Accenture Job opening for Pharmacovigilance Services Specialist – Apply Now

Skill required: Pharmacovigilance Services – Pharmacovigilance & Drug Safety Surveillance
Designation: Pharmacovigilance Services Specialist
Qualifications:Any Graduation
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 Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 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? • Responsible for leading and authoring of the risk management and related activities within the agreed timeframes and accuracy, in compliance with Client’s (CLIENT) business rules, standard operating procedures (SOP) and global regulatory requirements, all as documented in CLIENT Quality documents as applicable. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements.
What are we looking for? o Minimum Education requirement: Degree in Life Sciences or Healthcare degree. o Work experience requirement: Around 2 to 3 years of experience in authoring/review of RMP documents.
Roles and Responsibilities: o Prepare and review risk management plan (RMP) and any adhoc reports requested by CLIENT. o Planning of pharmacovigilance activities to characterize and quantify chemically relevant risk and to identify new adverse reactions. o Planning and implementation of risk minimization measures, including the evaluation of the effectiveness of these activities. o Facilitate and conduct safety review meeting as and when required, and liaise with risk minimization physician on new RMP request or update to existing RMP based on health authority request, update in safety profile or any other reason. o If applicable, screening of literature for new and significant information that impacts the safety profile and risk benefit balance of assigned medicinal products and share with the relevant stakeholders. o Conduct or attend and contribute, to a kick-off meeting and/or regular teleconferences with CLIENT during the preparation of RMP. o Liaise with relevant internal and CLIENT stakeholders for the inputs required for RMP. o Complete all the sections of RMP as per CLIENT SOPs and guidelines and as agreed during kick-off meeting. o Perform activities as lead author and prepare submission ready draft of RMP. o Perform QC of the assigned draft RMP, per scorecard agreed with CLIENT, and provide feedback to the responsible author with the duly filled scorecard defect tracker. o Review source documentation provided by CLIENT for completeness and accuracy. o Facilitate stakeholders review as defined by the CLIENT. o Shall address all the comments received from all the stakeholders including review comments and provide the respective final versions of the reports to the CLIENT ready for publishing. o On-time escalation of any delayed inputs. o Support in implementation of additional risk minimization measures and effectiveness check as per the requirement.