Drug Safety Associate

2 weeks ago


India Novotech Asia Full time

Brief Position Description: Responsible for complete and accurate case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations.

**Minimum Qualifications & Experience**:

- A minimum of 1- 3years of industry and/or clinical experience with focus on safety related areas is required.
- ** Experience in Safety management plan (SMP) or risk management plan (RMP).**:

- ** Should have processed SUSAR cases.**:

- ** Should have done any ICSR unblinding.**:

- Thorough knowledge of medical terminology and ability to summaries medical information is required.
- Strong computer proficiency and ability to work in specific databases is required.
- Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred.

**Responsibilities**:
Manage project-specific activities which may include:

- Preparation of safety management plan, preparing safety DB configuration documents for each project; preparing slides for project kick off meetings.
- Case processing activities and drafting safety narratives including quality review to ensure accuracy and completeness, filing study documents in TMF.
- Manages unblinding procedures, where applicable, including creation of clear SOP; integration with information technology to ensure effective implementation of the unblinding SOP across safety database and IT systems.
- Monitoring of the safety mailbox.
- Conducting literature searches and monitor for adverse event reports as well as monitor post approval commitments.
- Participate in clinical study reconciliation activities, as requested by client.
- Liaison with medical monitors/ drug safety physicians, clients, and study teams as appropriate to clarify information required for case processing.
- Participation in inspection/ audit related activities; Assistance in preparation or implementation of corrective/ preventative actions relating to case processing.
- Timely submission of reports to regulatory agencies in accordance with applicable regulations and tracking the details of submissions for compliance.
- Preparation and submission of periodic safety reports such as **DSUR/PSUR**, per the study requirements.
- Support PV management in PV implementation activities.


  • Drug Safety Associate

    2 months ago


    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...


  • india Pharmavise Corporation Full time

    Job Description This is a remote position. From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our...


  • India Centella AI Therapeutics Full time

    Centella AI Therapeutics, a pioneering AI-powered drug discovery company, is seeking a passionate and inquisitive AI Drug Discovery intern to join our mission of revolutionizing healthcare through AI application. In this pivotal role, you'll delve into the world of AI and contribute to building AI models for their use in our cutting-edge drug development...


  • india VedTechBio Full time

    Responsibilities: Assess the standard of care within therapeutic areas of interest, quantifying unmet medical needs, and determining the potential medical value of proposed novel treatment ideas. Conduct efficacy and safety assessments and evaluate the scientific and medical merit of various approaches to treat diverse diseases. Assess competitive intensity...

  • Principal Safety

    2 weeks ago


    India Syneos Health Clinical Full time

    DescriptionPrincipal Safety & Pharmacovigilance SpecialistSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...

  • Technical Operations

    1 month ago


    india PSC Biotech Ltd Full time

    Job Description About PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • Safety Writer

    2 months ago


    india Thermo Fisher Scientific Full time

    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 limited to...


  • India DEKRA Process Safety Full time

    DEKRA India Pvt. Ltd. is a group company of DEKRA SE. DEKRA is one of the world’s leading professional safety firms, headquartered in Stuttgart, Germany. With over 45,000 employees in 50 countries, DEKRA has been active in the field of safety since 1925. DEKRA India Pvt. Ltd. with offices in Delhi, Mumbai, Pune and Hyderabad offers an exciting &...

  • Safety Writer

    2 weeks ago


    India Thermo Fisher Scientific Full time

    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 limited to delivery of...

  • associate manager

    2 weeks ago


    India Biocon Biologics Limited Full time

    Department Details Role Summary •Supports the signal management process ( set up process for periodic signal detection for company products, signal tracking, review meetings, signal detection overview reports, eRMR reports etc) for the assigned product (s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Data...

  • Principal Safety

    2 months ago


    India Syneos Health Clinical Full time

    **Description** **Principal Safety & Pharmacovigilance Specialist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide...

  • Safety Officer

    2 weeks ago


    India Mahindra & Mahindra Ltd Full time

    **Responsibilities & Key Deliverables** - Assist in the development of the Health, Safety and Environment systems to meet the requirements of OHSAS 18001 and ISO 14001.Assist with the Implementation of the HSE Strategy on the project. Identify and mitigate risks associated with work. Ensure Compliance with all statutory and client Safety regulations....


  • India Innovaderm Full time

    Medical Monitor Associate, Dermatologist (India) India CRO - Medical Affairs Full-time Reporting to the Team Lead Medical Monitoring, the Medical Affairs, the Medical Monitor Associate, Dermatologist , provides medical, scientific, and administrative support to the medical monitoring team in their study level, department level, and...

  • Associate Specialist

    2 weeks ago


    India ArisGlobal Full time

    ArisGlobal is a dynamic and growing global software company dedicated to serving the Life Sciences industry (pharmaceutical, biotechnology and medical device) in the management of their clinical trials, drug safety and regulatory information. Our global team – located in major corners of the world – includes some of the industry's leading authorities,...

  • Safety Officer

    2 weeks ago


    India Mahindra & Mahindra Ltd Full time

    Responsibilities & Key Deliverables Assist in the development of the Health, Safety and Environment systems to meet the requirements of OHSAS 18001 and ISO 14001.Assist with the Implementation of the HSE Strategy on the project. Identify and mitigate risks associated with work. Ensure Compliance with all statutory and client Safety regulations. Undertake...


  • india Innovaderm Full time

    Medical Monitor Associate, Dermatologist (India) India CRO - Medical Affairs Full-time Reporting to the Team Lead Medical Monitoring, the Medical Affairs, the Medical Monitor Associate, Dermatologist , provides medical, scientific, and administrative support to the medical monitoring team in their study level, department level, and...

  • Bioprocess Associate

    1 month ago


    india PSC Biotech Ltd Full time

    Job Description About PSC Biotech     Who we are?  PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management...


  • india PSC Biotech Ltd Full time

    Job Description About PSC Biotech     Who we are?  PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management...

  • Safety Engineer

    2 weeks ago


    India Performix Full time

    Job Description Job Description:Safety Engineer 100% onsite- The safety engineer will work Friday to Sunday, 6am-6pm. Work 36 hours.Duration anticipated up to 2 years, contract only.Local candidates only. First interview via Teams then second interview on-siteWhat will a candidate get to do in this position?Leads and promotes a SAFE First CultureAssures the...

  • Associate Specialist

    3 months ago


    india ArisGlobal Full time

    ArisGlobal is a dynamic and growing global software company dedicated to serving the Life Sciences industry (pharmaceutical, biotechnology and medical device) in the management of their clinical trials, drug safety and regulatory information. Our global team – located in major corners of the world – includes some of the industry’s leading authorities,...