![Sitero LLC](https://media.trabajo.org/img/noimg.jpg)
Medical Reviewer
1 week ago
Medical Reviewer
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry.
We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths.
For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title:
Medical Reviewer
Location:
Mysore/Hybrid
Function:
Drug Safety
DESCRIPTION:
Medical Reviewer is the key contact person for assigned clinical development or marketed products, responsible for safety strategy and major safety deliverables, including both early and late-stage development, as assigned.
The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners.
He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Analyzes, reviews, and interprets safety data, both nonclinical and clinical.
- Performs medical review of ICSRs, and other drug safety information from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate and literature reports.
- Provides technical and medical expertise in medical assessment of causality of Individual Case Safety Report (ICSR) as necessary, including the assessment of quality within the ICSR process; identifies process improvement opportunities and drives changes.
- Contributes to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements.
- Contributes to the development of Standard Operating Procedures, Working Instructions and other guidance documents.
- Contributes to safety and pharmacovigilance training programs.
- Provides safety training at investigator meetings.
- Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
- Training and mentoring of Pharmacovigilance Physicians and Specialists.
- Demonstrates knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, FDA, PMDA, EMA, ICH, etc.).
EDUCATION AND EXPERIENCE REQUIRED:
- 13 years' experience in Clinical Practice required. 1+ yr of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products is preferable.
- Medical Degree (MBBS or higher) from recognized medical school.
PREFERRED SKILLS:
- Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
- Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities.
- Proficiency with medical review of ICSRs, including coding and use of SMQs, expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements, including benefitrisk assessment.
- Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and postmarketing environment).
- Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
- Excellent verbal, written and presentation skills.
- Innovative, collaborative, initiativetaker.
COMPENSATION & BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE:
Permanent, Full Time
COMMITMENTS:
- Standard Hours 40 hours per week, one hour lunch, Monday
- Friday. Additional hours as needed.
- Willing to work in shifts as and when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin,
-
Associate - Dialysis
1 week ago
Mysore, Karnataka, India Manipal Health Enterprises Full timeDate:18 Jun 2024Location: Mysuru, INCompany:Manipal Health Enterprises Private LtdAbout Us:Manipal Hospitals: Empowering Health, Enriching LivesWelcome to Manipal Hospitals, where our commitment to exceptional healthcare goes beyond conventional boundaries. At Manipal Hospitals, our commitment to patient-centricity, ethical practices, and clinical excellence...
-
Clinic Physician Jobs in Vidpro, Mysuru
3 weeks ago
Mysore, Karnataka, India Vidpro, Swaasa Jobs Full timeJob Requirements Job Title: PhysicianJob Location: MysoreJob Overview: We are seeking a highly skilled and compassionate medical professional to join our team. The Physician will be responsible for conducting pre-insurance medical examination. This includes diagnosing a wide range of illnesses for insurance applicants during pre-insurance medical check-up...
-
Clinic Physician Jobs in Vidpro, Mysuru
1 week ago
Mysore, Karnataka, India Vidpro, Swaasa Jobs Full timeJob Requirements Job Title: PhysicianJob Location: MysoreJob Overview: We are seeking a highly skilled and compassionate medical professional to join our team. The Physician will be responsible for conducting pre-insurance medical examination. This includes diagnosing a wide range of illnesses for insurance applicants during pre-insurance medical check-up...
-
Clinic Physician Jobs in Vidpro, Mysuru
3 weeks ago
Mysore, Karnataka, India Vidpro, Swaasa Jobs Full timeJob Requirements Job Title: PhysicianJob Location: MysoreJob Overview: We are seeking a highly skilled and compassionate medical professional to join our team. The Physician will be responsible for conducting pre-insurance medical examination. This includes diagnosing a wide range of illnesses for insurance applicants during pre-insurance medical check-up...
-
Assistant Manager- Talent
1 week ago
Mysore, Karnataka, India AccorHotel Full timeAssistant Manager- Talent & CultureThis role involves providing administrative support to colleagues in the Talent & Culture department to ensure the smooth and precise execution of various initiatives and projects.Handle day-to-day Talent & Culture administrative tasks accurately and promptlyConduct regular audits of candidate filesOrganize new ambassador's...
