Pharmacovigilance Manager

About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit hcltech.com. Website - http://www.hcltech.com

Job Responsibilities:

• Includes all or majority of the following below.
• Other duties may be assigned as dictated by PV business needs.
• Assist with the preparation of project plans as required
• Alert Program Manager when activities fall outside SOW
• Process and evaluate AE reports according to the customers standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment
• Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings.
• Preparation of training materials specific to safety, participate and/or lead training sessions.
• Assist in the reconciliation of clinical and safety databases.
• Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment.
• Perform literature review for identification of case reports and other relevant safety
• Review/Quality Check (QC) of source documents, coding, data entry , report generation and distribution.
• Assist in evaluation and validation of systems to support safety.
• Perform triage of cases prior to case processing.
• Mentor, train, and update of new and existing staff on clients.
• Inform appropriate Telerx staff of delayed, missing or incomplete items; ensure follow-up and completion of all transactions are performed in a timely manner.
• Utilize Medical Review staff of issues to assure patient safety, manage client risk, understand and manage salient clinical/medical issues, adjudicate and reconcile conflicting or difficult clinical issues.
• Minimize Telerx risk and collaborate with Quality Standards to assure regulatory compliance.
• Communicate key issues and milestones, and facilitate Telerx management of client expectations.
• Partner in new client implementations and client meetings and preparation of meeting agendas and minutes.as required.
• Ensure that all internal and client-specific activities are performed in compliance with appropriate Regulatory requirements.
• Participate in quality assessment reviews and audits
• Function in the Deputy Qualified Person for Pharmacovigilance (deputy QPPV) role as appropriate
• Function in the Responsible Person (RP)/backup Responsible Person role as appropriate
• Review European Medicines Agency (EMA) guidelines and respective requirements for registration and maintenance of profiles/users in Eudra Vigilance (EV)
• Provide guidance to Client for RP/QPPV requirements in relation to EV
• Lead the collection of all required documentation to complete his/her and the company registration with the (EMA)
• Submit documentation to EV o Register the Client (if applicable)
• Approve and grant access for the EV users of the Client o Ensure that a sufficient number of EV users is active for the organization
• Deactivate EV access for users who are no longer involved in the Program
• Participate in development of a program specific plan which contains provisions for EV profile management in compliance with current European Union (EU) legislation and guidelines
• Ensure availability of a Trusted Deputy (back up for RP/QPPV)
• Function as the PV Data Protection Officer (DPO) as appropriate
• Provide sustainable support to Global Privacy Office (‘GPO’) on behalf of PV for various aspects of the privacy program such as privacy baseline controls implementation, privacy impact assessment program, privacy incident management, and data subject rights management
• Foster high level of knowledge of basic privacy / data protection fundamentals within 1st -line-of defense and impart technical expertise to stakeholders
• Expand reach of Global Privacy Office (‘GPO’) within the organization
• Continuous oversight of privacy program
• Facilitate accurate evaluation of privacy risks via authentic first-hand information from resources processing/handling safety data.
• Devise effective risk remediation strategies, well-suited to the data processing environment
• Timely escalation of requisite privacy risks.
• Proliferation of the corporate privacy and data protection training program
• Education of key stakeholders (within delivery/enabling function) concerning privacy risk identification and its mitigation .
• Gain strategic insights into delivery / enabling functions for enhancing existing privacy projects and identifying any new project with organization-wide impact or with a certain geographic specific impact
• Coordinate with respective business engagement / corporate functions on matters relating to privacy / data protection.
• These matters may include, but not stay limited to, risk management activities pertaining to the collection, handling, processing, storage, retention and disposal of personally identifiable information (“PII”) / personal data across globe.