Manager, Global Safety and Pharmacovigilance, 6 - 10 years exp, Pune

Please enter your email ID to get job alerts Thank you for your feedback. This will help us improve the quality of jobs that are available on naukri.com for you. inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing. Designation Manager, Global Safety and Pharmacovigilance Job Description Provide day to day managerial oversight to the Pharmacovigilance staff Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements Prepare and/or review expedited Safety Reports for submission to Regulatory Authorities Communicate with Clinical Research and clients to ensure compliance with drug safety and Pharmacovigilance SOPs Be the safety lead for projects; to include set-up, project management client liaison Mentor Safety Associates and other members of the Global Safety and Pharmacovigilance group involved in safety data processing Perform training of safety reporting requirements for other PharmaNet departments. Be responsible for SAE reconciliation for a study Ensure that PharmaNet is in compliance with safety reporting requirements of regulatory authorities Ensure that PharmaNet meets client expectations and requirements for safety reporting Provide regulatory consultation regarding safety reporting for investigational drugs Review serious adverse experience information received form investigative sites and assures compliance with reporting requirements Prepare/review safety section of regulatory reports, e.g. Annual Reports and Periodic Safety Update Reports Prepare SAE reporting plans Represent Global Safety and Pharmacovigilance group at project team, client and Investigator meetings Prepare documents describing the process for monitoring and reporting serious adverse experience (e.g., SOP, user manuals) Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations relating to safety reporting Coordinate with Medical Affairs, Clinical Research and Data Management for the efficient and timely review of safety information at PharmaNet Assist Business Development for client development presentations that involve safety reporting as a potential service: provide adequate input into client proposals Act as project manager for stand-alone Safety and Pharmacovigilance projects Desired Profile Bachelors Degree in a life science or nursing; or RN diploma Six years relevant experience in Safety/Pharmacovigilance required which may include up to 2 years of data management, CRA, clinical practice (RN, RPN). Health authority of study coordinator experience Good Verbal and written communication skills Excellent Knowledge of ICH guidelines and regulation relating to Pharmacovigilance Demonstrate working knowledge in MS Office applications Ability and willingness to travel (20%) Experience 6 - 10 Years Industry Type Pharma / Biotech / Clinical Research Role Other Functional Area Other Education UG - Any Graduate - Any Specialization, Graduation Not Required PG - Any Postgraduate - Any Specialization, Post Graduation Not Required DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required Location Pune Keywords Manager, Drug Safety, Pharmacovigilance, ARGUS, ARIS, Team Lead, Safety Reports, Safety Associate, Case Processing Contact Venkata Pradeep inVentiv International Pharma Services Pvt Ltd Job Posted 15 May

Categories: Others job