Safety Aggregate Reporting Manager

IQVIA; Thane; On-site; INR 900,000 - 1,300,000; Full time

Job summary

IQVIA is seeking a Safety Aggregate Reporting Manager to lead signal detection and literature surveillance for marketed and investigational products. You will author and finalize aggregate safety reports (PBRERs/PSURs/DSURs/ACOs) and respond to regulatory inquiries, while mentoring project teams and ensuring KPI-driven performance.

As a molecule lead, you will set up signaling strategies, oversee documentation, and coordinate with cross-functional stakeholders to deliver deliverables on time.

Qualifications

• Life science graduate or post-graduate or healthcare qualification.
• 5–10 years of pharmacovigilance experience with drug safety and aggregate reporting.
• Excellent communication skills, both written and verbal.
• Strong organizational and time management abilities.
• Fluent in English (spoken and written).

Responsibilities

• Lead signal detection activities and literature surveillance for marketed and investigational products.
• Author and finalize aggregate reports (e.g., PBRERs/PSURs/DSURs) and respond to regulatory inquiries.
• Serve as molecule lead and ensure on-time delivery with KPI compliance.
• Set up and update product signaling strategies with Safety Strategy Lead approval.
• Mentor and coach project team staff; manage line reports and line management duties.
• Participate in audits/inspections and drive process improvements.

Skills

Communication

Organization

Time management

Deadline-driven

Prioritization

English fluency

Education

Life science degree / healthcare qualification

Job description

Safety Aggregate Rptg, Mgr, Duties/Responsibilities: Act as signal detection and literature lead, or back-up lead to contribute to the conduct of ongoing literature safety surveillance for marketed and investigational products, evaluating events of special interests as well as aggregate data review Author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs and ACOs. Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Can serve as principal owner (molecule lead) for the molecule and have responsibility for completion of the deliverable and in compliance with all applicable Key performance indicators (KPI); Set-up and update products' signaling strategies, as approved by the customer’s Safety Strategy Lead. 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, as approved by the customer’s Safety Strategy Lead. Responsible for full documentation and tracking of signals. Ensuring the completion of molecule deliverables on time and liaise with portfolio clinical science scientists, service provider process leads and cross-functional stakeholders. Accountable for full documentation and tracking of assigned activities. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections. Proactively identify issues and propose solutions. Can act as mentor to and coach to project team staff and direct line reports. Lead functional team and contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Contribute and assist in global/local working groups as applicable in implementation of new operational initiatives, identification and implementation of process efficiencies Can be a line manager and would be responsible for all IQVIA line management activities. Collaborate with line managers to resolve project performance-related issues for staff. End-to-end molecule work oversight and responsibility (i.e., ensuring consistent tracking of signals from detection to assessment to inclusion in aggregate reports). Ensuring an in-depth knowledge of the molecule and disease area within the service provider molecule team. Oversight and responsibility of quality-of molecule deliverables to the customer’s molecule team, with “hands-on” involvement, i.e., involved in authoring DSR conclusion, participating in SD/Lit meetings between service provider and customers. Responsible for resolution of issues on molecule deliverables (if necessary, in collaboration with service provider process lead). Participate in internal and external audits and inspections, as required. 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 to maintain compliance and documented Conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.

Qualifications:

• Life science graduate/post-graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• 5-10 years of relevant experience in Pharmacovigilance including hands-on experience of drug safety, aggregate reports, signal detection/signal management preferred
• Excellent communication (written and verbal) skills
• Strong organizational and time management skills.
• Proven ability to meet strict deadlines.
• Manage competing priorities and ability to be flexible and receptive to changing demands
• English – fluent (spoken, written)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Experience Level Senior Level