483 Pharmacovigilance jobs in India

Pharmacovigilance Specialist

411001 Pune, Maharashtra ₹65000 month WhatJobs

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full-time
Our client, a leading global pharmaceutical company, is actively recruiting a diligent and experienced Pharmacovigilance Specialist to join their fully remote team. This crucial role involves the monitoring, detection, assessment, and prevention of adverse effects of pharmaceutical products. You will play a key part in ensuring regulatory compliance and patient safety by meticulously managing adverse event data, conducting signal detection, and contributing to safety reporting.

Key Responsibilities:
  • Collect, review, and process adverse event reports from various sources (e.g., clinical trials, post-marketing surveillance, literature).
  • Enter and manage adverse event data in the company's safety database, ensuring accuracy and completeness.
  • Assess the seriousness and causality of reported adverse events according to established guidelines.
  • Perform signal detection activities to identify potential new safety concerns associated with pharmaceutical products.
  • Contribute to the preparation and submission of periodic safety update reports (PSURs), development safety update reports (DSURs), and other regulatory safety documents.
  • Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Operations) and external partners to gather necessary information.
  • Ensure compliance with global pharmacovigilance regulations and company policies.
  • Participate in internal and external audits and inspections related to pharmacovigilance activities.
  • Stay updated on relevant pharmacovigilance guidelines, regulations, and best practices.
  • Contribute to the development and improvement of pharmacovigilance processes and procedures.

Qualifications:
  • Bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare field. A Master's degree is a plus.
  • Minimum of 3 years of experience in pharmacovigilance, drug safety, or a related pharmaceutical role.
  • Thorough understanding of global pharmacovigilance regulations (e.g., FDA, EMA guidelines).
  • Experience with safety database systems (e.g., Argus Safety, ArisG) and adverse event reporting.
  • Strong medical terminology knowledge and ability to assess adverse event reports.
  • Excellent analytical, critical thinking, and problem-solving skills.
  • Meticulous attention to detail and strong organizational skills.
  • Effective written and verbal communication skills, particularly for technical and regulatory reporting.
  • Ability to work independently and manage workload efficiently in a remote setting.
  • Proficiency in standard office software (Microsoft Office Suite).

This remote position offers a competitive salary and benefits package, along with the opportunity to contribute to ensuring the safety of medicines worldwide. Join our client's dedicated pharmacovigilance team and make a significant impact on public health.
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Pharmacovigilance Officer

Vadodara, Gujarat Shaily Innovations Ltd.

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Pharmacovigilance Officer to handle Pharmacovigilance cases Submit the Pharmacovigilance cases to the health authority Maintain Pharmacovigilance Data Powered by JazzHR

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Pharmacovigilance Manager

Mumbai, Maharashtra Galderma

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Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

  • Function Duties and Responsibilities

    Implements and maintains the local vigilance system and its quality system, including management of local Standard Operating Procedures (SOPs) and related indicators, audits and inspection readiness, and record management of relevant documentation.

  • Manages safety information received from any sources including their receipt, follow-up, reconciliation, documentation, and submission to local authorities in accordance with local and global SOPs, third-party agreements and regulatory requirements.
  • Conducts screening of local literature and ensures adequate monitoring of digital media and social networks to identify safety reports involving Galderma products.
  • Contributes to the preparation and submission of aggregate safety reports to local authorities.
  • Contributes to the management of safety signals and escalates any trends that may impact the benefit-risk profile of a Galderma product.
  • Contributes to the management of safety risks and implements local Risk Management Plans (RMPs) where required.
  • Contributes to the conduct and oversight of post-marketing studies sponsored and managed by Galderma India, i.e., non-interventional studies, interventional studies, post-authorization safety studies, investigator-initiated trials, patient support programs, drug utilization studies, market research, etc.
  • Implements and maintains Safety Data Exchange Agreements (SDEAs) with local Vigilance Agreement Partners (VAPs).
  • Establishes and delivers vigilance training to affiliate and local VAP employees, and maintenance of training records.
  • Organizes the regulatory intelligence and business continuity of vigilance activities.
  • Establishes and maintains relationships with interacting departments and organizations, i.e., local authorities, local VAPs, affiliate Business Units, etc.
  • Contributes to the continuous oversight of the European Union (EU) Qualified Person Responsible for Pharmacovigilance (QPPV) by updating the dedicated tool with the required vigilance Key Performance Indicators (KPIs) relating to the local vigilance system.
  • Notifies the JPAC Head of PV and Global PV Compliance of any announcement of inspection by the local authorities or audit by a local VAP; leads local vigilance inspection and audits activities; and is responsible for the development, implementation, follow-up, and resolution of Corrective and Preventive Action (CAPA) plans.
  • Participates in Global PV and JPAC PV meetings.
  • Supports any ad-hoc duties as assigned from time to time.
  • Function