-
Lab Supervisor
1 week ago
Mysore, Karnataka, India Lupin Diagnostics Full timePosted date: June 09, 2023Function/Business Area: Lab SupervisorLocation: MysoreExperience: 8+Yrs**- Performing internal quality control procedures and daily QC checks. Maintain Quality documentation as per lab policies and procedures. Perform preventive maintenance and calibration of laboratory instruments/equipment as per the defined program in the...
-
Drug Safety Associate
1 week ago
Mysore, Karnataka, India Sitero LLC Full timeDRUG SAFETY ASSOCIATE - JOB DESCRIPTIONSitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through...
-
Drug Safety Associate Trainee
1 week ago
Mysore, Karnataka, India Sitero LLC Full timeDRUG SAFETY ASSOCIATE TRAINEE- JOB DESCRIPTIONSitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies...
-
Drug Safety Scientist
1 week ago
Mysore, Karnataka, India Sitero LLC Full timeDrug Safety Scientist - JOB DESCRIPTIONSitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through...
-
Senior Engineer
1 week ago
Mysore, Karnataka, India LTTS Full timeDuties and responsibilities Provide Computational Intelligence subject-matter expertise on work related to Healthcare Data Analysis, Model Development and Deploying Analytical solutions Help develop strategy for the CoE and service delivery to align with expectations of key (internal /External) stakeholders Share (business / technical) knowledge and...
-
General Surgeon
1 week ago
Mysore, Karnataka, India Chaitanya HR Consultancy Full time***: Examining patients and making diagnoses to determine the need for surgery. Reviewing patients' medical history and planning the best procedure for treatment. Evaluating and advising patients on the risk involved with having surgery. Performing surgical procedures to prevent or correct injury, disease, deformities, and patient function while adhering to...
-
Respiratory Therapist
1 week ago
Mysore, Karnataka, India Chaitanya HR Consultancy Full timeMonitoring patient physiological responses to therapy such as arterial blood gases, vital signs or blood chemistry, and lung function changes, and consulting with physicians if there are adverse reactions. Working as part of a team of health care professionals to manage patient care by assisting with medical procedures. Setting up and operating devices...
-
Associate - Respiratory Medicine
1 week ago
Mysore, Karnataka, India Manipal Hospitals Full timeAbout Us Manipal Hospitals: Empowering Health, Enriching Lives Welcome to , where our commitment to exceptional healthcare goes beyond conventional boundaries. At Manipal Hospitals, our commitment to patient-centricity, ethical practices, and clinical excellence is at the core of everything we do. As a leading healthcare provider, we are dedicated...
-
Associate - Respiratory Medicine
1 week ago
Mysore, Karnataka, India Manipal Health Enterprises Full timeDate:4 Jun 2024Location: Mysuru, INCompany:Manipal Health Enterprises Private LtdAbout Us:Manipal Hospitals: Empowering Health, Enriching LivesWelcome to Manipal Hospitals, where our commitment to exceptional healthcare goes beyond conventional boundaries. At Manipal Hospitals, our commitment to patient-centricity, ethical practices, and clinical excellence...
-
Junior Associate
1 week ago
Mysore, Karnataka, India Manipal Health Enterprises Full timeDate:16 Jun 2024Location: Mysuru, INCompany:Manipal Health Enterprises Private LtdAbout Us:Manipal Hospitals: Empowering Health, Enriching LivesWelcome to Manipal Hospitals, where our commitment to exceptional healthcare goes beyond conventional boundaries. At Manipal Hospitals, our commitment to patient-centricity, ethical practices, and clinical excellence...
-
Application Developer: Cloud FullStack
1 week ago
Mysore, Karnataka, India IBM Full timeIntroductionIn this role, you'll work in one of our IBM Consulting Client Innovation Centers (Delivery Centers), where we deliver deep technical and industry expertise to a wide range of public and private sector clients around the world. Our delivery centers offer our clients locally based skills and technical expertise to drive innovation and adoption...
-
Medical Reviewer
4 weeks ago
Mysore, India Sitero LLC Full time**Medical Reviewer** Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III...
