Pharmacovigilance Coordinator

7 days ago

Mumbai, India ユニ開発ソフトウェアプライベートリミテッド Full time

Position- Pharmacovigilance Coordinator- Reporting to- Team Leader or Manager- Qualifications / Work Experience- Formal Education
- Graduate, preferably in science
- Bachelor’s degree / Masters in Life sciences
- MBBS/BHMS/ BAMS/ BDS/ Paramedical degrees
- B. Pharm/ M. Pharm
- Bachelors / Masters in Clinical research
- University degree in pharmaceutical sciences or other relevant medical or scientific disciplines preferred
Certifications
- Certifications / Diploma in IT &/ CDM
Work Experience
- Previous Data Entry experience preferred- Essential Competencies (Knowledge, Skills and Attributes)- Expected Competency Domain
- Good technical knowledge of medical terminology.
- Compliant with GCP/GCDMP.
- Computer and Internet skills and experience (familiarity and comfort with MS Office products).
- Oral and written English communication skills
- Self-motivated and enthusiastic.
Accountability Domain
- Understand and comply with Standard Operating Procedures.
- Anticipate problems, issues, and proactively work to minimize the impact.
- Maintenance of strict confidentiality in all CAC-India projects.
- Responsible for Data Quality.
- Accountable for customer satisfaction of all CAC-India stakeholders.
- Build constructive and effective relationships with study team, departmental associates and others (both inside and outside the company).
- Key Responsibilities:
- Safety Data Processing
- Review and Assess all source documents and compile data in an adverse event report
- Ensure the completeness of the documents, clinical safety data during data entry and tracking and interact with seniors on timely basis for further clarification if there are any discrepancies.
- Oversees and performs and ensures case receipt and triage activities are completed for Individual Case Safety Reports (ICSRs) from all sources and ensure this is performed in a timely manner Data enter report into the client safety database
- Interact with seniors for additional responsibilities other than Study Documents Tracking and Data Entry.
- Concentrate on quality of work to get error free data.
- Responsible for and ensures the reconciliation of the safety database with ICSR source files.
- Release reports to client through client safety database.
- May be asked to perform ICSR case processing activities as a backup for safety information cases (including initial data entry of safety information, initial determination of seriousness, expectedness, listedness, and Reportability.)
- Perform other related duties as required.
- Effective communication with study teams and departmental associates.
- Additional Information- Industry type
- Pharma/ Biotech/ Clinical research
Functional Area
- Life science
Experience
- Fresher or up to 1/1.5 years of Experience
- Location- Mumbai- Working Hours- As per company policy or depending on Project requirement- Travel- Not Required**Job Code**

**R143**
- E-mail-
- Sub Line- REQ 2019 Q4 R143 Ref: (usindia)

  • Executive - Pharmacovigilance

    2 weeks ago

    Mumbai, Maharashtra, India Piramal Pharma Solutions Full time

    Business: Critical Care Department: Pharmacovigilance Location: Kurla, Mumbai Travel: No **Reporting Structure** Reports to Manager **Key Roles/Responsibilities** - End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to...

  • Senior Specialist, BT Pharmacovigilance

    1 week ago

    Mumbai, India Organon Full time

    This job is with Organon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Job Description The Position The Senior Specialist, BT Pharmacovigilance will report directly to the Director of Pharmacovigilance Business Technology and will be a key member...

  • Executive - Pharmacovigilance

    2 weeks ago

    Mumbai, Maharashtra, India Piramal Enterprises Full time

    Business: Critical Care Department: Pharmacovigilance Location: Kurla, Mumbai Travel: No **Reporting Structure** Reports to Manager **Key Roles/Responsibilities** - End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to...

  • Senior Specialist, BT Pharmacovigilance

    2 weeks ago

    Mumbai, Maharashtra, India Organon Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Job DescriptionThe PositionThe Senior Specialist, BT Pharmacovigilance will report directly to the Director of Pharmacovigilance Business Technology and will be a key member of the R&D Business Technology Services team.This individual is responsible for providing support and business/technical analysis efforts for the Pharmacovigilance systems, including...

  • We Are Hiring Pharmacovigilance Associate For Mnc Pharmaceutical At Mumbai

    6 days ago

    Mumbai, Maharashtra, India Talisman HR Solutions Full time

    Designation Pharmacovigilance Associate Education M pharmacy Experience Fresher or experience Pharma Industry Salary Best in industry Job Location BKC Mumbai Note This role will be on payroll of Talisman HR Solution Core Job Responsibilities Assist ASR in conducting Basic PV Training of company staff i e by assigning training and tracking compliance Send...

  • Regulatory Affairs Officer

    6 days ago

    Andheri West, Mumbai, Maharashtra, India Oxford Laboratories Pvt Ltd Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Oxford currently Looking for – Regulatory Affairs Officer for Mumbai H.Q.Roles and Responsibilities:The Regulatory Affairs Officer will provide support to the Regulatory Affairs Manager and assist in -Independent preparation of CTD dossier along with complete regulatory compilation like Notarized / Apostle documents, registration samples etc. for timely...

  • Safety Science Coordinator I

    1 week ago

    Mumbai, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Job-Clinical research coordinator-reputed clinical research company-Mumbai, Maharshtra, INDIA-upto 3 LPA-Chitra

    1 week ago

    Mumbai, India Seven Consultancy Full time

    JOB DETAILS One of our clients, a reputed company in clinical research, is looking out for a Clinical Research Coordinator for their office based in Mumbai. The job responsibilities are as follows: 1. Maintaining the source documents, CRF s, Investigator Site File and other study related documents according to ICH -GCP guidelines 2. Completing the eCRF 3....

  • Patient Care Coordinator

    7 days ago

    Mumbai, Maharashtra, India Axios International Full time

    **Position: Patient Care Coordinator - Mumbai** **Position Purpose** The jobholder is required to help represent Axios in daily meetings with patients, doctors and carry out administrative duties which will be both field and office based **Duties and Responsibilities** - Liaise with hospitals, distributors, pharmacies and patients - Co-payment reimburse...

  • Manager, Materiovigilance

    19 hours ago

    Mumbai, Maharashtra, India Bausch & Lomb Full time US$ 60,000 - US$ 1,20,000 per year

    Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.Our comprehensive portfolio of over 400 products is fully...