    Duties and

    Responsibilities

    Others

  • Foster and maintain good cross-functional working relationships with other departments.
  • Represent Galderma India in the relevant committees of the professional/industry associations, if necessary.
  • Profile

    Requirements

    Education and Training

    Master’s degree in pharmacy, Life Sciences or equivalent related field, a licensed Pharmacist is preferred.

    Work Experience

  • Minimum 6 years of pharmacovigilance, medical device vigilance and/or cosmetovigilance operations experience in the pharmaceutical, biotechnology or consumer healthcare industry with demonstrated knowledge of local and global vigilance regulations, submission requirements and management of local and global authority requests.
  • Language

    Proficiency in written and spoken business-level English.

    Required pre-requisites skills/experience for this position

  • Good analytical skills and attention to detail with the capability to appropriately define issues, questions and data.
  • Good project management, problem-solving, time management, negotiation and interpersonal skills.
  • Self-starter with the ability to work both independently or as part of a team as required.
  • Commitment to continuous improvement in functional processes and performance.
  • Good team player, assisting others with workload peaks and management of challenging situations.
  • Proactively contributes to a positive team attitude and highly productive work environment.
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    Analyst - Pharmacovigilance

    Bengaluru, Karnataka Elanco

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    At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
    At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.
    We believe that diversity is the driving force behind innovation, creativity, and overall business success.
    Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! To be added Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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    Analyst - Pharmacovigilance

    Bengaluru, Karnataka Elanco

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    At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! To be added Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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    Analyst - Pharmacovigilance

    Bengaluru, Karnataka Elanco

    Posted today

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    Job Description

    At Elanco (NYSE: ELAN) – it all starts with animals!

    As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

    At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

    Making animals’ lives better makes life better – join our team today!

    To be added

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    Data Officers (Pharmacovigilance)

    ProductLife Group

    Posted 20 days ago

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    ProductLife Group is looking for Data Officers (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub.


    You will be required to work Easter USA Time Zone (6.30pm to 2.30 am IST)


    Responsibilities:

    • To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as required
    • Management of the generic or client specific email boxes as appropriate.
    • Registration, triage, assignment and coordination for the processing of vigilance cases
    • Follow-up requests with local reporters
    • Responding to queries from client and reporters
    • To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients
    • Support/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as needed
    • To participate in audits / inspections and resulting action plan


    Education and Experience:

    • Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience
    • 2+ years’ experience in pharmacovigilance working for service providers performing data entry and QC of cases
    • Previous experience working to deadlines.
    • Client communications
    • Knowledge of US and EU PV regulations
    • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
    • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment


    Skills:

    • Excellent organizational and interpersonal skills
    • Ability to work well within a team
    • Excellent time management skills
    • Accountability and autonomy with assigned tasks
    • Process orientated with good attention to detail
    • Effective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.
    • Flexibility and adaptability to handle a dynamic workload
    • Works well under pressure and working to timelines
    • Safety database experience
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    Medical Advisor (Pharmacovigilance)

    ProductLife Group

    Posted 20 days ago

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    We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety .


