620 Pharmacovigilance jobs in India

Our client, a global pharmaceutical leader, is actively seeking a dedicated and detail-oriented Pharmacovigilance Specialist to join their expanding team on a fully remote basis. This critical role involves monitoring the safety of pharmaceutical products post-marketing, ensuring compliance with global regulatory requirements, and contributing to patient safety initiatives. You will be responsible for collecting, assessing, and reporting adverse event data, working independently from your home office. This position offers the flexibility and autonomy of a remote-first environment, supported by advanced digital collaboration tools.

Key Responsibilities:

• Receive, process, and evaluate adverse event reports from various sources (healthcare professionals, patients, literature, etc.).
• Ensure accurate and timely data entry into the pharmacovigilance database.
• Perform case assessment, including seriousness, causality, and expectedness determination.
• Prepare and submit regulatory safety reports (e.g., ICSRs, PSURs) to health authorities worldwide.
• Collaborate with internal departments (e.g., Regulatory Affairs, Medical Affairs, R&D) and external stakeholders to gather necessary information for case processing.
• Stay updated on global pharmacovigilance regulations, guidelines, and best practices.
• Participate in signal detection activities and contribute to risk management planning.
• Assist in the preparation and maintenance of aggregate safety databases and related documentation.
• Contribute to the development and improvement of pharmacovigilance processes and procedures.
• Maintain confidentiality and ensure compliance with data privacy regulations.

Qualifications:

• Bachelor's degree in Pharmacy, Medicine, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Thorough understanding of global pharmacovigilance regulations (e.g., FDA, EMA, ICH guidelines).
• Experience with adverse event case processing and reporting.
• Familiarity with pharmacovigilance databases and safety reporting systems.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently, manage multiple tasks, and meet strict deadlines in a remote setting.
• High level of accuracy and attention to detail.
• Proficiency in English is essential; additional language skills are a plus.

Embrace this opportunity to play a pivotal role in ensuring drug safety and making a tangible difference in public health, all within the comfort and convenience of a remote work arrangement.

**Title:**
Pharmacovigilance QA Auditor
**Business Unit:**
R&D Quality
**Job Grade**
Executive / G12A
**Location:**
Gurugram, H.R.
**Key Responsibilities**
At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**JOB DESCRIPTION :**
+ Assist in **developing global Pharmacovigilance system auditing program** and responsible for **conducting and reporting audits being a lead auditor/co-auditor** for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc., associated with Sun Pharma Pharmacovigilance operations.
+ Assist in **conducting and reporting audits** for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.
+ Management of **Internal Audit Observation Database (IAOD)** with the perspective of sharing audit reports, **CAPA reports** and observation of global impact with all internal regional PV sites across the globe and Global Pharmacovigilance.
+ To assure that **the CAPAs are adequately addressed and closed.**
+ **To review and close deviations** raised at global and regional levels in order to ensure adequacy of associated CAPA.
+ **Responsible for review of Pharmacovigilance SOPs** for completeness, clarity, and compliance to global/regional policies, and applicable regulatory regulations & guidelines.
+ To prepare and review departmental SOPs
+ To assist in monthly report preparation
+ Management training and records of GPvP-QA team through LMS
+ Support operations team during corporate audit/ external audits
+ Collaborate with cross-functional teams to ensure quality standards are met across all pharmacovigilance activities.
+ Lead the assessment, tracking of global actions and monitoring of identified actions as part of various corporate initiatives.
+ To perform any other responsibilities assigned with regards to the R&D Quality system.
+ Maintain documentation and records in accordance with quality and regulatory standards.
**Education and Experience:**
+ Post Graduate in Pharmacy (M. Pharma) OR BDS
+ Around 2 years of experience in Pharmacovigilance Quality Assurance **OR** 2 years experience in PSUR/Signal management
**Technical Competencies:**
+ Auditing skills
+ Attention to detail
**Behavioural Competencies / Soft Skills:**
+ Good spoken and written English
+ Liaising with different teams
**Travel Estimate**
Low
**Job Requirements**
**Educational Qualification**
**Post Graduate in Pharmacy (M. Pharma) OR BDS**
**Experience**
Around 2 years of experience in **Pharmacovigilance Quality Assurance OR** 2 years experience in **PSUR/Signal management**
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Our client, a leading pharmaceutical innovator, is seeking a highly experienced Lead Pharmacovigilance Scientist to join their dedicated safety surveillance team in Noida, Uttar Pradesh, IN . This critical role involves overseeing and enhancing the company's drug safety monitoring systems, ensuring compliance with global regulatory requirements, and contributing to the safe and effective use of pharmaceutical products. You will play a key role in managing adverse event data, conducting signal detection and risk assessment, and collaborating with cross-functional teams to mitigate potential safety concerns.
Key Responsibilities:

