills, strong analytical abilities, and meticulous attention to detail. Experience with pharmacovigilance databases and safety reporting systems is required. A minimum of 5 years of direct experience in pharmacovigilance within the pharmaceutical industry is necessary. A Pharm.D., M.D., Ph.D., or Master's degree in a relevant life science or health-related field is preferred. This remote role offers a significant opportunity to impact patient safety on a global scale while enjoying the benefits of a flexible, work-from-home environment. Proactive engagement, independent problem-solving, and efficient time management are key attributes for success in this position.
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7
Remote Senior Pharmacovigilance Scientist
122001 Gurgaon, Haryana
₹95000 Annually
WhatJobs
Posted 18 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly skilled and dedicated Remote Senior Pharmacovigilance Scientist to join their global safety team. This is a critical, fully remote role that allows you to contribute significantly to drug safety monitoring and risk management from the comfort of your home office anywhere in India. You will be responsible for the ongoing safety surveillance of pharmaceutical products, including signal detection, risk assessment, and the development of safety strategies. The ideal candidate will possess a strong scientific background, a deep understanding of regulatory requirements for pharmacovigilance, and excellent analytical and communication skills.
Key responsibilities include:
The successful candidate will hold a Master's degree or PhD in Pharmacy, Medicine, Public Health, or a related life science discipline, with a minimum of 6 years of direct experience in pharmacovigilance. Proven experience in signal detection, risk assessment, and regulatory reporting is essential. A thorough understanding of global pharmacovigilance regulations and guidelines is required. Excellent written and verbal communication skills, strong analytical abilities, and proficiency in safety databases and regulatory submission tools are mandatory. This remote position requires self-motivation, excellent time management, and the ability to work effectively independently.
Key responsibilities include:
- Performing aggregate safety data review, including periodic safety update reports (PSURs) and development safety update reports (DSURs).
- Identifying, evaluating, and characterizing safety signals from various data sources (e.g., spontaneous reports, clinical trials, literature).
- Conducting risk-benefit assessments and contributing to risk management plans (RMPs).
- Collaborating with clinical development, regulatory affairs, and medical affairs teams to ensure comprehensive safety assessments.
- Preparing safety documents for regulatory submissions and meetings.
- Ensuring compliance with global pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).
- Participating in cross-functional teams for new drug development and post-marketing safety activities.
- Responding to regulatory authority inquiries related to drug safety.
- Contributing to the development and implementation of departmental SOPs and processes.
- Mentoring junior members of the pharmacovigilance team.
The successful candidate will hold a Master's degree or PhD in Pharmacy, Medicine, Public Health, or a related life science discipline, with a minimum of 6 years of direct experience in pharmacovigilance. Proven experience in signal detection, risk assessment, and regulatory reporting is essential. A thorough understanding of global pharmacovigilance regulations and guidelines is required. Excellent written and verbal communication skills, strong analytical abilities, and proficiency in safety databases and regulatory submission tools are mandatory. This remote position requires self-motivation, excellent time management, and the ability to work effectively independently.
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8
Lead Pharmacovigilance Scientist - Global Safety Monitoring
751001 Bhubaneswar, Orissa
₹120000 Annually
WhatJobs
Posted 18 days ago
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Job Description
Our client is a leading global pharmaceutical company seeking a highly experienced Lead Pharmacovigilance Scientist to join our expanding remote-first team. This critical role will oversee the safety monitoring of our diverse drug portfolio, ensuring regulatory compliance and patient safety worldwide. You will be responsible for the end-to-end management of adverse event reporting, signal detection, and risk assessment. This position offers the flexibility of a fully remote work arrangement, allowing you to contribute from anywhere while collaborating with international teams.
Responsibilities:
Qualifications:
Responsibilities:
- Lead and manage the global pharmacovigilance operations, including the collection, assessment, and reporting of adverse event data.
- Develop and implement robust safety monitoring strategies for assigned pharmaceutical products.
- Conduct comprehensive signal detection activities to identify potential safety trends and emerging risks.
- Prepare and review Periodic Safety Update Reports (PSURs) and other regulatory safety submissions.
- Collaborate with internal stakeholders (e.g., Regulatory Affairs, Clinical Development, Medical Affairs) and external partners to ensure consistent safety messaging.
- Maintain up-to-date knowledge of global regulatory requirements and guidelines related to pharmacovigilance.
- Mentor and guide junior pharmacovigilance staff, fostering a culture of continuous improvement and scientific rigor.
- Participate in cross-functional teams for new product development, providing safety input from pre-clinical to post-marketing phases.
- Contribute to the development and maintenance of pharmacovigilance SOPs and training materials.
- Manage relationships with third-party vendors involved in safety data collection and processing.
Qualifications:
- M.D., Pharm.D., Ph.D., or Master's degree in a relevant life science or healthcare field.
- Minimum of 8 years of progressive experience in pharmacovigilance and drug safety within the pharmaceutical industry.
- In-depth understanding of global regulatory pharmacovigilance requirements (e.g., FDA, EMA, ICH).
- Proven experience in signal detection, risk management, and aggregate reporting.
- Excellent analytical, critical thinking, and problem-solving skills.
- Demonstrated leadership capabilities with experience managing teams and projects.
- Exceptional written and verbal communication skills, with the ability to communicate complex scientific information clearly.
- Proficiency with safety databases and data analysis tools.
- Ability to work effectively in a remote, cross-cultural team environment.
- Experience with vaccine pharmacovigilance is a plus.
This advertiser has chosen not to accept applicants from your region.
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