Medical Safety Expert
3 months ago
**Summary**:
Provide support for medical safety management within the Patient Safety & Pharmacovigilance department, including medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co
- authoring safety
documents, assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Provide support to the safety lead by creating quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with patient safety business rules, standard operating procedures and global and local regulatory requirements.
Provide support to defines, develop and implement metrics, standard and tool to oversee efficiently the performance of the Pharmacovigilance and Medical Devices Vigilance system in regard to medical review of safety cases and management of safety signals.
**About the Role**:
**Major accountabilities**:
- Perform medical review of ICSRs including (SUSARs, cases from special countries), assessment of Literature cases and authoring of enhanced MAC.
- Support safety lead for authoring medical assessment letters based on the bi-annual/six monthly line listing.
- Perform literature review of assigned articles (CQC, pre-screening and SICO) and assist safety lead in review of articles for inclusion in PBRER, DSUR, IB etc.
- Provide rotating support to the TAs as per the business needs, (i.e. co-authoring safety documents, assisting in providing safety input to regulatory and clinical documents).
- Assist the TA Safety Leads in monitoring the safety profile of products including but not limited to the activities such as literature review, medical review of individual cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects.
- Together with the Safety Leads, co-author of the PBRER. Provides medical inputs to the sections 9, 15, 16, 17, 18, including analytical input to PBRER for risks defined in the RMP. Perform follow up activities on HA assessment reports.
- Co-authors and contributes to the medical sections of Development Safety Update Report (DSUR), Investigator Brochures (IB), labelling documents (e.g. CDS, (SMPC, USPI, Japanese PI), Product Guidance Documents (PGD)
and Expert Statements.
- Supports the preparation and review of Investigator Notifications (INs).
- Provide support signal detection and signal evaluation activities for assigned products.
- Provide support for the preparation of Health Authority queries.
- Assists Safety Leads in evaluating and writing other safety related documents including but not limited to Clinical Overview, Development Safety Profiling Plan (d-SPP) and RMP.
- Provides safety input to Addendum to Clinical Overview (ACO) for license renewal.
- Provides support as needed for new indication submission (regulatory document safety input).
- Supports the safety lead for preparation and participation on internal review meetings like, SMT, MSRB and GLC.
- Act as Subject Matter Expert (SME) for Medical Function process and provide support during audit and inspections.
- Collaborate with other Global Line Functions across Novartis and Third Parties to meet joint accountabilities.
- Contribute to PV&PV initiatives as well as cross-functional projects to optimize medical review processes and quality.
- Contribute to development and optimization of training materials. Deliver training to the Novartis staff and external.
**Minimum Requirement**:
- Bachelor of Science in Pharmacy /Bachelor of Science in Nursing / PharmD/PhD in relevant field or Medical Degree (MBBS or MD) required. Minimum 3yrs of experience in the pharmaceutical industry or related. Experience in safety document or medical writing including experience coding with MedDRA and WHO dictionaries.
- Excellent understanding of clinical trial methodology, ICH GCP, GVP guidelines
and medical terminology
- Attention to detail and quality focused
- Strong organizational and project management skills
- Strong communication skills, and the ability to operate effectively in an
international environment
- Excellent understanding of Human physiology, pharmacology, clinical study
objectives, and the drug development process
- Strong technical understanding of Biomedical/Biostatics concepts and problem-solving skills
- Good presentation skills
- Strong computer skills including, but not limited to, creation of spreadsheets,
- Ability to work independently, under pressure, demonstrating initiative and
flexibility through effective innovative leadership ability.
Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment an
-
Medical Safety Expert
7 months ago
Hyderabad District, Telangana, India Sdz Pvt Ind Full timeResponsible 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 Safety Expert
2 months ago
Telangana, India Sandoz Full time**Major accountabilities**: - 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. - Assist the GPSL/MSL/MSE in monitoring the safety profile of products including with activities such as...
-
Medical Safety Review Expert
6 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeAt Bristol Myers Squibb, we are committed to transforming patients' lives through science.We are currently seeking an Associate Director, Medical Safety Review to join our team in this exciting opportunity!About the RoleThis is a site-essential role requiring 100% of shifts onsite at your assigned facility. As a member of our Worldwide Patient Safety group,...
-
Safety Case Expert
6 months ago
Hyderabad, Telangana, India Novartis Full timeYour 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 Safety Review Lead
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob DescriptionJob SummaryThe Associate Director, Medical Safety Review will provide high-quality medical review of Individual Case Safety Reports (ICSRs), including determination of regulatory reportability of clinical trial cases and certain post-marketing reports. The role supports signal detection and risk management-related activities.Key...
