Sr Safety & PV Specialist (Literature Case Processing & Review)

Job Responsibilities

Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.
Skilled in extracting and summarizing key safety information from identified literature sources Thorough understanding of creating and validating search strategies for pharmacovigilance purpose. In depth knowledge of major literature databases such as Embase, PubMed etc. Experience in conducting local literature searches and reviews. Understanding of regulatory requirements with respect to global and local literature.
Coordinating workflow to ensure delivery of project. Prepares Safety Management Plan. Assists in the preparation and participates in internal project review meetings as required. May enter information into PVG quality and tracking systems for receipt and tracking ICSR. May process ICSRs according to Standard Operating Procedures (SOPs) and project/program- specific safety plans. o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. o Enters data into safety database. o Codes events, medical history, concomitant medications and tests. o Compiles complete narrative summaries. o Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved. o Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements. o Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports. Provides training of Investigators on ICSR reporting Participate in audits/inspections as required 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, GCPs, ICH guidelines, GVP, project/program plans and the drug development process. Reviews and provides solutions for issues relating to program delivery or escalates appropriately to the Program Lead / Program Director as required Support identification and provides standards for gathering information for use in trend analysis Act as a subject matter expert and help the team members with day-to-day trouble shooting activities What we re looking for:
Educational Qulaification: B.Pharm/M.Pharm/PharmD/BDS/BMS

Minimum 5 Years of experience in Literature Case processing is required along with SME experience

Location: Gurugram/Hyderabad Office based role
Safety Database systems 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, email (Outlook), TeamShare (or other management/shared content/workspace) and internet. Ability to work independently and in a team environment Strong communication, presentation, interpersonal skills, both written and spoken Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects Detail oriented with a high degree of accuracy and ability to meet deadlines Able to make effective decisions Minimal travel may be required (up to 10%)