Pharmacovigilance Services Specialist

Skill required: Pharmacovigilance Operations - Safety Writing

Designation: Pharmacovigilance Services Specialist

Qualifications:Bachelor of Aryurvedic Medicine And Surgery/Bachelor Degree in Life Sciences/Master Degree in Life Sciences

Years of Experience:7 to 11 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Songall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do oResponsible for leading the Signal Management activities including weekly literature review, authoring of signal reports (Signal Management aid Review Team [SMART] reports) and project management of Safety Surveillance team (SST) meeting within the, agreed timeframes and accuracy, in compliance with business miles, standard operating procedures (SOP) and global regulatory requirements, all as documented ilil Quality documents as applicable.

What are we looking for EducationaloMinimum Education requirement:Degree in Life Sciences or Healthcare degreeExperience RequirementsoWork experience requirements:Minimum of 3 years of Aggregate report experience with 3 years of signal management process experienceoWorking knowledge of Good Clinical Data Management Practices, GVP (Good Pharmacovigilance Practices), ICH Good Clinical PracticesoExperience with MS Office productsoAbility to work independently under tight time constraintsoGood interpersonal skills and the ability to, operate effectively in an international environment

Roles and Responsibilities: o Literature review:On a weekly basis, review abstracts and articles for safety signals and/or for possible inclusion in the aggregate reports and record assessments in appropriate trackers. o Liaise with Global Safety Officer (GSO") Pharmacovigilance (PV) Scientist if a potential safety signal is identified upon review of the weekly alerts or in case of doubt. summary of articles of interest for GSO review with PV Scientist in copy in advance of the SMART meetings. o Complete the Literature Search Alert Tracker once GSO response received.o SMART Meeting:o Liaise with counterpart to identify the attendees and stakeholders for SMART meeting. o Schedule, SMART meetings and liaise with stakeholders and collate all the necessary data for review. o Draft the SMART report in the Electronic Data Management System (B-EAMS) using the applicable template. Compile and distribute the SMART report applicable stakeholders prior to, the SMART meeting. o Host the SMART meeting and document the review and any applicable action items in the SMART report. Update the SMART report and distribute it for review. Address the review comments and compile the draft for quality check. o Finalize the SMART report after addressing the QC comments and Route the final SMART report to GSO for approval. Enter information from the SMART meeting in the Safety Surveillance and Aggregate Reports (SSA) tracker.o SST Meetings:o Liaise with PV Scientist to debility the attendees and stakeholders for SST meeting. o Schedule the SST meetings and send Request for Information to the shareholders. To Compile the SST slide deck based on input from stakeholders, Prepare SST meeting minutes using the applicable template to document the action items discussed ilil the SST meeting. Distribute the minutes to stakeholders, finalize the minutes. Enter information from the SST meeting in the SSA tracker.oPerform the Signal management activities as per SOPs, Job Aids and guidelines as agreed during the SMART meetings and/or weekly team meetingoOn -time escalation of any delayed inputs/ review comments/ endorsement as per process.oArchive the supporting documents used to, prepare the aggregate reports in the SharePoint or electronic repository as per the defined timelinesoProvide responses to the query related to SMART reports as per the requested timelineoComplete the training as per the assigned timelineoWork with the IT systems where required (Tableau, BEAMS and SharePoint)
Qualification
Bachelor of Aryurvedic Medicine And Surgery,Bachelor Degree in Life Sciences,Master Degree in Life Sciences