Job title: Manager/ Sr. Manager- Pharmacovigilance
Company: Naman Staffing
Job description: Job Details Position: Manager/ Sr. Manager- Pharmacovigilance Job Location : Ahmedabad About the company : One of the leading names in pharmaceutical Sector Job Requirement : Any Graduate with 10+ Years of experience in Pharmacovigilance from pharmaceutical Sector. Job Role : Overall knowledge about Pharmacovigilance system functioning, conducting and supervising regular pharmacovigilance processes Collection, Processing and Reporting of Individual Case Safety Report that includes: Collection and verification of Individual Case Safety Report Case creation and data entry in safety Database Coding using MeDRA and WHO – DD Quality review Case Narrative Writing Generation of XML format Regulatory Submission Scientific and Medical literature search for safety information and reporting to regulatory: Worldwide literature search using various search engines Valid ICSRs shall be processed through safety database after quality review and medical review and regulatory submission within the stipulated time frames Knowledge about exclusion criteria for the submission of ICSRs published in the medical literature Preparation / review of Periodic Safety Update Report (PSUR) Preparation, Submission and Implementation of Risk Management Plans Signal Management includes: Signal Detection & Validation Signal Analysis and Prioritization Signal Assessment Recommendation for action Preparation / review of SDEA (Safety Data Exchange Agreement) for selected products Preparation of Pharmacovigilance Master File and regular updates Preparation of Pharmacovigilance Plan and regular updates Preparation / review and updates of SOPs Knowledge regarding various regulatory guidance and ensure compliance Periodic review of the database for potential safety issues Support the setup and implementation of pharmacovigilance activities for research studies at both local and central level, including staff training Contact Person: Sarita Chaudhary Email: sarita@namanstaffing.com Interested candidates can directly APPLY on the below link
Expected salary:
Location: Ahmedabad, Gujarat
Job date: Thu, 15 Sep 2022 02:19:06 GMT
Apply for the job now!