Director/Sr. Director Pharmacovigilance, Operations and Compliance

Company: Ascentage Pharma
Location: Rockville
Posted on: May 3, 2025

Job Description:

Director/Sr. Director Pharmacovigilance, Operations and ComplianceApril 10, 2025The Director/Sr. Director Pharmacovigilance, Operations and Compliance will play an integral role within our Pharmacovigilance division. Reporting to the Vice President, the successful candidate will be responsible for:RESPONSIBILITIES:

• Build, manage and mentor PV Operations and Compliance team.
• Maintain Ascentage's Global Safety Database (GSBD) and generate reports/LLs from GSBD for Safety Signal Assessment Reports and Aggregate Safety Reports (ASR) such as Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Reports (PADER), IND Annual Safety Reports, and responses to health authorities' requests for safety information.
• Responsible for all PV operation and compliance aspects of all Ascentage's products throughout the product lifecycle from First-In-Human to post-marketing.
• Build and implement pharmacovigilance systems compliant with global PV regulations.
• Responsible for ICSR case processing and reporting, and aggregate safety reporting.
• Manage the process for identifying, evaluating, and selecting outsourcing safety vendors.
• Provide vendor oversight for all outsourced PV activities, including establishing and monitoring key quality and compliance metrics.
• Responsible for PV Agreement/Safety Data Exchange Agreement with license partners and distributors.
• Responsible for PV operation related inspection, audit, CAPA, etc.
• Build PV infrastructure, PV system and PV process for inspection readiness and launch readiness in compliance with the global safety regulations and guidelines.
• Responsible for development and training of all PV operations and compliance related SOPs and work instructions.
• Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), and other relevant documents.
• Assist the Head of PV & Safety to plan department budget, develop short-term and long-term goals for the department in accordance with overall Company and Development strategies, facilitate department meetings and prepare agendas/meeting minutes.
• Occasional international/domestic travel required.QUALIFICATIONS:
  • Health Care Professional degree is required (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D).
  • 15+ years' experience in PV Operations at global pharmaceutical or biotechnology companies, including 8+ years' experience as a people manager in PV operations in the clinical trial and post-marketing environments, is required. Pharmaceutical Industry experience strongly preferred.
  • 5+ years' experience as a Department Head of PVO is preferred.
  • Extensive experience in ICSR management/processing, aggregate safety reports, Argus Safety Database and MedDRA coding.
  • Strong knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes.
  • Broad knowledge of FDA and EMA regulations, GCP/GVP/ICH guidelines, and other local/global safety regulations.
  • Excellent verbal communication and presentation skills with ability to write clearly and concisely.
  • Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective international collaboration.
  • Time management skills with ability to prioritize meeting required deadlines.
  • Ability to work with ambiguity.
  • Bilingual Candidates (English and Mandarin) are strongly encouraged to apply.CULTUREAt Ascentage Pharma, we strive to create a culture based on personal and professional growth and opportunity, focusing on these principles:
    • Establish a collaborative, energized and fun work environment where people are empowered and supported in achieving their career goals. Working at Ascentage Pharma allows you to balance your priorities.
    • Create a diverse and multi-disciplinary workforce at all levels.
    • Cultivate dedicated, talented, and entrepreneurial people who are passionate about achieving excellence in all they do every day, with a shared commitment to science and to the patients we serve.COMPENSATION AND BENEFITSAscentage Pharma offers an extremely competitive compensation package, including an annual bonus.Ascentage Pharma also offers:
      • Exceptional Medical, Dental, and Vision plans for employees and families.
      • Employee paid life, STD & LTD as well as a comprehensive insurance package with spouse life Insurance, Critical Illness, and Accident Insurance.
      • 401K with an immediate and generous company match.
      • Liberal paid time off.
      • Flexible schedules for staff and employee assistance program.Ascentage Pharma is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is Ascentage Pharma's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, marital status, status as a protected veteran, or any other legally protected group status.
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Keywords: Ascentage Pharma, Olney , Director/Sr. Director Pharmacovigilance, Operations and Compliance, Executive , Rockville, Maryland