Pharmacovigilance and Safety Physician (Sr. Director/Director)

Company: Ascentage Pharma
Location: Rockville
Posted on: May 24, 2025

Job Description:

Pharmacovigilance and Safety Physician (Sr. Director/Director)April 10, 2025About Ascentage PharmaAscentage Pharma: (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers and other diseases. Ascentage Pharma is proud of its collaborative, supportive culture, unified by the desire to develop therapeutics that will have a positive impact on patients' lives. The company is defined by a shared understanding it succeeds in advancing its mission only as each individual experiences success in their role.Leveraging our robust internal research and development capabilities, we have built a portfolio of global intellectual property rights. We have also established global collaboration relationships with leading biotechnology and pharmaceutical companies. We are a leader in global innovation with a portfolio of more than U.S. and international patents and more than U.S. and international pending applications.We have assembled a talented, global team with experience in the research and development of innovative drugs, as well as commercial manufacturing, sales, and marketing. Our success is shaped by this global team of close to 600 employees across the United States, Europe, Australia, and China.Bilingual Candidates: Mandarin & English Strongly Encouraged To ApplyResponsibilities

• Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Ascentage standards.
• Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
• Provide oversight for the safety aspects for clinical studies, including participation at DMC meetings, and development and maintenance of the company core safety information.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, informed consent forms, final study reports, IB/RSI and other documents as needed.
• Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
• Lead the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
• Assess safety signals and trends and proactively manage any potential safety issues.
• Determine need for pharmacoepidemiology input and liaise with external pharmacoepidemiologist.
• Lead development of Risk Management Plans, implementation and evaluation of their effectiveness.
• Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
• Author analysis of similar events (AOSE) and individual case comments for ICSRs.
• Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (DSUR, PADER, PBRER/PSUR) and ad hoc safety assessments.
• Maintain knowledge of global regulatory authority regulations including FDA and EMA.
• Formulate response strategies for safety-related health authority and ethics committee requests.
• Represent PV in communications with health authorities such as the FDA.
• Participate in departmental development activities including SOP and Work Instructions development.
• Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
• Contribute to the training, leadership, and continuing education for department staff.
• Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.Education, Experience and Requirements:
  • MD degree or equivalent
  • 15 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development.
  • A minimum of 12 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including a minimum of 8 years of safety leadership experience. A mix of large and small company experience highly preferred.
  • Hematology - Oncology related disease experience also a plus.
  • Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonization (ICH) guidelines.
  • Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
  • Extensive knowledge of all types of aggregate safety reports.
  • In-depth understanding of the drug development process.
  • Extensive experience in partnering with vendors to achieve results.
  • Fluent in English with exceptional written and verbal communication skills.
  • Ability to build and sustain trusted relationships both internally and externally.
  • Deep understanding of regulations, knowledge and practices required for pharmacovigilance, e.g. ICH guidelines, international pharmacovigilance regulation, Chinese regulations, industry practice, etc.
  • Strong interpersonal skills and communication skills, with the ability to work with others at all levels and from a wide range of backgrounds in the company (incl. internal and external).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.
    • 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.What We Offer and Why Join Ascentage?At Ascentage you'll have the chance to be part of a team bringing first-in-class treatments to patients who need them most. We offer a supportive culture that puts people first. We provide an extremely competitive compensation and annual bonus, and our benefits package includes: medical, dental, vision, life insurance, STD/LTD, company matched 401(k), employer paid life insurance, employee assistance program, wellness programs, generous vacation/sick plans, flexible work schedules, team building celebrations, employee discounts and much more.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.To apply please send your CV to hr@ascentage.com
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Keywords: Ascentage Pharma, Dundalk , Pharmacovigilance and Safety Physician (Sr. Director/Director), Executive , Rockville, Maryland