Clinical Safety Physician

1 day ago


Mumbai, Maharashtra, India Tata Consultancy Services (TCS) Full time ₹ 15,00,000 - ₹ 30,00,000 per year

TCS is Hiring -Clinical Safety Physician

location - Mumbai, Noida, Bengaluru

Experience Range - 5 to 10

Preferred Educational Qualification for the role - MBBS/MD

Job Description

Literature Review

Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).

Provide MAH comments for selected literature

Review of Literature Strategy

Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.

Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic).

Review and interpretation of current expert therapeutic guidelines for the purpose of various safety analyses.

Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria

Aggregate Reports:

Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER.

Authoring of RMP updates & implementation plans.

Provides methodology (in collaboration with Roche clinical safety) for data presentation and assessment in the pertinent safety sections of the aggregate report (use outside the indication scope, use in special population, medication errors, characterization of risks etc.)

Asses the new information received on important safety concerns for the medicinal product.

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Signal Management

Review of various types of listings for Signal Detection

Understanding of signal journey and knowledge of signal management systems and process requirements.

Perform Signal validation with a brief summary.

DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review

Tailoring strategy and methodology for signal assessment

Overall assessment of the signal based on the presented data and respective recommendation for action

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Location

Mumbai

Job Function

BUSINESS PROCESS SERVICES

Role

Executive

Job Id

374080

Desired Skills

Life Sciences Domain

Desired Candidate Profile

Qualifications : MBBS, MD


  • Clinical Science Lead

    2 weeks ago


    Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Collaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis.Lead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory...


  • Mumbai, Maharashtra, India Tata Consultancy Services (TCS) Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    TCS is Hiring - Clinical Safety Scientistlocation - Mumbai, Noida, BengaluruExperience Range - 5 to 10Preferred Educational Qualification for the role - M.Pharma, MSC, BSC, BDS, MDS, B.Tech, M.TechJob DescriptionLiterature ReviewLiterature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety...


  • Mumbai, Maharashtra, India Cipla Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Job descriptionTitle: Team Member/Manager Safety Clinical R&DJob Location-Vikhroli, MumbaiPrepare clinical development plan to ensure conduct of clinical studies as per regulatory requirementsPrepare strategy for the molecule about the design, sample size depending upon the market for conduct of the study, and present the same in cross-functional...

  • Clinical Supervisor

    4 days ago


    Mumbai, Maharashtra, India OpenPixel Web Solutions Private Limited Full time ₹ 3,00,000 - ₹ 6,00,000 per year

    Busy Practice Seeking:Clinical Co-Cordinator / Co -Clinical Supervisor:Looking for a Medical Doctor with MBBS, BBS, BAMS, or BHMS, who has strong attention to detail , understanding of medical terminology , medications and has good oral and written english skills. Candiate will be responsible for maintaining patient's charts , writting office notes, as well...


  • Mumbai, Maharashtra, India Sanskara Hearing Solutions Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job Summary:We are seeking a compassionate and skilled Audiologist to join our Hearing Solution Clinic. The Audiologist will assess, diagnose, and treat hearing and balance disorders. The ideal candidate will provide exceptional care to patients, ensuring they receive the best possible treatment options for their hearing and communication needs.Key...


  • Mumbai, Maharashtra, India Medico Hub Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Contact Mr Nishant Chaudhary WhatsApp  About the OpportunityA multispecialty healthcare provider operating in primary and secondary care, delivering inpatient and outpatient clinical services across surgical and medical specialties in Ulhasnagar, Maharashtra. We are expanding our on-site clinical team and seeking full-time Consultant Physicians across...


  • Mumbai, Maharashtra, India BOSTON SCIENTIFIC Full time € 60,000 - € 1,20,000 per year

    Job Description Sr Clinical Trial Manager, Oncology Work mode: Remote in CountryOnsite Location(s): Diegem, Belgium At Boston Scientific, were committed to transforming lives through less invasive products and technologies that diagnose and treat a wide range of medical conditions. Our innovations span key therapeutic areas and are expanding into new...


  • Mumbai, Maharashtra, India SYS MEDTECH INTERNATIONAL PVT LTD Full time ₹ 3,96,000 per year

    Job Description – Clinical Research Specialist - (3 to 6 years' work experience) – AOSYS PVT. LTD.Work Location - We are looking for candidates for Mumbai and Chennai.A Clinical Research Specialist coordinates clinical trials, ensuring compliance with regulations and protocols while managing data and participant safety. They collaborate with various...

  • Safety Writer

    1 week ago


    Mumbai, Maharashtra, India Fortrea Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Overview:Responsible for the preparation and review of aggregate safety, risk management, and signal detection documents. Perform report management activities and lead client communication for the assigned reports. Assist other medical writers in their safety deliverables, act as a co-author for complex or large reports. Provide oversight and quality...


  • Mumbai, Maharashtra, India OMC Medical Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Description: Clinical Application Specialist – Aesthetic DivisionLocation:Mumbai, IndiaCompany:OMC MedicalProduct Line:Premium fat-dissolving and skin revitalization productsNo. of Positions:1 Role OverviewOMC Medical is seeking a skilled and confidentClinical Application Specialist (CAS)to support the onboarding and clinical integration of its newly...