Aggregate Report Writer

Primary ResponsibilitiesFunction as primary point of contact for each group of therapeutic areas.Lead/Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements.Support roles involved in creation of Aggregate Safety Reports (ASRs) (i.e., PSURs, PADER, DSURs, PBRER’s, Addendum to Clinical Overview’s, Addendum to PSUR’s, Summary Bridging Report’s and RMP Updates), signal validation and evaluation report.Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template.Creation and review of PSMF, Periodic review of PSMFParticipate in signal detection and management activities involving detection, validation and evaluation and prioritization. Compile the safety data into the relevant sections of periodic reports such as PBRER, PSUR, AdCO, PADER, and DSUR according to the client.Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal detection.Ensure that narrative writing/safety report drafting, follow-up activities and all documentation are conducted per client approved project SOP, WI, convention and workflow in collaboration with quality assurance.Plan, organize, and manage daily work to meet service level timelines and deliverables.Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.Provide word and PDF versions of the final signed documents to the client.Participate in internal and external audits and inspections by clients and health authorities.Ensure adequate and appropriate training and training documentation.Cross check RMPs as required to draft aggregate reports.Ensure appropriate and adequate resource allocation and back-up roles for project continuity and timely delivery.Quality delivery through a rigorous metrics-based approach.Ensure timeline are being met.Perform any other drug safety related activities as assigned.Secondary ResponsibilitiesMaintain quality service and departmental standards by:Reading, understanding, and adhering to organizational standard operating procedures (SOPs)Assisting in establishing and enforcing departmental standardsContribute to team effort by:Working with internal staff to resolve issuesExploring new opportunities to add value to organization and departmental processesHelping others to achieve resultsPerforming other duties as assignedMaintain technical and industry knowledge by:Attending and participating in applicable company-sponsored trainingQualificationsEducation: Any Healthcare professional (B Pharm/M Pharm/Pharm D/BDS/Nursing or any other equivalent qualification)Experience: 5-7 years of experience in Pharmacovigilance / Pharmaceutical / Clinical researchAdditional SkillsStrong motivational skills and abilities, promoting a team-based approachStrong interpersonal and communication skills, both verbal and written in EnglishStrong organizational and leadership skillsGoal-orientedAbility to maintain professional and positive attitude