Senior Safety & PV submission Specialist (Gurugram/Hyderabad)

Senior Safety & PV submission Specialist (Gurugram/Hyderabad)Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to building an inclusive culture where you can authentically be yourself. Central to this is our purpose Driven to Deliver which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someones life.We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Collaborate with the Sponsor and internal project management associates on the design, preparation and assembly of the expedited and periodic safety report documentsParticipates in project launch activities for safety reporting tasksPrepares Safety Reporting Plan for safety submissions only projectsMaintain tracking of safety submissionsProvides Sponsor/Customer with expedited and periodic safety report submission status updates, as requiredProvides support and advice on expedited and periodic safety report issues to project team/Sponsor as requiredApply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activitiesFile documents according to project specific requirements (electronically or in hard copy as applicable).Forward completed safety submission documents to clients and other relevant partiesActs as a point of contact for regulatory issues related to safety submissionsMay be responsible for distributing and monitoring team workloadFosters constructive and professional working relationships with all project team members, internal and externalAssists in the preparation and participates in internal project review meetings as requiredAssists in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs), related to submissions.Participates in audits as required/appropriateEnsures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post marketing programs as appropriateMaintains an understanding and compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.What We're looking for: Bachelors Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.Experience in a clinical research organization preferred with a minimum of 6 years' Safety and Pharmacovigilance experience required including safety submissions Experience in Safety Submissions to regulatoty authorities (Ideal) sites and Ethics committeeExperience in leading projects for safety submissions workTMF Filing and oversight Thorough knowledge on PV guidelines, EMEA,FDA and India guidelinesSafety Database systems experience and knowledge of medical terminology required In depth understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio .