620 Pharmacovigilance jobs in India
Pharmacovigilance Specialist
Posted 14 days ago
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Pharmacovigilance Specialist
Posted 17 days ago
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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.
Pharmacovigilance QA Auditor
Posted 3 days ago
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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.
Lead Pharmacovigilance Scientist
Posted today
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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.
Senior Pharmacovigilance Scientist
Posted 1 day ago
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Location: Kolkata, West Bengal, IN
Senior Pharmacovigilance Specialist
Posted 1 day ago
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Job Description
- 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.
Senior Pharmacovigilance Associate
Posted 1 day ago
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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.
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Senior Pharmacovigilance Scientist
Posted 5 days ago
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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.
Senior Pharmacovigilance Specialist
Posted 6 days ago
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Job Description
- 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.
- 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).
Senior Pharmacovigilance Specialist
Posted 7 days ago
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Explore pharmacovigilance jobs, which are critical in monitoring drug safety and efficacy. These roles involve collecting, assessing, and reporting adverse drug reactions to regulatory authorities and pharmaceutical companies. Professionals in this field play a key role in ensuring patient safety and compliance with global pharmacovigilance regulations. Job opportunities can be found within pharmaceutical companies, contract research organizations (CROs), and regulatory agencies.