-
Associate Medical Expert
6 months ago
Hyderabad, India Novartis Full time387199BR **Associate Medical Expert**: India **About the role** Associate Medical Expert Location - Hyderabad #LI Hybrid About the Role: The Associate Medical Expert will ensure the successful implementation and delivery of the Medical and Knowledge Solutions (MKS) scientific and medical services along the business colleagues’ requirements. He/ she is...
-
Medical Store Assistant
3 months ago
Alwal, Hyderabad, Telangana, India Vel Medical store Full time**Job Title**: Medical Store Assistant **Location**: Alwal, Hyderabad **Experience**: 1-2 years (in a similar or related role) **Job Summary**: **Key Responsibilities**: - Assist customers with their inquiries, providing accurate information about medications and healthcare products. - Accurately process prescriptions under the guidance of a licensed...
-
Director of Medical Safety Oversight
6 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJoin a team that shares your passion for transforming patients' lives through science. We're seeking a talented Director of Medical Safety Oversight to lead our medical review efforts and ensure the safety of our medicines.About the RoleThis is an exciting opportunity to leverage your expertise in medicine and pharmaceutical product safety to drive...
-
Medical Sales Expert
3 weeks ago
Hyderabad, Telangana, India ARVIK MEDICAL SYSTEMS LLP Full timeMedicine Sales RoleRepresent ARVIK MEDICAL SYSTEMS LLP in the medical sector by promoting and selling their medications to healthcare professionals, such as doctors and pharmacists.Key Responsibilities:Schedule appointments with healthcare professionals to present company medications.Develop in-depth knowledge of company medications.Build and maintain...
-
Expert Regulatory Writer
6 months ago
Hyderabad, Telangana, India Novartis Full time392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...
-
Medical Data Safety Specialist
2 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob DetailsThis is a Medical Data Safety Specialist role where you will be part of the Pharmacological Department. Your key responsibility will be to report adverse effects and side effects, in accordance with current Dutch and European legislation for pharmacology.You may also train colleagues in departments such as marketing and sales, medical and clinical...
-
Associate Director, Medical Safety Review
5 months ago
Hyderabad, India Bristol Myers Squibb Full timeDescription The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning...
-
Medical Devices Quality Assurance Expert
4 weeks ago
Hyderabad, Telangana, India Medtronic Full timeMedical Devices Quality Assurance Expert: ## Careers that Make a Difference At Medtronic, we're dedicated to providing cutting-edge medical devices that change lives. As a Medical Devices Quality Assurance Expert, you'll play a vital role in ensuring our products meet the highest standards of quality and safety. Your responsibilities will include...
-
Medical Coding Manager, Worldwide Patient Safety
4 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking a highly skilled Medical Coding Manager to join our Worldwide Patient Safety team. As a key member of our global team, you will be responsible for delivering accurate and consistent medical coding within established timelines and in compliance with all processes, guidelines, and conventions.Key ResponsibilitiesDeliver high-quality...
-
Certified Safety Proffessional
5 months ago
Hyderabad, Telangana, India IOT Research Labs Full time**About SafetyConnect**: SafetyConnect is a rapidly expanding B2B SaaS company in the Environment Health and Safety (EHS) sector, dedicated to reducing accidents through our AI-driven safety solutions. Our Driving Safety Solution leverages AI to monitor and improve driving behavior for sales and service field forces, proactively preventing accidents and...
-
Medical Expert
3 weeks ago
Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full timeJob SummaryWe are seeking a highly skilled Medical Advisor to provide scientific expertise for our Therapeutic Area medical strategy. The ideal candidate will have a strong academic record, deep knowledge of the therapeutic area, and experience in medical activities, research, and publications.Responsibilities• Provide scientific foundation for the...
-
Associate Director, Medical Safety Review
1 month ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryWe are seeking an experienced Associate Director, Medical Safety Review to join our team at Bristol Myers Squibb. This role will be responsible for providing high-quality medical review of Individual Case Safety Reports (ICSRs) and supporting signal detection and risk management activities.Key ResponsibilitiesProvide medical assessment of ICSRs...
-
Safety Supervisor
5 months ago
Manikonda, Hyderabad, Telangana, India Anuhar Homes Private Limited Full time**Job Summary** The position will be responsible to ensure work place safety by adhering to established standards and pre-defined procedures **Responsibilities and Duties** - Assist in ensuring compliance with relevant laws and statutes such as Building And Other Construction Workers Act, 1996 - Ensure all employees are in compliance with safety norms -...
-
Safety Scientist, Expedited Safety Reporting
6 months ago
Hyderabad, Telangana, 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...
-
Safety Standards Expert
4 weeks ago
Hyderabad, Telangana, India RC Project Consultancy (RCPC) Full timeWe are seeking a highly skilled and experienced Safety Standards Expert to join our team at RC Project Consultancy (RCPC). This role requires a strong professional with a deep understanding of high-rise building projects and a proven track record in managing HSE initiatives.The ideal candidate will possess a B.Tech / Diploma / Government recognized Diploma...