• Lead and manage pharmacovigilance operations, including case processing, safety database management, and regulatory reporting.
• Develop and implement pharmacovigilance strategies and procedures in alignment with global regulatory guidelines (e.g., ICH, FDA, EMA).
• Conduct robust signal detection and risk assessment activities, identifying potential safety issues and recommending appropriate actions.
• Prepare and review periodic safety update reports (PSURs), development safety update reports (DSURs), and other regulatory safety documents.
• Collaborate with clinical development, medical affairs, regulatory affairs, and quality assurance teams to ensure integrated safety management.
• Provide expert input on safety aspects during drug development, clinical trials, and post-marketing phases.
• Manage and mentor a team of pharmacovigilance professionals, fostering a culture of scientific rigor and operational excellence.
• Participate in regulatory inspections and audits, ensuring the company's pharmacovigilance system meets the highest standards.
• Contribute to the development and maintenance of safety risk management plans.
• Stay abreast of evolving regulatory requirements and scientific advancements in pharmacovigilance.

Qualifications:

• Advanced degree (MD, PhD, PharmD, MSc) in a life science, healthcare, or related discipline.
• Minimum of 10 years of experience in pharmacovigilance, with a significant portion in a leadership or lead role.
• Extensive knowledge of global pharmacovigilance regulations, guidelines, and best practices.
• Proven expertise in adverse event data analysis, signal detection, and risk management.
• Strong understanding of clinical trial processes and pharmaceutical product lifecycle.
• Excellent leadership, team management, and interpersonal skills.
• Exceptional written and verbal communication skills, with the ability to present complex data clearly.
• Experience with safety databases and pharmacovigilance software.
• Ability to work effectively in a hybrid work environment, balancing remote work with essential on-site collaboration.

This is an excellent opportunity for a seasoned pharmacovigilance expert to make a significant impact within a forward-thinking pharmaceutical organization.

Our client is seeking an experienced Senior Pharmacovigilance Scientist to join their dedicated safety surveillance team in Kolkata, West Bengal, IN . This role is integral to ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle. You will be responsible for the meticulous collection, assessment, and reporting of adverse event data, ensuring compliance with global regulatory requirements. Key responsibilities include performing case processing, signal detection, and risk assessment, as well as contributing to the preparation of periodic safety update reports (PSURs) and development safety update reports (DSURs). You will also engage with regulatory authorities, internal stakeholders, and healthcare professionals to communicate safety information effectively. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Pharmacology, Medicine, or a related life science discipline, coupled with a minimum of 5 years of hands-on experience in pharmacovigilance. A strong understanding of global regulatory guidelines (e.g., FDA, EMA) and ICH principles is mandatory. Proficiency in pharmacovigilance databases and reporting systems is essential. Excellent analytical, critical thinking, and written/verbal communication skills are required to effectively interpret complex data and communicate findings. You should be highly organized, detail-oriented, and capable of working under pressure to meet strict deadlines. The ability to collaborate effectively within a multidisciplinary team is crucial. This position requires a commitment to maintaining the highest standards of patient safety and contributing to public health. We are looking for a proactive and dedicated professional who can independently manage workload and mentor junior team members. Your expertise will be vital in safeguarding our product portfolio and upholding our commitment to patient well-being. The role involves significant data analysis and interpretation, requiring a strong scientific acumen and attention to detail. You will be a key contributor to risk management strategies and benefit-risk assessments for our pharmaceutical products. Opportunities for professional development and continuous learning in the field of drug safety are provided.
Location: Kolkata, West Bengal, IN

Our client, a leading pharmaceutical organization, is seeking a highly diligent and experienced Senior Pharmacovigilance Specialist to join their safety surveillance team. This critical role will ensure the ongoing monitoring of drug safety and the prompt reporting of adverse events. You will be responsible for evaluating safety data, identifying potential safety signals, and contributing to risk management strategies. The ideal candidate will have a strong understanding of pharmacovigilance principles, regulatory requirements, and data analysis techniques. You will collaborate with internal departments and external healthcare professionals to maintain the highest standards of patient safety. Responsibilities include:

• Receiving, assessing, and processing adverse event reports from various sources.
• Conducting detailed case reviews and determining causality assessments.
• Identifying potential safety signals through trend analysis and signal detection activities.
• Preparing aggregate safety reports, such as Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
• Ensuring compliance with global regulatory requirements for pharmacovigilance reporting (e.g., FDA, EMA).
• Contributing to the development and implementation of risk management plans (RMPs).
• Collaborating with clinical development, medical affairs, and regulatory affairs teams.
• Responding to safety inquiries from regulatory authorities and internal stakeholders.
• Participating in pharmacovigilance audits and inspections.
• Staying current with evolving pharmacovigilance regulations and best practices.
• Training and mentoring junior pharmacovigilance staff.

