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开发创突破性新药造福病患


Position: PV (Associate Director/Director)

Location: Shanghai

Your Key Accountabilities

1.  Responsible for the design and implementation of PV strategy at company level and at compound level.

2.  Set safety strategy and responsible for the continued safety assessment, evaluation and risk management throughout various stages of clinical development

3.  Review and analyze patient safety data from clinical trials; identify and investigate safety signals; manage and balance ongoing benefit and risk profile.

4.  Accountable for all PV activities associated with filing and approval of clinical and marketing applications;

5.  Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities;

6.  Manage safety surveillance and data collection, in cooperation with a PV vendor, of current trials or real-world use for safety signaling; identify and investigate safety signals; provide patient-level narratives and adjudication.

7.  Provides oversight and review of vendor activities. Oversight activities include monitoring compliance, effective communication and implementation of corrective and preventive actions, as needed.

8.  Conduct analysis of safety data. Ensure adequacy of recording, summarizing, and handling of adverse events for investigational products including decisions on seriousness, expectedness, and causality.

9.  Contribute to the development and implementation of risk minimization action plans.

10.  Provide leadership on clinical safety content of marketing applications (e.g. NDA/MAA Clinical Safety Summary and Risk Management Plan).

11.  Accountable and responsible for designing and executing strategy supporting medical review of ICSRs from all sources.

12.  Responsible for responses to inquiries from regulatory authorities or HCPs on safety issues.

13.  Work with clinical programs as medical advisor

14.  Provide safety strategic leadership for clinical development programs/program teams; integrate the safety scientific component to build a strategic framework for clinical development plans.

15.  Represent Drug Safety and Risk Management at internal and external meetings including business partners, the medical community as well with global regulatory authorities.

16.  Maintain PV quality and develop/update PV SOPs/training programs as necessary.

17.  Responsible for managing cross-functional activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across clinical trials.

18.  Maintains knowledge of adverse event reporting process and safety system and      contributes to the development; improves and standardizes new processes and methods.

19.  Provides safety training to internal employees and external contractors as needed.




Successful Candidate:

·         Bachelor of medicine. Master’s degree or above is preferred.

·         Minimum 5-8 years relevant experience (drug safety, pharmacovigilance, clinical development, medical affairs) in pharmaceutical industry.

·         Familiar with regulatory requirement in safety aspect during the drug development process and inline products lifecycle.

·         Familiar with MedDRA and safety databases is preferred.

·         PV Vendor management experience is a plus.

·         Strong orientation towards cross-functional teamwork.

·         Details orientated, organized, Open minded, problem-solving skills.

·         Proficiency in English, written and spoken.


Our Offer:

We offer you an open biotech culture, an exciting journey throughout the world of drug clinical research and development. You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific and management skills, and entrepreneur competency. You can also look forward to a flexible working environment, a pleasant and homelike atmosphere as well as competitive incentive package. If you are looking for a big stage for your profession or beyond, if you are willing to walk out of your “comfortable zone” in your career, come and join us!



Contact information:

hr@laeknatp.com