Drug Safety Physician

1 week ago

Mysuru Karnataka, India Sitero LLC Full time

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. He/she is accountable for safety and risk management activities for one or more assigned products. He/she will manage cross-functional assessment of benefit-risk profile and communication of safety information for assigned product(s). 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 non-clinical 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**:

- 1-3 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 benefit-risk assessment.
- Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment).
- Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
- Excellent verbal, written and presentation skills.
- Innovative, collaborative, initiative-taker.

**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, protected veteran s

  • Medical Reviewer

    1 week ago

    Mysuru, Karnataka, India Sitero LLC Full time

    ESSENTIAL DUTIES AND RESPONSIBILITIES: - Analyzes, reviews, and interprets safety data, both non-clinical 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...

  • Aggregate Report Physician

    2 weeks ago

    Bengaluru, Karnataka, India ClinChoice Full time

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice, is searching for an Aggregate Report Physician to join one of our clients. **Main Job Tasks and Responsibilities**: - Aggregate Report...

  • Drug Safety Expert I

    3 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Drug Safety Expert I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety GBS (GS - GBS).- **The Position** - A Drug Safety Expert will be responsible to ensure all the conventions are followed by safety case handlers and would drive quality deliverables, he or she would act as a bridge...

  • General Physician

    2 weeks ago

    Karnataka, India Chaitanya HR Consultancy Full time

    Conduct routine check-ups to patients to assess their health condition and discover possible issues - Give appropriate advice for healthy habits (diet, hygiene etc.) and preventative actions to promote overall health - Conduct examinations to ill patients and evaluate symptoms to determine their condition - Ask intuitive questions to discover causes of...

  • Literature Review Physician

    2 weeks ago

    Bengaluru, Karnataka, India ClinChoice Full time

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Literature Review Physician on a permanent basis. You will work on projects from our varied client base,...

  • Physician Assistant

    2 weeks ago

    Bengaluru, Karnataka, India Belenus Champion Hospital Full time

    **Job Role "Physician Assiatant"| Immediate Requirement (Hospital Experience Mandatory)** Greetings from Belenus Champion Hospitals Pvt. Ltd. **Physician Assistant Role and Responsibilities** - Assess patients’ health and their demands and aim to fulfil them as well as possible. - Issue appropriate prescriptions and administer medicine. - Inform...

  • Critical Care Physician

    2 weeks ago

    Bengaluru, Karnataka, India sourcetrace consulting Full time

    Hi All, We are looking for Critical Care physician for our Healthcare client in bangalore. MBBS+ICU experience we need min 1yr PFB the JD: KEY RESPONSIBILITIES -CCA works closely with the intensivists in providing high quality critical care from our care center, based in Bangalore. -Accompany the intensivist in conducting tele rounds, which involve...

  • Pharmacist

    3 weeks ago

    Mysuru, Karnataka, India Healing Hands Clinic Full time

    **Pharmacy Licence is mandatory** - Compounding and dispensing medications, as prescribed by physicians. - Monitoring customers’ drug therapies, advising interventions, and informing customers of any potential side effects. - Instructing customers on how and when to take prescribed medications. - Consult on dosages, medication substances etc. - Advise on...

  • Cathlab Technician

    1 week ago

    Mysuru, Karnataka, India Manipal Hospitals - Mysore Full time

    **Job description** - Assist physicians in managing cardiac and peripheral vascular disease and cardiac arrhythmias in the Cath lab, in the care of patients undergoing cardiac, Neuro, renal and peripheral vascular procedures. **Duties and Responsibilities of Cath lab Technician** - Assist physicians in managing cardiac and peripheral vascular disease and...

  • Physician Assistant

    2 weeks ago

    Bengaluru, Karnataka, India sparrc Full time

    **CANDIDATES CAN BE APPLIED & RECRUITED ONLY FROM THE BACKGROUND OF LIFESTYLE SPORTS MEDICINE.**: - Roles & Responsibilities: - Assess patients’ health and their demands and aim to fulfill them as well as possible - Issue appropriate prescriptions and administer medicine - Inform physicians about any problems or discrepancies that might arise - Acquire...

