Safety & PV Specialist (SS I / SS II / Sr SS) - Night Shift

Safety & PV Specialist (SS I / SS II / Sr SS) - Night Shift 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.   Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. 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 – 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 – we’re able to create a place where everyone feels like they belong.  Job Responsibilities - Must have 6 + yrs of experience in ICSR case processing and Quality Check / Quality Review. - Applicants should be willing to work in night shift. - The work location is Hyderabad / Gurugram, candidate should be willing to work at Hyderabad / Gurugram office. - 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.

Education: B. Pharm / M. Pharm / BDS / BMS / MBBS (No BSc / MSc) Location: Gurugram-Hyderabad/Pune Office based Skill for Sr Safety & PV Specialist​ : ICSR case processing experience along with Quality Check (QC) Experience is mandatory Experience-   Sr Safety & PV Specialist-