The successful candidate will possess a Bachelor's or Master's degree in Pharmacy, Medicine, Nursing, or a related life science field. A minimum of 5-7 years of direct experience in pharmacovigilance is required. Demonstrated experience with adverse event reporting systems (e.g., Argus Safety, ArisG) and knowledge of global regulatory guidelines are essential. Strong analytical skills, meticulous attention to detail, and excellent written and verbal communication abilities are crucial. This is an on-site position located in Bhubaneswar, Odisha, IN .

Our client is a prominent pharmaceutical company committed to patient safety and global health, and they are seeking an experienced Senior Pharmacovigilance Associate. This role is based in Hyderabad, Telangana, IN , and requires a diligent individual with a thorough understanding of adverse event reporting and drug safety regulations. You will be responsible for managing and processing safety data, ensuring compliance with regulatory requirements, and contributing to the overall safety profile of our pharmaceutical products. Your duties will include the accurate and timely collection, assessment, and reporting of adverse event cases from various sources. You will conduct thorough case investigations, prepare regulatory reports (e.g., DSURs, PBRERs), and manage safety databases. A key aspect of this role involves staying updated on evolving global pharmacovigilance guidelines and regulations and ensuring that our internal processes are aligned. You will also collaborate with internal teams, including Regulatory Affairs, Medical Affairs, and Clinical Development, as well as external stakeholders, such as healthcare professionals and regulatory agencies. The ideal candidate will possess strong analytical and critical thinking skills, with an exceptional attention to detail. Experience with pharmacovigilance databases and safety reporting systems is essential. Excellent written and verbal communication skills are required for clear and concise reporting and correspondence. We are looking for an individual who is committed to upholding the highest standards of patient safety and drug vigilance. This role offers a challenging and rewarding opportunity to contribute to a vital aspect of pharmaceutical development and ensure the safe use of medicines.

Responsibilities:

• Manage and process adverse event reports from multiple sources.
• Conduct comprehensive safety data assessment and reconciliation.
• Ensure timely and accurate submission of safety reports to regulatory authorities.
• Maintain and update pharmacovigilance databases.
• Collaborate with cross-functional teams on drug safety matters.
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs) and DSURs.
• Stay abreast of global pharmacovigilance regulations and guidelines.
• Participate in internal and external audits and inspections.
• Communicate safety information to healthcare professionals and other stakeholders.
• Contribute to risk management planning and signal detection activities.

Qualifications:

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, or a related healthcare field.
• Significant experience in pharmacovigilance or drug safety.
• In-depth knowledge of global pharmacovigilance regulations (e.g., ICH, FDA, EMA guidelines).
• Proficiency with pharmacovigilance databases and safety reporting software.
• Strong analytical, critical thinking, and problem-solving abilities.
• Excellent written and verbal communication skills.
• Meticulous attention to detail and accuracy.
• Ability to work effectively in a team and manage multiple tasks under pressure.
• Experience in signal detection and risk management is desirable.
• Certification in pharmacovigilance is a plus.

Our client, a leading pharmaceutical company, is seeking a highly qualified and dedicated Senior Pharmacovigilance Scientist to join their esteemed team in Vijayawada, Andhra Pradesh . This critical role involves the comprehensive surveillance of drug safety, ensuring the protection of public health by identifying, assessing, and reporting adverse events associated with pharmaceutical products. You will be instrumental in conducting signal detection activities, performing risk-benefit assessments, and contributing to the development of robust safety strategies throughout the product lifecycle. This position requires a deep understanding of regulatory requirements (e.g., ICH guidelines, local regulations), strong analytical skills, and the ability to interpret complex safety data. The ideal candidate will have extensive experience in pharmacovigilance, including case processing, aggregate data analysis, and regulatory reporting. You will collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure integrated safety management. This role also involves contributing to the preparation of periodic safety update reports (PSURs), development safety update reports (DSURs), and other regulatory submissions. If you are a meticulous scientist with a passion for drug safety and possess excellent scientific writing and communication skills, we encourage you to apply. This is a vital role contributing to the safe and effective use of medicines. The position is based in our Vijayawada facility.

