Drug Safety Associate

1 week ago


Bengaluru, Karnataka, India GSS Pharma Pvt Full time

About the Role of Drug Safety Associate at GSS Pharma Pvt.Ltd

GSS Pharma Pvt.Ltd, a leading pharmaceutical company located in Bangalore, India, specializes in manufacturing and exporting finished formulations across various therapeutic segments, including psychotropic and controlled substances. The company is dedicated to providing high-quality products and services and is supported by a team of dedicated professionals. Additionally, GSS Pharma offers Pharmacovigilance services to pharmaceutical companies globally.

Responsibilities of Drug Safety Associate:

  • Thorough understanding of current global pharmacovigilance guidelines and procedures
  • Prioritize cases based on urgency and severity, ensuring timely completion as per client SOP
  • Verify data accuracy captured by case registration/import associate
  • Perform duplicate checks during case processing to identify inconsistencies
  • Download literature reports, line listings, and process cases accordingly
  • Review and assess the validity of literature abstracts and articles before database entry
  • Download and process Individual Case Study Reports (ICSR)
  • Conduct MedDRA coding
  • Stay updated on Pharmacovigilance Risk Assessment Committee (PRAC) recommendations
  • Manage worldwide scientific literature including screening and processing reports
  • Ensure compliance with database usage through the latest SOPs and manuals
  • Maintain compliance with regulatory timelines through proactive workflow management
  • Represent Drug Safety in regulatory and internal inspections and audits

Qualifications:

  • Proficiency in Narrative, Medical Coding, and Pharmacy skills
  • Holder of a Doctorate in Pharmacy (Pharm D)
  • High attention to detail
  • Familiarity with pharmacovigilance regulations and requirements
  • Excellent written and verbal communication abilities
  • Experience in Pharmacovigilance or related roles is advantageous


  • Bengaluru, Karnataka, India Merck KGaA Darmstadt Germany Full time

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...


  • Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Department : Global Safety GBS (GS - GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might...


  • Bengaluru, Karnataka, India Novo Nordisk Full time

    Department: Global Safety GBS (GS - GBS). Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have...


  • Bengaluru, Karnataka, India Merck KGaA Darmstadt Germany Full time

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...


  • Bengaluru, Karnataka, India Oracle Full time

    Job Description`Overview of the OrganizationOracle Life Sciences GIU (LSGIU) provides industry leading solution to Life Sciences organizations including pharmaceutical companies, CROs (Contract research Organizations), Academic research and Healthcare providers that include care providers, IDN (integrated delivery networks), public regional/national...

  • Drug Safety Lead

    1 week ago


    Bengaluru, Karnataka, India Indegene Full time

    We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation,...

  • Drug Safety Lead

    1 week ago


    Bengaluru, Karnataka, India Indegene Full time

    We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation,...


  • Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Bengaluru, Karnataka, India VedTechBio Full time

    Job Title: Scientific and Medical Expert Advisor at Life Sciences CompanyResponsibilities:Assessing the standard of care in therapeutic areas to quantify unmet medical needs and assess the potential value of novel treatment ideas.Conducting efficacy and safety assessments for diverse diseases and evaluating different approaches to treatment.Evaluating...

  • Safety Associate

    1 week ago


    Bengaluru, Karnataka, India IQVIA Full time

    Job OverviewReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team...


  • Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Department – Clinical Reporting GBS Are you detail-oriented and experienced in compiling and publishing clinical and safety documents? Are you passionate about ensuring the quality and compliance of regulatory submissions? We are looking for an Associate Clinical Safety Publisher to join our team at Novo Nordisk. If you are ready for a new challenge...


  • Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

    As a top global contract research organization (CRO) with a strong focus on scientific rigor and extensive experience in clinical development, Fortrea offers pharmaceutical, biotechnology, and medical device clients a diverse range of solutions in clinical development, patient access, and technology across 20+ therapeutic areas. With a workforce of over...


  • Bengaluru, Karnataka, India Novo Nordisk Full time

    Department - GS GBS Safety Medical WritingThe PositionAs a Safety Medical Writer (SMW), you will plan, drive and co-ordinate preparation of safety documents to ensure submission according to agreed timelines. You will prepare aggregate safety reports, clinical risk management plans and responses to questions from health authorities in collaboration with...


  • Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Bengaluru, Karnataka, India Novo Nordisk Full time

    Department – Clinical Reporting GBS Are you detail-oriented and experienced in compiling and publishing clinical and safety documents? Are you passionate about ensuring the quality and compliance of regulatory submissions? We are looking for an Associate Clinical Safety Publisher to join our team at Novo Nordisk. If you are ready for a new challenge and...


  • Bengaluru, Karnataka, India Thermo Fisher Scientific Full time

    We are vital links between an idea for a new medicine and the people who need it.We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...


  • Bengaluru, Karnataka, India Seven Consultancy Full time

    JOB DETAILS 1. Participate in CGMP, Safety and on the job trainings as per scheduleResponsible for executing the batch production records as per approved BPR and ensure that completeness of the documentPerforming all the production activities as per the training givenResponsible to ensure that all production deviations are reported in the BPR and inform...


  • Bengaluru, Karnataka, India Novo Nordisk Full time

    Associate Safety Operations Advisor.Department - GS GBS SOA, EA & SS and QPPV support.Location - Bengaluru, India.About the DepartmentGlobal Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for global handling and reporting of adverse events...


  • Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Associate Director, Clinical Trial SafetyCareer Level - EIntroduction to Role:Join the AstraZeneca's Biopharmaceuticals R&D team as an Associate Director, Clinical Trial Safety. Your main focus will be ensuring the accuracy and completeness of medical data in our clinical trials. You will manage the TRISARC team, collaborate with Study Physicians,...