Job Title - Safety Aggregate Report Specialist 2.

Skills required - Signal detection/Signal Management.

Years of exp required - 4+ yrs exp in Signal Mgt.

Work location - Anywhere in India.

Work Mode - Hybrid/Remote.

Job Overview.

Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.

• 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 characterization 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. investigators, medical monitors, site coordinators and designees to address project related issues.

• Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes.

• To liaise with client in relation to details on day to day activities as needed.

• Contribute to achievement of departmental goals

• Perform other duties as assigned

Safety Aggregate Report Specialist 2 (Signal Management)