Pharmacovigilance and Safety Physician (Sr. Director/Director) Job at Ascentage Pharma, Rockville, MD

N3hFTjNwQUUydzRNTnVDamFqNUR4R2grdVE9PQ==
  • Ascentage Pharma
  • Rockville, MD

Job Description

About Ascentage Pharma

Ascentage 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. Ascentage Pharma is a dynamic and fast-paced organization that has been responsive to the needs of individual employees throughout its history. 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, such as AstraZeneca, Innovent, Merck, and Pfizer, and research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute and the University of Michigan. 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 United States, Europe, Australia, and China.

Bilingual Candidates: Mandarin & English Strongly Encouraged To Apply

Responsibilities

  • 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).

Culture

At 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.

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.

This is the reason why you should join Ascentage, 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.

No agencies please.

Job Tags

Flexible hours,

Similar Jobs

Real Estate Homeselling Team

Real Estate Sales Listing Agent Job at Real Estate Homeselling Team

 ...your career, and put your people skills to good use. If youre ready to take the next step in your sales career, apply now!Responsibilities: Stage and market homes to attract potential buyers quickly Call clients weekly to provide feedback on their property listing... 

The Ritz-Carlton Yacht Collection

Safety Officer (Shipboard) Job at The Ritz-Carlton Yacht Collection

 ...Nautical Employment Type: Fixed Term Contract Reporting To: Chief Officer Description The Safety Officer functions as the yachts Statutory Safety Officer and, together with the Chief Officer, oversees, guides and supports nautical operations and maintenance... 

TOP Group - Japanese Recruiting Agency

Chinese Bilingual Sales Specialist Job at TOP Group - Japanese Recruiting Agency

 ...A Japanese Food Supplier, is seeking a Chinese Bilingual Food Sales Associate to join their team. Title: Mandarin or Cantonese Bilingual Sales Industry: Food Distribution Type: Full Time Direct Hire Location: Houston TX Salary:50-55K(base) QUALIFICATIONS... 

Liberty Personnel Services, Inc.

Professional Land Surveyor Job at Liberty Personnel Services, Inc.

 ...Job Details: Land Surveyor - PLS My client a respected civil consulting engineering firm is seeking a Land Surveyor for their Chicago IL area office. Project management skills preferred. PLS license preferred but will consider Surveyor In Training. Successfully... 

Bask and Lather Co

Social Media Coordinator Job at Bask and Lather Co

 ...pricing. The Opportunity ~ We are seeking a creative Social Media Coordinator to join our team and play a vital role in...  ...optimal results. Qualifications ~ Fully on-site position. Remote work not available. Passionate and excited to be a part of the...