Medical Safety Associate

1 month ago

Hyderabad, India Novartis Full time

2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact This is one such role.
- Your responsibilities include, but are not limited to:
- Provide support according to the needs for delivery activities, co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
- Archiving all safety documentation as per respective policies, guidance, and procedures. Updating the Medical Safety SharePoint, uploading of documents, tracking and planning list updates
- Verification and update of respective PS archiving system (incl. review, update, management); Monitoring of the compliance. Support in organizing response to queries from Countries and regions and other functions outside medical safety
- Support in developing, updating, and implementing global procedures to ensure compliance. Management and maintenance of relevant Global PS databases/sharepoint.
- Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to HA, development and implementation of corrective action(s) as needed.
- Preparing metrics as required and agreed with the manager. Support the Group Head, Medical Safety Operations/Medical Safety Group Lead/ Associate director Global Risk Management/ Associate director Quantitative safety and MedDRA in day to day operations as per assigned responsibilities
- Support Literature review for PSUR inclusion and assessment of literature for signals. Reviewing HA assessment reports and engaging and supporting the appropriate safety leads to address the questions by the HA
- Support in preparation of responses to internal safety requests and contribute to responses to external safety queries

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD or Life sciences graduate.
- 1-2 years in patient safety. Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries
- Good understanding of clinical trial methodology, ICH GCP, GVP guidelines and medical terminology. Attention to detail and quality focused
- Good communication skills, and the ability to operate effectively in an international environment
- Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis

**Division**
- Novartis Technical Operations

**Business Unit**
- NTO SANDOZ TECHOPS

**Country**
- India

**Work Location**
- Hyderabad, AP

**Company/Legal Entity**
- Sdz Pvt Ind

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

  • Medical Safety Expert

    4 weeks ago

    Hyderabad District, Telangana, India Sdz Pvt Ind Full time

    Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and...

  • Medical Reviewer

    2 months ago

    Hyderabad, India ProPharma Group Full time

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...

  • Medical Reviewer

    2 months ago

    hyderabad, India ProPharma Group Full time

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...

  • Jobs For Clinical Research Associate-Medical

    2 weeks ago

    hyderabad, India Seven Consultancy Full time

    JOB DETAILS 1. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice (GCP) guidelines, and other applicable regulatory requirements.2. Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP...

  • Clinical Research associate-Reputed Medical

    2 weeks ago

    hyderabad, India Seven Consultancy Full time

    JOB DETAILS 1) Creating and writing trial protocols, and presenting these to steering committee.2) Identifying, evaluating and establishing trial sites, and closing sites down on completion of trial.3) Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion.4) Liaise with ethics...

  • Safety Auditor

    4 weeks ago

    Hyderabad, Telangana, India Bayleaf HR Solutions Pvt Ltd Full time

    Job Title: Safety AssociateDepartment: QuestLocation: [Delhi/LKR/NUP/EUP]Job Summary:The Safety Associate will play a crucial role in promoting and maintaining a safe and compliant work environment within the organization. This position involves actively participating in safety initiatives, conducting audits, and supporting the development and implementation...

  • Medical Dosimetrist

    2 weeks ago

    hyderabad, India 0548 Varian Medical Systems Int’l (India) Pvt Ltd Full time

    Together, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers,...

  • Medical Dosimetrist

    3 weeks ago

    Hyderabad, India 0548 Varian Medical Systems Int’l (India) Pvt Ltd Full time

    Together, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers,...

  • Medical Physicist

    4 days ago

    hyderabad, India 0548 Varian Medical Systems Int’l (India) Pvt Ltd Full time

    Together, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers,...

  • Safety Case Expert

    1 month ago

    Hyderabad, Telangana, India Novartis Full time

    Your responsibilities include, but are not limited to: - Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents and product and event coding, narrative writing and follow-up for missing or other medical important information. Including daily...

  • Safety Writer

    1 month ago

    Hyderabad, India Novartis Full time

    2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety. - Your responsibilities include, but are...

  • Medical Billing Associate

    4 weeks ago

    Hyderabad, India Orbysol Systems Pvt. Ltd. Full time

    Greetings from Orbysol !! Non Voice Process - U S Healthcare. Designation: Medical Billing Associate. Accurate processing and completion of medical claims with in current turnaround standards by maintaining quality standards. **Responsibilities and Duties** Demographic entry and charge entry. Payment posting. Demonstrate increasing productivity to meet...

  • Medical Billing Associate

    4 weeks ago

    Hyderabad, India Orbysol Systems Pvt. Ltd. Full time

    Greetings from Orbysol !! Non Voice Process - U S Healthcare. Designation: Medical Billing Associate. Accurate processing and completion of medical claims with in current turnaround standards by maintaining quality standards. **Responsibilities and Duties** Demographic entry and charge entry. Payment posting. Demonstrate increasing productivity to meet...

  • Medical Writer I

    3 days ago

    Hyderabad, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Job Purpose:   Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews...

  • Tl- Medical Information Call Center

    1 month ago

    Hyderabad, India 4C Drug Safety Services LLP Full time

    **Responsibilities**: 3. Complete case entry including case narrative writing, coding from the MedDRA dictionary and WHO drug dictionary as per applicable SOPs and Client requirements. Perform Call handler/QC Reviewer activity as needed. Send the reviewed and signed TCFs/ CDRs to the Client’s point of contact (POC). 4. Responsible for adding/ updating new...

  • Associate Medical Expert

    1 month ago

    Hyderabad, Telangana, India Novartis Full time

    108,000 people reimagining medicine for more than 799 million people globally. Be part of this journey by representing a group that delivers medical communication solutions across multiple franchises, business units and affiliates. Our services and customized solutions enhance the reach of clinical data about relevant therapeutic advancements and supports in...

  • Drug Safety Associate

    4 weeks ago

    Hyderabad/ Secunderabad, India timesjobs Full time

    Job Desciption Responsibilities Receiving and answering calls from people requiring medical services or clarifications regarding a Medical Entity or Medical Device or Vaccines or Cosmetics.Understanding the requirements of the callers and provide precise information during Inbound/Outbound calls.Working quickly by multi-tasking and demonstrating the ability...

  • Functional Safety Engineer

    3 weeks ago

    Hyderabad, India Applycup Hiring Solutions | Top Recruitment & Staffing Agency Full time

    Work Experience: 7-12 yearsLocation: HyderabadConduct safety analysis activities collaborating with the onsite Principal FSM & global team as needed.Collaborate closely with the senior leaders across the other COE functions in Hyderabad.Create documents and/or evidence packages to support certification of roadmap or custom software projects.Partner with...

  • Functional Safety Engineer

    3 weeks ago

    Hyderabad, India Applycup Hiring Solutions | Top Recruitment & Staffing Agency Full time

    Work Experience: 7-12 yearsLocation: HyderabadConduct safety analysis activities collaborating with the onsite Principal FSM & global team as needed.Collaborate closely with the senior leaders across the other COE functions in Hyderabad.Create documents and/or evidence packages to support certification of roadmap or custom software projects.Partner with...

  • Clinical Research Associate

    4 weeks ago

    Hyderabad, India Learning Labb Research Institute Full time

    As a Clinical Research Associate, you'll play a pivotal role in ensuring the successful execution of clinical trials. From monitoring trial progress to ensuring regulatory compliance and participant safety, you'll be at the forefront of cutting-edge medical research.Key Responsibilities:- Conduct site visits to monitor trial activities and ensure compliance...