2 Signal Management Jobs

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

Role & responsibilities To prepare and review and reporting of aggregate reports (PADERs and PBRERS/PSURs), signal reports, risk management plan reports. To oversee the assignment of activities within the team and ensure the timely delivery and appropriate quality oversight of aggregate reports. Ensure tasks are performed as per applicable procedures (e.g., WI, SOPs) assigned to the role. To provide response to the regulatory queries on safety topics and relevant documents in support to content of safety. To liaise with cross-functional departments such as Regulatory Affairs and Medical Review to ensure seamless coordination of safety-related activities. To establish and maintain effective communication with country-specific pharmacovigilance contacts to support global reporting obligations. Support internal and external audits by providing accurate and timely safety documentation and regulatory compliance records. Interested Candidates please send me resumes to sravana.a@hetero.com