Author and reviewer of PSUR, PBRERs, ACOs.Involved in the generation of RMPs and signal detection reportsTo generate and review the line listings And summary tabulations To generate responses to health authority requestsInvolved in the preparation and revision of SOPsTraining and mentoring of new joinees on processes

To author, review and independently manage high quality clinical and safety documents. Deliverables include:o Periodic Safety Update Reports (PSUR) o Periodic Benefit Risk Evaluation Report (PBRER)o Development Safety Update Reports (DSUR)o Medical Impact analysis (MIA)o Clinical Trial Registry Database (CTRD)o Risk management Plans (RMP)o Addendum to clinical overviews reportso Periodic adverse drug experience reports (PADERs)o Patient… Show more To author, review and independently manage high quality clinical and safety documents. Deliverables include:o Periodic Safety Update Reports (PSUR) o Periodic Benefit Risk Evaluation Report (PBRER)o Development Safety Update Reports (DSUR)o Medical Impact analysis (MIA)o Clinical Trial Registry Database (CTRD)o Risk management Plans (RMP)o Addendum to clinical overviews reportso Periodic adverse drug experience reports (PADERs)o Patient NarrativesResponsible for integrating workflows across global sites for these deliverablesQC and review of the line listingsResponsible for overall quality management and complianceCoordination with the global clinical and safety teams while working on various projects Ensuring timely movement of project work through the process steps in accordance to governing SOP's, work instructions.Coordination with PVDM team for the generation of the listings and corrections in the listingsDelivery of high quality clinical and safety documents in time and in compliance with internal and external standardsLead for outsourced Narrative projects. Active interactions with clients on weekly basis for resolutions to their queries or any other questions.Actively participate in planning of data analyses and presentation to be used in CSRs.Developed shells for CSRs.Support the development of OSM through participating in OSM initiatives and related activitiesContribute to development of processes within OSMFostering cross functional communication to optimize feed-back and input towards high quality documentsMentor and coach for the newly joined writerMaintain audit, SOP and training compliance Show less

• Write various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including  Pharmacovigilance benefit and risk evaluation reports (PBRERs) Periodic Safety Update Reports (PSURs)  Periodic Adverse Drug Experience Reports (PADERs) Bridging reports Addendum Reports Canadian Annual Reports (CARs) Annual Reports (IND and other)• Peer reviewer of Canadian annual reports (CARs) and Non–EU… Show more • Write various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including  Pharmacovigilance benefit and risk evaluation reports (PBRERs) Periodic Safety Update Reports (PSURs)  Periodic Adverse Drug Experience Reports (PADERs) Bridging reports Addendum Reports Canadian Annual Reports (CARs) Annual Reports (IND and other)• Peer reviewer of Canadian annual reports (CARs) and Non–EU PSURs.• Literature searches using various databases like Ovid, Pubmed, Micromedex etc and screening out the valid safety reports.• Reviews narratives• Generation of listings from ARGUS and AERS databases.• Assist in writing Clinical Study Reports for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses• Assist in writing NCOs, COs, Medical queries.• Client interaction • Conducted trainings and mentored new joinees and other team members.• Created various trackers to improve the work efficiency• Well versed with the new EU good pharmacovigilance regulations Show less

• Presently handling the Oracle ARGUS Safety Database 6.0 (at Panacea Biotec Ltd).• Execute Installation Qualification checklists in accordance with accepted validation standards• Execute Operational Qualification scripts in accordance with accepted validation standards• Execute Performance Qualification scripts in accordance with accepted validation standards• Complete all checklist, test script, and/or error documentation according to document instructions and relevant SOPs… Show more • Presently handling the Oracle ARGUS Safety Database 6.0 (at Panacea Biotec Ltd).• Execute Installation Qualification checklists in accordance with accepted validation standards• Execute Operational Qualification scripts in accordance with accepted validation standards• Execute Performance Qualification scripts in accordance with accepted validation standards• Complete all checklist, test script, and/or error documentation according to document instructions and relevant SOPs, including all supporting materials such as screen shots, log files, etc. • To do literature search and screen out the valid case reports from databases like PubMED, Reactions Weekly etc.• Generation of Appendix XI schedule Y for the SAEs reported from clinical trials and reported to DCGI.• Peer review of all the Adverse Events (AEs/SAE) reports from different sources.• Evaluate and analyse AEs for its seriousness, causality and labelling as per CDS.• Develop a medically precise and succinct narrative.• To write case comments.• Medical review of non-serious cases• Conducts follow-up querying with reporter to clarify data for accuracy as well as capture additional relevant data• Involved in the distribution and reporting of ICSRs for reporting to authorities.• To handle Product quality complaints• Handling customer complaints and product quality complaints. • Follow procedures for supporting activities, such as requesting deletions, CAPA, etc.• Develop Standard Operating Procedures (SOPs) & other Pharmacovigilance documents as global Pharmacovigilance requirement.• Develop Aggregate safety reports (PSURs, Simplified PSURs etc) • To generate line listings and summary tabulations from the Argus Safety Database.• Well versed with the regulations of India (Schedule Y), EU (Vol 9), US Show less

Literature surveillance of assigned molecules.Data entry of AE/SAEs Adverse Events (AEs/SAE) reports including reports from Clinical Trials, Post Marketing Surveillance or Spontaneous Reports in safety database Argus 6.0 for all Panacea Biotec products.Thorough knowledge of Guidance documents like Vol 9a, ICH guidelines and US-FDA guidelinesAssisted in the generation of PSURs.