Key Responsibilities:

• Monitor and evaluate the safety profiles of pharmaceutical products.
• Conduct signal detection and perform risk-benefit assessments.
• Manage and analyze adverse event data from various sources.
• Prepare and review Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
• Ensure compliance with global pharmacovigilance regulations and guidelines.
• Collaborate with clinical, regulatory, and medical affairs teams on safety-related matters.
• Contribute to the development of safety data exchange agreements (SDEAs).
• Investigate safety inquiries and prepare responses for regulatory authorities.
• Participate in audits and inspections related to pharmacovigilance activities.
• Provide expert input on safety aspects of clinical trial protocols and study reports.

Qualifications:

• Doctorate in Pharmacy (Pharm.D.), Medicine (MD), or a related life science degree.
• Minimum of 5-7 years of progressive experience in pharmacovigilance within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH E2B, E2C, E2D).
• Proven experience in adverse event case processing, signal detection, and risk management.
• Strong scientific writing and communication skills.
• Excellent analytical and critical thinking abilities.
• Ability to work independently and collaboratively in a team environment.
• Experience with pharmacovigilance databases and safety reporting systems.

Our client, a prominent pharmaceutical organization, is seeking a dedicated and experienced Senior Pharmacovigilance Specialist to join their safety surveillance team. This critical role ensures the ongoing safety monitoring of pharmaceutical products by collecting, assessing, and reporting adverse event data. The ideal candidate will possess a thorough understanding of pharmacovigilance principles, regulatory requirements (e.g., GVP, FDA guidelines), and case processing. This is a hybrid position, offering a blend of remote work and regular onsite collaboration to foster team synergy and strategic alignment. You will be instrumental in maintaining compliance, contributing to safety reports, and supporting regulatory submissions. Responsibilities include:

• Processing and assessing adverse event reports from various sources.
• Ensuring accurate and timely data entry into safety databases.
• Evaluating case narratives and identifying missing information.
• Performing literature searches for potential safety signals.
• Preparing and submitting regulatory reports (e.g., ICSRs, SUSARs) to health authorities.
• Contributing to the development and maintenance of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Interacting with regulatory authorities and external stakeholders regarding safety matters.
• Ensuring compliance with global pharmacovigilance regulations and internal SOPs.
• Participating in safety risk assessments and benefit-risk evaluations.
• Collaborating with clinical development, regulatory affairs, and medical affairs teams.
• Providing training and guidance to junior staff and other departments on pharmacovigilance procedures.

Qualifications:

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Medicine, or a related field.
• Minimum of 6 years of experience in pharmacovigilance or drug safety.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Experience with safety databases (e.g., Argus, ARISg) and case processing.
• Strong analytical and critical thinking skills.
• Excellent written and verbal communication abilities.
• Ability to work independently and as part of a team in a hybrid work environment.
• Meticulous attention to detail and strong organizational skills.
• Familiarity with medical terminology and coding conventions (e.g., MedDRA, WHODrug).

This hybrid role, with an office presence in **Bhopal, Madhya Pradesh, IN**, offers a competitive salary and benefits package for a qualified professional committed to ensuring patient safety.

Our client, a prominent pharmaceutical firm, is actively recruiting a Senior Pharmacovigilance Specialist for a fully remote position. This role is integral to ensuring the safety and efficacy of pharmaceutical products by meticulously monitoring, collecting, assessing, and reporting adverse events. The Senior Specialist will play a crucial part in maintaining regulatory compliance and upholding the highest standards of patient safety across the product lifecycle. Responsibilities encompass detailed case processing, including data entry, causality assessment, and narrative writing for individual adverse event reports. You will conduct signal detection activities, analyze safety data trends, and contribute to the preparation of aggregate safety reports, such as Periodic Safety Update Reports (PSURs) and Development Core Safety Information (DCSI). This position requires a comprehensive understanding of global pharmacovigilance regulations (e.g., FDA, EMA) and reporting requirements. You will liaise with internal departments, including regulatory affairs, medical affairs, and clinical operations, as well as external stakeholders such as healthcare professionals and regulatory authorities, to gather necessary safety information. The Senior Specialist will also be involved in developing and updating pharmacovigilance procedures and work instructions, ensuring compliance and operational efficiency. A critical aspect of this role is contributing to Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). The ideal candidate will possess strong analytical and critical thinking skills, with exceptional attention to detail and accuracy in data handling and reporting. Excellent written and verbal communication skills are essential, particularly for authoring safety narratives and communicating complex safety information. This remote role demands self-discipline, excellent time management, and the ability to work independently while collaborating effectively with a geographically dispersed team. If you are a dedicated pharmacovigilance professional committed to enhancing drug safety and seeking a flexible, remote work opportunity, we encourage you to apply.