Medical Safety Writer- Aggregate Reports

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 not limited to:
- Lead preparation of global periodic safety reports for newly launched products.
- Lead coordination with GLFs to ensure information received, analyzed, and incorporated into ARs as per the regulatory requirements.
- Independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards
- Support in creating strategy for data analyses and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs.
- Support in the development of safety document templates and Standard Operating; Procedures pertaining safety aggregate reports. Contribute to global projects focusing on process & quality improvement initiatives.
- Train and mentor new CMO&PS associates and associates from other line functions on medical safety writing & periodic reporting matters. Support Head, Safety Report.

**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**
- Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent Degree
- 4 to 8 years’ experience in drug safety/ development or closely related areas of responsibility, with a minimum of 3 years’ experience in in safety/medical/scientific/regulatory writing
- Preferably, at least 2 years of experience in safety writing; Sound expertise in data analysis and presentation
- Strong project management and communication skills. Ability to lead global and cross-functional work groups
- Excellent understanding of drug development process, GCP and medical terminology. Ability to mentor and guide

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**
- Global Drug Development

**Business Unit**
- CMO & PATIENT SAFETY GDD

**Country**
- India

**Work Location**
- Hyderabad, AP

**Company/Legal Entity**
- Nov Hltcr Shared Services Ind

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No


  • 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 Writer I

    4 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...

  • 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...

  • 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...


  • Hyderabad, Telangana, India Graynwhite Full time

    Role**:Medical Writing Coordinator** Location**:Hyderabad, India (onsite)** Experience**:3-4 years** - **Immediate Joiner**_ We are seeking a dynamic individual to join our team as a Project Coordinator cum Medical Writer. Based in **Hyderabad**, this role offers the opportunity to work **onsite **and contribute to our exciting projects in the...


  • Hyderabad, India Medicover Hospitals Full time

    **Medical Content writer**: 3 to 5yrs Hyderabad Any Graduate or Post Graduate Posted On: 2023-04-05


  • Hyderabad, Telangana, India Thermo Fisher Scientific Full time

    Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...

  • Regulatory Writer

    1 month ago


    Hyderabad, India Novartis Full time

    900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...


  • Hyderabad, Telangana, India Graynwhite Full time

    Role**:Medical Writing Coordinator** Location**:Hyderabad, India (onsite)** Experience**:3-4 years** We are seeking a dynamic individual to join our team as a Project Coordinator cum Medical Writer. Based in **Hyderabad**, this role offers the opportunity to work **onsite **and contribute to our exciting projects in the **healthcare...


  • Hyderabad, Telangana, India Graynwhite Full time

    Role**:Medical Writing Coordinator** Location**:Hyderabad, India (onsite)** Experience**:1.5 -3 years** We are seeking a dynamic individual to join our team as a Project Coordinator cum Medical Writer. Based in **Hyderabad**, this role offers the opportunity to work **onsite **and contribute to our exciting projects in the **healthcare...

  • Content Writer

    4 weeks ago


    Hyderabad, India Kanary Staffing Pvt. Ltd. Full time

    One of our leading IT Product Clients in Hyderabad is looking for Content Writer / lead (Marathi). Experience: 1 - 5 Years Location: Hyderabad Mode of work : Work from Office Notice Period : 1 Week or less Skills: Fluent Speaking and Content Writing in Marathi Responsibilities and Duties: Aggregate news from online/web sources, edit news and submit on...

  • 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...

  • Medical Scribe

    1 month ago


    Hyderabad, India Arya Medical Billing Services Full time

    **Job description** Greetings from Arya Medical Billing Services! We urgently require an experienced Medical Scribe to join us and work in the night shifts. **Position**:Medical Scribe **Experience**:2 to 5 years **Work Mode**:Completely Work from Office (WFO) and Night Shifts. **Skills Required**: - Good communication skills in English (both verbal...


  • Hyderabad, Telangana, India Novartis Full time

    **Summary**: To write and/or edit under guidance high quality clinical and safety documents: non registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents or Patient Narratives **About the Role**: - Scientific Writer II - Location - Hyderabad #LI Hybrid - About the Role: - To write and/or...


  • hyderabad, India Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...


  • Hyderabad, India Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...

  • Scientific Writer II

    3 weeks ago


    Hyderabad, India Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Content Writer

    23 hours ago


    Hyderabad, India BHAROSA Society Full time

    Criteria Requirement **Qualification** : Bachelors degree in Literature,Communicatios, English, journalism, or related field (or relevant experience). Proven work experience of 2 yrs into content writing **Gender**: Any We are looking to engage a full time Content Writer who would help in the following activities: **1. Event Details updation on...


  • Hyderabad, India PrimEra Medical Technologies Full time

    We are seeking an experienced and knowledgeable Director of Medical Coding with expertise in US Healthcare In patient & Out Patient coding. The ideal candidate will have a deep understanding of medical coding systems, including ICD-10, CPT, and HCPCS, as well as coding guidelines and regulations. The Director will be responsible for leading a team of medical...