Drug Safety Associate

3 weeks ago


Bangalore Urban, India GSS Pharma Pvt.Ltd Full time

Company Description

GSS Pharma Pvt.Ltd is an emerging pharmaceutical company based in Bangalore, India. With a focus on manufacturing and exporting finished formulations, GSS Pharma caters to a diversified pharmaceutical market with over 400 formulations in therapeutic segments, including psychotropic and controlled substances. Committed to delivering quality products and services, GSS Pharma has a professionally managed team of passionate individuals. The company also offers Pharmacovigilance services to pharmaceutical companies worldwide.


Role Description

This is a full-time on-site role for a Drug Safety Associate at GSS Pharma Pvt.Ltd in Bangalore Urban. The Drug Safety Associate will be responsible for tasks related to Pharmacovigilance, including assistance to QPPV, global literature monitoring, data entry and quality review, signal detection and evaluation, and preparation of regulatory documents.


Detailed knowledge about current global pharmacovigilance guidelines and procedures

•            Prioritize the cases according to day zero and seriousness, and ensure the cases are completed according to the timelines mentioned in client SOP.

•            Verifies the data captured by case registration/import associate for accuracy.

•            Performs duplicate check during case processing to identify any inconsistency as applicable.

•            Downloading literature reports, line listing, and case processing of the same.

•            Accountable for reviewing and assessing the validity of literature abstracts and articles with further processing onto the safety database if required.

•            Downloading Individual Case Study Reports (ICSR), line listing, and case processing of the same.

•            MedDRA coding.

•            Vigilance on Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and updating the same.

•            Worldwide scientific Literature Management which includes screening and processing of Literature reports.

•            Assuring compliance with the use of database through the reference of latest SOPs and relevant manuals.

•            Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive workflow management.

•            Representing Drug Safety in regulatory and internal inspections and audits as required.

 


Qualifications

  • Narrative, Medical Coding, and Pharmacy skills
  • Doctor in Pharmacy (Pharm D)
  • Excellent attention to detail
  • Knowledge of pharmacovigilance regulations and requirements
  • Strong written and verbal communication skills
  • Experience in Pharmacovigilance or related role is a plus


  • Bangalore, India AstraZeneca Full time

    Job Title: Associate Director, Clinical Trial Safety Career Level - E Introduction to Role: Join us at AstraZeneca's Biopharmaceuticals R&D department as an Associate Director, Clinical Trial Safety. In this role, you will be part of the Trial Safety Review Center (TRISARC), a team dedicated to ensuring the accuracy and completeness of medical data...


  • bangalore, India AstraZeneca Full time

    Job Title: Associate Director, Clinical Trial Safety Career Level - E Introduction to Role: Join us at AstraZeneca's Biopharmaceuticals R&D department as an Associate Director, Clinical Trial Safety. In this role, you will be part of the Trial Safety Review Center (TRISARC), a team dedicated to ensuring the accuracy and completeness of medical...


  • bangalore, India Fortrea 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...


  • bangalore, 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...


  • bangalore, India Seven Consultancy Full time

    JOB DETAILS 1. Participate in CGMP, Safety and on the job trainings as per schedule2. Responsible for executing the batch production records as per approved BPR and ensure that completeness of the document3. Performing all the production activities as per the training given4. Responsible to ensure that all production deviations are reported in the...


  • bangalore, 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...

  • Safety Writer

    1 month ago


    bangalore, India Lifelancer Full time

    Job Description Summarized Purpose: Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not...


  • bangalore, India Novo Nordisk AS Full time

    Department :  Global Safety. 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 the...


  • bangalore, India Syngene Full time

    JOB DESCRIPTION Job Title: Research Associate/Sr. Research Associate Job Location: Bengaluru Reporting to: Principal Investigator Job Grade: 9-I/II At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and...


  • bangalore, India Labcorp Drug Development Full time

    Our Data Reconciliation Team is looking to hire Associate Data Analyst to support the team. The Associate Data Analyst (ADA) will provide support to the Data Analyst team to ensure the overall process ofresolving the discrepant data between client (Sponsor/CRO/lnvestigator) and our database. The ADA will understand the needs of the client, analyzing their...


  • bangalore, India Novo Nordisk Full time

        Department :  Global Safety.   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 the...


  • bangalore, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Primary Responsibilities Apply clinical judgement, critical thinking, and regulatory knowledge to the management of adverse event data within GPS systems to ensure data integrity, consistency, and compliance. Continuously expand knowledge of Lilly compounds...


  • bangalore, India Labcorp Drug Development Full time

    Description Sr. Associate UX Designer We are seeking a Senior Associate UX Designer to work alongside the design, development and product teams to deliver delightful user experiences that drive measurable business impact. Principal Responsibilities: Design modern and efficient single page applications that address unique user...


  • bangalore, India 2coms Full time

    Prioritize case processing activities for ICSRs inaccordance with project guidelines, Regulatory due date and TAT SLAs and KPIs. • Processing and evaluation ofIndividual Case Safety Reports • Consistent data entry and processing from source documents, adhering totimelines and quality. • Confirm accurate and co...


  • bangalore, India Novo Nordisk AS Full time

    Department  : Global Safety - Global Business Services (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...


  • Bangalore, India Quest Global Engineering Solutions Private Limited Full time

    Roles & Responsibilities : - Create and implement the functional safety strategy and roadmap in accordance with the ISO 26262 and other applicable vehicle safety requirements. - Lead and facilitate the creation and maintenance of safety plans, safety cases, and safety analyses.- Conduct safety analysis tasks in coordination with the global team and the...


  • bangalore, India Novo Nordisk AS Full time

    Department – Centralised Monitoring Unit (CMU)- Bangalore 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...

  • E&M Safety Officer

    23 hours ago


    bangalore, India Syngene Full time

    JOB DESCRIPTION Job Title: E&M Safety Officer Job Location: Bangalore  Department: E&M  About Syngene Incorporated in 1993, Syngene International has grown to become a major player in the contract research and manufacturing services domain. Syngene supports R&D programs from lead generation to clinical supplies. Our...

  • Associate Director

    2 months ago


    bangalore, India Baxter Full time

    Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the...


  • bangalore, India ADCI - Karnataka Full time

    Prime Video is changing the way people watch movies and TV shows, with millions of titles available on-demand on Kindle, Fire TV, mobile devices, game consoles, Internet-connected TVs, and Blu-ray players. Are you excited about launching content on Prime Video and holding key impact on helping our business scale? We are seeking an innovative and think big...