Job Description:
Position Overview
This position of Director Global Drug Safety and Pharmacovigilance (GDSPV) contributes to the Company's success in leading and providing direction for all product safety and pharmacovigilance activities in compliance with global pharmacovigilance and regulatory requirements. The incumbent serves as a safety liaison with the Company's cross-functional teams and is responsible for oversight, strategic planning, and execution of pharmacovigilance, drug safety, case management and inspection readiness for investigational and marketed products, while striving for operational excellence and ensuring Company license partner and vendor contractual obligations are maintained.
Summary of Key Responsibilities
• Contribute to the development of GDSPV Operation strategy, goals, and objectives and assist with the implementation and training to support department goals and initiatives.
• Manage all Company pre- and post-marketing safety surveillance activities for its products throughout the life cycle in compliance with International Council for Harmonization (ICH) guidelines, FDA/EMA applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP), and Company procedures.
• Provide pharmacovigilance and drug safety leadership and input for the Company's clinical development and postmarketing programs, including Clinical, Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs while collaborating with Clinical Operations, Medical Affairs, Data Management, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs), and other internal and external entitles to contribute to overall program execution while ensuring safety strategy, quality compliance and operational excellence.
• Contribute to the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents, including protocols, informed consent/assent forms, Case Report Forms (CRFs), Statistical Analysis Plans, Clinical Study Reports/synopses, Integrated Summaries of Safety (ISS), New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory agency responses, Institutional Review Board (IRB)/Ethics Committee (EC) requests, briefing books, manuscripts/journal article, and other documents.
• Direct the creation and maintenance of the Company's Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI), including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels, and other associated product labeling.
• Oversee the preparation of pre- and post-marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and Six-Month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports, ensuring safety profile/topics across various regulatory safety documents for the Company's assigned products.
• Oversee risk-benefit evaluations, the preparation and review of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization, and effectiveness measures in accordance with regulatory requirements.
• Develop and manage pharmacovigilance activities and safety data exchange agreements with company's license partners.
• Responsible for overall vendor performance and vendor service outputs (delivered timely and within budget) including but not limited to:
o Governance of US adverse event (AE)/product complaint (PC) call center;
o Governance of individual case safety report (ICSR) processing by outsourced CRO vendor, including the review and monitoring of compliance through various monitoring reports/key performance indicators (KPIs);
o Review and approval of safety-related section of aggregate reports (DSUR, PSUR, PADER, RMPs);
o Collaboration with vendors to develop process-related documents for the purposes of improvement and standardization of new processes;
o Implement and maintain knowledge of safety database systems, ensuring all Company ICSRs are included within a global safety database.
• Develop and maintain pharmacovigilance quality system.
• Contribute to development and maintain the Pharmacovigilance System Master File (PSMF) to support European filings and regulations as applicable.
• Create and maintain standard operating procedures and working practices to ensure inspection. readiness and compliance with regulations and guidelines.
• Serve as the company's pharmacovigilance subject matter expert when participating in internal/external audits and regulatory inspections.
• Manage pharmacovigilance budget and forecasting activities.
• Support signal detection activities to ensure signal identification, evaluation, and validation, and communication of safety assessments (written and verbal) of safety risks in collaboration with essential team members.
• Support preparation and participate in Safety Management Team (SMT), Benefit Risk Assessment Team (BRAT), and other forum meetings to ensure oversight of all company products.
• Represent the company in product safety meetings with its license partners and CROs
• Provide training to company personnel regarding pharmacovigilance requirements and compliance and manage training compliance.
• Maintain current knowledge of global regulations and regulatory guidelines.
• May perform other drug safety and pharmacovigilance activities appropriate to experience and expertise.
Required Qualifications and Skills
• Bachelor's degree in scientific / technical discipline, RN, or equivalent healthcare experience
• At least 7 years' drug safety experience in the pharmaceutical industry
• Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices
• Solid experience with drug safety databases, especially with Argus
• Solid vendor management/governance experience
• Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
• Excellent leadership qualities and written and verbal communication skills
• Ability to work in a dynamic, fast-paced environment with shifting priorities
• Experience with internal audits and global regulatory inspections
• Strong organizational and project management skills
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
• Travel Requirements:
