Associate Director, Pharmacovigilance Scientist

remotepromsp; India; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

reputed company Co., Ltd. is a global pharmaceutical company seeking a Pharmacovigilance and Risk Management Associate Director to lead safety governance and cross-functional safety activities.

This role focuses on signal detection, risk assessment, and collaboration with Clinical Development, Regulatory Affairs, and other functions to ensure patient safety. The position reports to the Director of Pharmacovigilance and Risk Management and requires strong leadership in safety governance and

Qualifications

• Experience in pharmacovigilance safety governance.
• Ability to lead safety teams and collaborate with multiple departments.
• Experience with adverse event reporting and regulatory requests.

Responsibilities

• Leads/contributes to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information through established safety governance.
• Maintains safety monitoring for investigational and marketed products and ongoing risk/benefit assessment.
• Represents PVRM in cross-functional Steering Committee meetings and partner meetings.
• Performs review of adverse event reports, including serious events, ensuring quality of assessment.
• Provides input to safety documents and risk mitigation strategies as appropriate.

Skills

Pharmacovigilance

Safety governance

Cross-functional collaboration

Signal detection

Regulatory compliance

Job description

reputed company Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (reputed company.), reputed company on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website The Pharmacovigilance and Risk Management (PVRM) Associate Director serves as the PVRM reputed company of contact for cross-functional, global development, and strategic partnership co-development teams while leading safety surveillance activities, including signal detection, evaluation, and risk management activities and ensuring adherence to safety governance for assigned compounds/products. This role will report to the Director, Pharmacovigilance and Risk Management (PVRM).

Job Duties and Responsibilities

• Supports Drug Safety Physicians Safety Governance efforts by leading cross-functional Safety Management Team (SMT) assessing drug safety reputed company and providing safety guidance and input to key safety documents, including IBs, ICFs, protocols, study reports, regulatory reports, and responses to regulatory requests.
• Leads/contributes to signal detection, monitoring, evaluation, interpretation, escalation, and appropriate communication of safety information through established safety governance.
• Maintains reputed company monitoring and updates of safety reputed company for assigned investigational and marketed products and ongoing risk/benefit assessment for investigational/marketed products.
• Serves as reputed company of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other reputed company departments.
• Represent PVRM at cross-functional Steering Committee meetings or corporate partner-reputed company meetings -Joint Safety Forums (JSFs) and PVC.
• Performs Review of adverse event reports, including but not limited to reputed company serious events of interest, and expedited individual case safety reports, ensuring that appropriate interpretation, consistency, and quality are applied to adverse event case assessment on individual and aggregate reputed company.
• Generates or assists with input to Analysis of Similar Events, if required.
• Performs review of coding (e.g., reaction, suspect/concomitant product, indication, laboratory data, medical history).
• Provides support for investigator brochures, protocols, informed consent, final study reports, and other safety-relevant documents as appropriate.
• Leads early identification of safety issues that require Safety Governance escalation from Safety Management Teams (SMTs) to Therapeutic Area Safety Committees (TASCs) and/or the Executive Safety Committee (ESC).
• Serves as SMT Chair/reputed company member for assigned products.
• Serves as subject matter expert in study protocol design, review of interim reports for ongoing clinical trials, clinical study reports, safety summary documents, and responses to regulatory requests.
• Prepares and may present individual case safety report issues, aggregate data analyses and interpretation, strategies for submission documents such as the ISS and SCS, and proposed risk mitigation strategies for discussion at internal meetings.
• Provides input to key internal safety documents, including Risk Management documents (REMS, RMPs), development, and updates/maintenance of expectedness guides.
• Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety.
• Review Literature search reputed company and reputed company literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities.
• Participate in aggregate safety report activities, including data compilation and analysis, as reputed company as the writing of assigned sections (with vendor support).
• Coordinate responses to reputed company safety issues such as regulatory authority, site, or health care professional requests.
• Serve as a subject matter expert in PVRM reputed company the assigned program(s) as reputed company as the larger SMPA organization (R&D and reputed company).
• Other Activities may include, as requested: reputed company Standard Operating Procedures, Work Instructions, and other controlled documents.
• Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities.
• Support collaboration with external partners.
• Supports PVRM or cross-functional reputed company projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of Patient First in line with SMPAs values and reputed company behaviors.