  • Physician Assistant

    2 weeks ago

    Bengaluru, Karnataka, India Belenus Champion Hospital Full time

    **Job Role "Physician Assiatant - Obstetrics & Gynaecology"| Immediate Requirement (Hospital Experience Mandatory)** Greetings from Belenus Champion Hospitals Pvt. Ltd. **Physician Assistant Role and Responsibilities** - Assess patients’ health and their demands and aim to fulfil them as well as possible. - Issue appropriate prescriptions and administer...

  • Hospital Pharmacist

    2 weeks ago

    Mysuru, Karnataka, India Iswarya Health Private Ltd Full time

    **Responsibilities**: - Compounding and dispensing medications, as prescribed by physicians. - Monitoring customers’ drug therapies, advising interventions, and informing customers of any potential side effects. - Instructing customers on how and when to take prescribed medications. - Conducting health and wellness screenings. - Providing immunizations...

  • Critical Care Physicians

    4 weeks ago

    Bengaluru, Karnataka, India Docthub Health Tech Private Limited Full time

    **Description** - CCA works closely with the intensivists in providing high quality critical care from our care center, based in Bangalore. - Accompany the intensivist in conducting tele rounds, which involve patient review via camera, discussion with the bedside physicians, review of labs, radiology and drug charts, and compliance to protocols. - Assist the...

  • General Physician

    1 week ago

    Bengaluru, Karnataka, India Bizaccenknnect Pvt ltd Full time

    We are looking for MBBS qualified doctors based out of Bangalore only or willing to relocate.- Should be multilingual (Hindi/Kannada/English/Telugu/Tamil). Should know at least conversational Kannada. - Should be MCI /state medical council registered doctor - Should be comfortable with a split Shift - 9:30 AM to 1:00 PM and 4:00 PM to 8:30 PM - Must have...

  • Senior Associate

    2 months ago

    Mysuru, India Manipal Hospitals Full time

    About 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...

  • Senior Associate

    3 weeks ago

    Mysuru, India Manipal Hospitals Full time

    About 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...

  • General Physician

    2 months ago

    Bengaluru, Karnataka, India Bizaccenknnect Pvt ltd Full time

    We are looking for MBBS qualified doctors based out of Bangalore only or willing to relocate.- Should be multilingual (Hindi/Kannada/English/Telugu/Tamil). Should know at least conversational Kannada. - Should be MCI /state medical council registered doctor - Should be comfortable with a split Shift - 9:30 AM to 1:00 PM and 4:00 PM to 8:30 PM - Must have...

  • General Physician

    1 week ago

    Bengaluru, Karnataka, India Bizaccenknnect Pvt ltd Full time

    We are looking for MBBS qualified doctors based out of Bangalore only or willing to relocate.- Should be multilingual (Hindi/Kannada/English/Telugu/Tamil). Should know at least conversational Kannada. - Should be MCI /state medical council registered doctor - Should be comfortable with a split Shift - 9:30 AM to 1:00 PM and 4:00 PM to 8:30 PM - Must have...

  • General Physician

    1 day ago

    Bengaluru, Karnataka, India Bizaccenknnect Pvt ltd Full time

    We are looking for MBBS qualified doctors based out of Bangalore only or willing to relocate.- Should be multilingual (Hindi/Kannada/English/Telugu/Tamil). Should know at least conversational Kannada. - Should be MCI /state medical council registered doctor - Should be comfortable with a split Shift - 9:30 AM to 1:00 PM and 4:00 PM to 8:30 PM - Must have...

  • General Physician

    6 days ago

    Bengaluru, Karnataka, India Bizaccenknnect Pvt ltd Full time

    **Job description** - We are looking for MBBS qualified doctors based out of Bangalore only or willing to relocate.- Should be multilingual (Hindi/Kannada/English/Telugu/Tamil). Should know at least conversational Kannada. - Should be MCI /state medical council registered doctor - Should be comfortable with a split Shift - 9:30 AM to 1:00 PM and 4:00 PM to...