-
Medical Scribe
3 weeks ago
Mysore, India Eliscription Pvt Ltd Full timeResponsibilities: - Assist healthcare providers in documenting patient encounters, procedures, and medical histories - Accurately transcribe medical information into electronic health records (EHR) systems - Maintain confidentiality and adhere to HIPAA regulations when handling patient information - Collaborate with healthcare team members to ensure...
-
Medical Scribe
1 week ago
Mysore, India Eliscription Pvt Ltd Full timeResponsibilities: - Assist healthcare providers in documenting patient encounters, procedures, and medical histories - Accurately transcribe medical information into electronic health records (EHR) systems - Maintain confidentiality and adhere to HIPAA regulations when handling patient information - Collaborate with healthcare team members to ensure...
-
Medical Writer
4 weeks ago
Mysore, India Sitero LLC Full timeSitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our...
-
Medical Writer
2 weeks ago
Mysore, India Sitero LLC Full time**DESCRIPTION**: The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations,...
-
Medical Claim
3 weeks ago
Mysore, Mysuru, Karnataka, India Thought Focus Full timeJOB SUMMARY The Claims Processor will review and adjudicate claims verifying eligibility, approval of services, and accurate pricing. Education: Bachelor’s Degree Experience: 3 to 5 years of medical claims billing and claims processing experience with mandatory knowledge of CPT4 and ICD10 codes. KEY JOB RESPONSIBILITIES - Completes accurate analysis of...
-
Lab Supervisor
3 weeks ago
Mysore, India Lupin Diagnostics Full time**Posted date**: June 09, 2023 **Function/Business Area**: Lab Supervisor **Location**: Mysore **Experience**: 8+Yrs **- Performing internal quality control procedures and daily QC checks. Maintain Quality documentation as per lab policies and procedures. - Perform preventive maintenance and calibration of laboratory instruments/equipment as per the...
-
Urologist
2 weeks ago
Mysore, India Chaitanya HR Consultancy Full timeExamining, diagnosing, and treating patient conditions and disorders of the genitourinary organs and tracts. - Documenting and reviewing patients’ histories. - Ordering, performing, and interpreting diagnostic tests. - Using specialized equipment, such as X-rays, fluoroscopes, and catheters. - Performing abdominal, pelvic, or retroperitoneal surgeries when...
-
Us Payroll Executive
2 weeks ago
Mysore, India Equalize RCM Full timeMaintains compliance with federal, state, and local employment laws and regulations, and recommended best practices; reviews policies and practices to maintain compliance. - Maintains knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law. - Review various tax notices and work...
-
Drug Safety Associate
4 weeks ago
Mysore, India Sitero LLC Full time**DRUG SAFETY ASSOCIATE - JOB DESCRIPTION** Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies...
-
Drug Safety Scientist
4 weeks ago
Mysore, India Sitero LLC Full time**Drug Safety Scientist - JOB DESCRIPTION** Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies...
-
Respiratory Therapist
2 months ago
Mysore, India Chaitanya HR Consultancy Full timeMonitoring patient physiological responses to therapy such as arterial blood gases, vital signs or blood chemistry, and lung function changes, and consulting with physicians if there are adverse reactions. - Working as part of a team of health care professionals to manage patient care by assisting with medical procedures. - Setting up and operating devices...
-
Drug Safety Associate Trainee
4 weeks ago
Mysore, India Sitero LLC Full time**DRUG SAFETY ASSOCIATE TRAINEE- JOB DESCRIPTION** Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase...
-
General Surgeon
2 weeks ago
Mysore, India Chaitanya HR Consultancy Full time***: - Examining patients and making diagnoses to determine the need for surgery. - Reviewing patients’ medical history and planning the best procedure for treatment. - Evaluating and advising patients on the risk involved with having surgery. - Performing surgical procedures to prevent or correct injury, disease, deformities, and patient function while...
-
Application Developer: Cloud FullStack
1 week ago
Mysore, India IBM Full timeIntroduction In this role, you'll work in one of our IBM Consulting Client Innovation Centers (Delivery Centers), where we deliver deep technical and industry expertise to a wide range of public and private sector clients around the world. Our delivery centers offer our clients locally based skills and technical expertise to drive innovation and...