Safety & Pv Trainee L Only For Delhi Ncr Freshers

Updated Yesterday Location Gurgaon HR India Job ID 25102900 Description Safety PV Trainee l Only for Delhi NCR Freshers Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment youa ll collaborate with passionate problem solvers innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives Discover what our 29 000 employees across 110 countries already know WORK HERE MATTERS EVERYWHERE 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 our Total Self culture a where you can authentically be yourself Our Total Self culture is what unites us globally and we are dedicated to taking care of our people We are continuously building the company we all want to work for and our customers want to work with Why Because when we bring together diversity of thoughts backgrounds cultures and perspectives a wea re able to create a place where everyone feels like they belong Job Responsibilities -Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assists in the processing of ICSRs according to Standard Operating Procedures SOPs and project program-specific safety plans as required - Triages ICSRs evaluates ICSR data for completeness accuracy and regulatory report ability - Enters data into safety database - Codes events medical history concomitant medications and tests - Compiles complete narrative summaries - Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved - Assists in the generation of timely consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements - Maintains safety tracking for assigned activities - Performs literature screening and review for safety drug coding maintenance of drug dictionary MedDRA coding as required - Validation and Submission of xEVMPD product records including appropriate coding of indication terms using MedDRA - Manual recoding of un-recoded product and substance terms arises from ICSRs - Identification and management of duplicate ICSRs - Activities related to SPOR IDMP - Quality review of ICSRs - Ensures 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 appropriate - Maintains understanding and compliance with SOPs Work Instructions WIs global drug biologic device regulations GCP ICH guidelines GVP project program plans and the drug development process - Fosters constructive and professional working relationships with all project team members internal and external - Participates in audits as required appropriate - Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities Qualification Requirements - Education Eligibility Required M Pharm Pharm D M Sc B Pharm BHMS BDS or Ph D Pharmacy passed out in the year 2025 Core Skills Required Strong knowledge and interest in a healthcare scientific background is a must Proficiency in Microsoft Office Suite and Outlook Strong organizational documentation and multitasking skills Excellent written and verbal communication Ability to collaborate effectively in a team environment High attention to detail and accuracy Preferred Qualifications Familiarity with safety databases medical terminology pharmacology or pharmacovigilance Experience with collaboration tools Visio Team Share or equivalent Important Note - This is a contractual role for a period of 1 year with continuation subject to performance evaluation and business needs Get to know Syneos Health Over the past 5 years we have worked with 94 of all Novel FDA Approved Drugs 95 of EMA Authorized Products and over 200 Studies across 73 000 Sites and 675 000 Trial patients No matter what your role is youa ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health Additional Information Tasks duties and responsibilities as listed in this job description are not exhaustive The Company at its sole discretion and with no prior notice may assign other tasks duties and job responsibilities Equivalent experience skills and or education will also be considered so qualifications of incumbents may differ from those listed in the The Company at its sole discretion will determine what constitutes as equivalent to the qualifications described above Further nothing contained herein should be construed to create an employment contract Occasionally required skills experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act including the provision of reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job Share this job