Pharmacovigilance Services Manager

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance


Designation: Pharmacovigilance Services Manager


Qualifications:MSc/Master of Pharmacy


Years of Experience:13 to 18 years


What would you do?
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.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?
Creation and Implementation of Portfolio Quality Management framework for LSR & D engagement.Establish quality and compliance activities for existing and new scope of services.Lead and act as the point of contact for client audits and inspections by regulatoryauthoritiesLead/contribute to the creation of formal processes; review and approve them asapplicable.Assume overall document management responsibility for the assigned project.Ensure data security/privacy measures are implemented in deal teams, by the deliveryleads and deal representatives.Lead Quality Governance meetings with clients where quality and compliance metrics areshared and discussed. Assign action items from these meetings to relevant SMEs andtrack them to completion.Ensure deviations and CAPAs are managed effectively and closed on time.Closely monitor and contribute to contract updates, subsequent changes required in theprocesses and monitor their completion.Focus on the standardization of processes and systems across all project locations.Lead the execution of all Audit/Inspection recommendations and findings in a timelymanner and store objective evidence of completion of associated actions.

Roles and Responsibilities: Creation and Implementation of Portfolio Quality Management framework for LSR & D engagement.Establish quality and compliance activities for existing and new scope of services.Lead and act as the point of contact for client audits and inspections by regulatoryauthoritiesLead/contribute to the creation of formal processes; review and approve them asapplicable.Assume overall document management responsibility for the assigned project.Ensure data security/privacy measures are implemented in deal teams, by the deliveryleads and deal representatives.Lead Quality Governance meetings with clients where quality and compliance metrics areshared and discussed. Assign action items from these meetings to relevant SMEs andtrack them to completion.Ensure deviations and CAPAs are managed effectively and closed on time.Closely monitor and contribute to contract updates, subsequent changes required in theprocesses and monitor their completion.Focus on the standardization of processes and systems across all project locations.Lead the execution of all Audit/Inspection recommendations and findings in a timelymanner and store objective evidence of completion of associated actions.Develop and lead the exection of deliverables in the Quality Management Plan forspecific PV engagement in compliance with the contract for Accenture.Identify specific role-based training requirements and ensure the engagement teamcompletes all deal and GxP related trainings in a timely manner.Provide periodic updates to clients (metrics delivery) and run the framework ofcontinuous improvement.Monitor performance of team and resolve any conflicts that may arise within the team.Undertake additional responsibilities as and when required by the management.

 
Qualifications 
MSc,Master of Pharmacy