Website InnoCare Pharma Inc. (US)
InnoCare Pharma is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing best-in-class and/or first-in-class drugs for the treatment of cancer and autoimmune diseases.
InnoCare has strong in-house innovation capabilities, holding multiple foreign and domestic patents with a rich product pipeline target liquid tumors, solid tumors, and autoimmune diseases. Our team has discovered and developed our current pipeline of over 10 novel drug candidates, including our core product candidate Orelabrutinib, whose NDA was accepted and granted priority review by the NMPA earlier this year.
InnoCare was co-founded by Professor Shi Yigong, a world-renowned structural biologist, and Dr. Cui Jisong, an outstanding leader in the biopharmaceutical industry. We have nearly 300 employees, including over 100 researchers. Our core R&D staff brings rich experience from the world’s top pharmaceutical companies, such as Pfizer, Bristol-Myers Squibb, Merck, Johnson & Johnson, Bayer, etc. We are a truly global biopharmaceutical company with sites in Beijing, Nanjing, Shanghai, and Guangzhou, in addition to branches in New Jersey and Boston for US development and clinical management.
On March 23, 2020, InnoCare was officially listed on the Hong Kong Stock Exchange (code: 9969). Our vision is to become a world-class leader in innovative medicine and lead China’s medicinal research into a new era.
Director to Executive Director, Pharmacovigilance
JOB TYPE: Full-time
Location: Princeton, NJ, US
Reports to: Chief Medical Officer
Provides strategic leadership and oversight for the pharmacovigilance and drug safety function of the company’s global clinical studies. Accountable for pharmacovigilance activities according to Global Legislation. Ensures proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of all products. Ensures successful implementation, execution, and maintenance of safety-related strategies, processes, and systems that conform to the company’s business strategy, industry standards, and compliance with regulations.
- Effectively manages the drug safety function to ensure that safety reports received from clinical trials (and post-marketing) are processed and reported according to ICH-GCP guidelines, regulatory requirements, and company SOPs and procedures.
- Provides medical expertise in the review and analysis of clinical study safety information.
- Participates in the review of individual SAE reports, prepares medical commentary and analysis, and in the preparation of safety evaluations in aggregate periodic reports.
- Ensures accurate medical coding (MedDRA and WHO-DD) of safety data
- Represents the Pharmacovigilance & Drug Safety department in safety-related discussions with clinical investigators, IRBs/ECs, Data Monitoring Committees, and regulatory authorities.
- Protects study subject safety by contributing to the ongoing risk/benefit analysis of investigational drugs in clinical development.
- Prepares and maintains departmental policies and SOPs that address the processing, analysis, and reporting of safety information to ensure proactive surveillance of products.
- Participates in health authority interactions (both written and verbal) and inspections regarding safety and risk management
- Ensure local and global risk management plan preparation and execution throughout a medicinal product’s lifecycle.
- Perform drug safety signal detection activities for the company’s portfolio of investigational and marketed products; develop medically reasonable evaluations of safety signals; and make specific, actionable, and defensible recommendations for confirmation or refutation of safety signals.
- Manage and monitor benefit-risk evaluations to ensure favorable benefit-risk balance.
- Medically review ICSRs and provide follow-up guidance to the Case Operations team to ensure consistent high-quality reports.
- Participate significantly in the development and production of integrated summaries of safety, clinical overviews, and other registration documents for new and supplemental NDAs and/or ex-US new drug submissions/variations for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs.
- Drive the safety strategy for Reference Safety Information for company products, including Investigator Brochures and new or updated labeling (USPI, SmPC, or CDS) for marketed products in the context of multidisciplinary groups within the company or joint committees between external partners.
- Participate in internal safety process improvements and updates, including new means of effective presentation of early-phase clinical study status reports with regard to safety findings.
- Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance and contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specifically identified deficiencies of policy, procedure, or practice in GRMSS.
- Review medical and safety content included in standard response letters prepared by Medical Affairs, as necessary, and work with Medical Affairs to create and periodically revise standard communications that include specific adverse event information.
- Champion risk management safety strategy to internal (eg, Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal) and external (eg, regulators and commercial collaborators) stakeholders.
- Other responsibilities, as necessary.
Qualifications and requirements:
- M.D. or Degree in Pharmacy
- 10 years relevant pharmaceutical industry experience, preferably including both clinical development and post-marketing pharmacovigilance experience. Clinical training and practice experience are preferred. An appropriate title will be offered depending on candidate’s credential and working experience
- Advanced knowledge of Pharmacovigilance relevant/safety regulations, Good Clinical Practices, principles of drug development, product development process and safety assessment of investigational drugs
- Prior experience with NDA/IND
- Experience in developing and implementing risk management strategies and plans
- Demonstrated experience in strategic and multi-project planning
- Excellent verbal and written communication skills, including formal presentation skills
- Fluent English and Mandarin
- Flexibility with work hours; night TC with corporate office in China