Establish and maintain the pharmacovigilance system master file (PSMF) with the legal requirements and verify that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system. Ensuring the conduct of pharmacovigilance and submission of all pharmacov...
Act as Deputy QPPV for global pharmacovigilance, pharmacovigilance officer in-charge (PvOI) and also as a point of contact (24 hours) for regulatory agencies in the absence of QPPV. Establish and maintain the pharmacovigilance system master file (PSMF) with the legal requirements and verify that the...
Establish and maintain the pharmacovigilance system master file (PSMF) with the legal requirements and verify that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system. Ensuring the conduct of pharmacovigilance and submission of all pharmacov...
Lead end-to-end global pharmacovigilance systems and management as per regulatory requirementsAct as Deputy QPPV for global pharmacovigilance, pharmacovigilance officer in-charge (PvOI) and also as a point of contact (24 hours) for regulatory agencies in the absence of QPPV. Establish and maintain t...
Drug Safety Physician - Pharmacovigilance. Drug Safety Physician - Pharmacovigilance. Candidates with experience in Pharmacovigilance ICSR Review for minimum 1- 4 year. ...
This position is a member of Global Patient Safety – Pharmacovigilance Compliance and Safety Operations -PV Technology and Systems support team. This position is responsible for managing systems and databases to support consistent and accurate pharmacovigilance data collection, data analysis, report...
Medpace is a full-service clinical contract research organization (CRO).We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.Our mission is to accelerate the global development of safe and effective medical therapeutics through its sc...
With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profil...
Regional Pharmacovigilance Officer. The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise in case management and PV process management activities. Supporting local Pharmacovigilance Contract Management. Generating local...
Review and conduct medical assessment of Human and Veterinary Pharmacovigilance/ safety documents (including ICSRs and aggregate safety reports such as PADER/PSUR). Response to queries and requests related to safety of products and the pharmacovigilance system from internal and external stakeholders...
Required Knowledge, Skills and Abilities.Contract Research Organizations or Pharmaceutical companies....
Maintenance of project information or Pharmacovigilance intelligence information with timely updates to the project or intelligence databases. ...
Perform pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AE), determining event status, database entry, coding AE and products, and writing narratives. Experience with pharmacovigilance activities in clinical trials, including collecting and tracking incoming ...
Manager - Pharmacovigilance Department. ...
Pharmacovigilance, working on clinical studies and/or study safety methodology. ...
In these endeavors, CVIA works closely with international vaccine manufacturers from early development through post-marketing effectiveness and pharmacovigilance (PV) surveillance activities. The Pharmacovigilance Group in CVIA Clinical team, where the. The incumbent will support CVIA and its intern...
Location: Taloja, Navi MumbaiExperience: 2 yearsRequired skills: Pharmacovigilance knowledge Knowledge of CDSCO documentation Submitting documents on Sugam Portal Complaint handling along with PVJob Description:The position will be an Executive level. Main focus of the candidate will be handling Ph...
Drug Development domain - Pharmacovigilance and Safety is essential Would have used software solution as part of Pharmacovigilance and Safety experience Skills : (Technical Skill / Non Technical Skills) Excellent Communication skills Recent trends in domain Product Lifecycle Management process knowl...
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs,,Conduct/Lead ongoing literature safety surveillance for marketed and investigational products,Assist with the identification of ICSRs from literature, evaluation of events of special interests...
The Executive Pharmacovigilance will be responsible 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 applicable regulatory authorities within stipulated timelines. This ...
Date Posted:** February 23, 2022 - **Location:** Hyderabad - **Job Title:** Medical Monitor Clinical Trials & Pharmacovigilance - **Job ID:** JS-CT-563 Provide inputs on protocol preparation from clinical perspective, based on therapeutic area & study phasePrepare and Participate in Subject Expert ...
If youre as driven as we are join us.Youllbe working in a dynamic and supportive environment with some of thebrightest and the friendliest people in the sector and youll behelping shape an industry.Maintain acomprehensive understanding of ICON Standard Operating Procedures(SOPs) Working Procedures (...
Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. Pharmacovigilance Scientist opportunities in the. Bringing together more than 3...
Serve as Functional Lead on caseprocessing or medical information projects as assigned; coordinatesteams of Pharmacovigilance associates on project level and servesas the Pharmacovigilance point of contact for projectteams. Effectively coaches and mentors lessexperienced Pharmacovigilance associates...
Responsibilities** - Build and maintain a good relationship with clients such as pharmaceutical companies, etc.Win-Win situation for both the company and the client by providing satisfactory services that meet various requests and expectations.Conduct the following tasks to achieve the above: ...