Pharmacovigilance (PV) Manager

Duties and Responsibilities :

·      AE processing and regulatory reporting:

-      Ensure the proper and timely processing of AE cases into the BI Global PV Database according to Corporate PV SOP, regional and local PV WI.

-      Safety reporting to SFDA per local regulatory reporting requirements.

-      Maintain a proper and complete PV archiving.

·      Assist PV Head in developing and maintaining appropriate LWIs, in line with regional and Global Pharmacovigilance standards.

·      PV training:

-      Plan, arrange and provide effective PV training to local non PV staff e.g. sales force, medical team, in their responsibilities for reporting of safety information.

-      Develops attractive local training materials to facilitate the training.

-      To train and mentor new PV staff according to defined PV training curriculum.

·      Pharmacovigilance in studies:

-      Provide necessary PV support and guidance for programs in the OPU(clinical trial, Post Marketing Surveillance (PMS) Studies, Non-Trial Activities (NTA), CUP (Compassionate Use Programme), IIS (Investigator Initiated Study), etc.) to ensure that PV process is adequately implemented.

·      Be responsible for negotiation and implementation of local PV agreement and executions of global PV agreement per SOP requirement. 

·      Leads the preparation, co-ordination, conduct and response tointernal audits and external PV regulatory inspections, in collaboration with RCPV/GPV and local functional departments.

·      Provide PV updates to relevant internal customers (including marketing and sales) to boost PV awareness in BI China as necessary.
Maintains indepth understanding of safety profiles of BI products marketed or investigated in the BI China and is able to represent local PV function on BI multi functional teams, providing input on PV issues/emergency/crisis with support from PV head/Medical VP/RCPV/GPV.

·      Maintain vigilance of China local AE/SAE, screen and evaluate striking cases for safety signals.

Qualifications:

·      Bachelor degrees above, Bioscience but medical back ground preferred.

·      5 years or more experience in PV field, including at least 2 years in top Pharmas PV function.

·      Full of passion in PV discipline.

·      Sound clinical and scientific knowledge and experience.

·      Excellent communication skills.

·      Good understanding of drug development process.

·      Familiar with GCP, ICH guidelines and SFDA, FDA and EMEA PV regulations.

·      Exhibits professionalism and strong business ethics by maintaining confidentiality where appropriate, exhibiting candor and honesty with co-workers, and respecting Company policiesand privileges.

·    Manages multiple tasks and able to prioritize work and meet deadlines for regulatory submissions, customer enquiries etc.