    Clinical Phase:

    • Lead as a medical monitor/Medical expert
    • Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and provide support to sites regarding protocol or possible drug interactions is essential.
    • Review and provide feedback on study protocols as needed.
    • Deliver therapeutic area training for all case processing team.
    • May require 24/7 availability depending on the client needs for possible queries or protocol deviations resulting in potential harm to patients.
    • Drafting medical monitoring plans (MMP) and ensuring compliance.
    • Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions (like dose adjustments or trial discontinuation).
    • Make assessments on SUSAR reportability.
    • Perform the review and interpret clinical data, ensure protocol compliance and draft monthly reports for the clients (with presentation at periodic meetings if required).
    • Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.


    Post-Marketing (Pharmacovigilance):

    • Support in maintenance of medical platform including SOPs, manual and documents.
    • Lead and support the medical reviewers
    • Interaction with the clients medical team and clinical team
    • Act as an main responsible person at PLG for clients concerns and escalation
    • Medical review of the ICSRs (e.g., Spontaneous, literature)
    • Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
    • Mentor junior medical reviewers and perform additional review of cases to ensure competency.
    • Provide feedback and ongoing workshops to develop the medical reviewers.
    • Participate in audits and inspections as required
    • Ensure understanding of client needs, conventions and ensure expectations are met and exceeded
    • Training and mentoring other team members


    Required education : MBBS, or MD (Doctor of Medicine)


    Required experience :

    • Experience in leading medical review teams
    • Client communications
    • Safety Database experience
    • Minimum 10 years experience working for service providers or pharmaceutical company
    • At least 5-7 years of experience as a Medical Monitor or clinical phase


    Required technical skills:

    • Microsoft package
    • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
    • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
    • Working knowledge of EDC systems
    • Good Medical knowledge and Pharmacology understanding
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    Data officers (pharmacovigilance)

    Bengaluru, Karnataka ProductLife Group

    Posted today

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    Product Life Group is looking for Data Officers (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub.You will be required to work Easter USA Time Zone (6.30pm to 2.30 am IST)Responsibilities:To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as requiredManagement of the generic or client specific email boxes as appropriate.Registration, triage, assignment and coordination for the processing of vigilance casesFollow-up requests with local reportersResponding to queries from client and reportersTo carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG ClientsSupport/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as neededTo participate in audits / inspections and resulting action planEducation and Experience:Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience2+ years’ experience in pharmacovigilance working for service providers performing data entry and QC of casesPrevious experience working to deadlines.Client communicationsKnowledge of US and EU PV regulationsPharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessmentSkills:Excellent organizational and interpersonal skillsAbility to work well within a teamExcellent time management skillsAccountability and autonomy with assigned tasksProcess orientated with good attention to detailEffective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.Flexibility and adaptability to handle a dynamic workloadWorks well under pressure and working to timelinesSafety database experience

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    Data officers (pharmacovigilance)

    Mangaluru, Karnataka ProductLife Group

    Posted today

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    Job Description

    Product Life Group is looking for Data Officers (Pharmacovigilance) to join our dynamic team to contribute to the activities performed in the Hub.You will be required to work Easter USA Time Zone (6.30pm to 2.30 am IST)Responsibilities:To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as requiredManagement of the generic or client specific email boxes as appropriate.Registration, triage, assignment and coordination for the processing of vigilance casesFollow-up requests with local reportersResponding to queries from client and reportersTo carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG ClientsSupport/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as neededTo participate in audits / inspections and resulting action planEducation and Experience:Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience2+ years’ experience in pharmacovigilance working for service providers performing data entry and QC of casesPrevious experience working to deadlines.Client communicationsKnowledge of US and EU PV regulationsPharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessmentSkills:Excellent organizational and interpersonal skillsAbility to work well within a teamExcellent time management skillsAccountability and autonomy with assigned tasksProcess orientated with good attention to detailEffective communications skills both written and verbal to be able to explain complex concepts and address queries from the team.Flexibility and adaptability to handle a dynamic workloadWorks well under pressure and working to timelinesSafety database experience

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