senior PV specialist（外资药企，8个月temp）

Primary responsibility
The Local Medical Safety (LMS) Case Management Senior Specialist is to
 Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
 The scope of support is primarily focused on countries. The role holder may be expected to support and ensure case management and related activities for other countries within the ASPAC Region (centralized case management) are carried out in a timely manner.
Handle the following tasks, independently and with minimal supervision.
 Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
 Enter relevant/required safety data into the Global Safety Database from spontaneous, clinical trials and other solicited sources.
 Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
 Data entry for complex cases
 Performing follow-up for requesting additional information from multiple sources.
 Assist in the quality review of data captured in the Global Safety Database as applicable
 Verify and ensure translation of safety information, if applicable.
 Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
 Enable mechanisms to support Country Safety Head oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.
 Liaise with applicable stakeholders to support case processing requirements for Medical device vigilance and pharmacovigilance.
COMPLIANCE MONITORING
Handle the following tasks, independently and with minimal supervision.
 Ensure accurate and timely documentation of deviations to process/timelines, including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs) as applicable.
 Support Country Safety Head in review of new/revised PV regulations, evaluation of the impact on local processes and notification of appropriate global and regional
AUDIT / INSPECTION PREPARATION AND SUPPORT
 Represent LMS Case management or support Country Safety Head, in matters pertaining to audit or inspection preparation or conduct.
Handle the following tasks, independently and with minimal supervision.
 Ensure and support other case management related activities such as:
o Vendor training, on-going vendor support on a case level (daily or as required), case review, and vendor oversight (daily or as required)
o Local literature screening for ICSRs and potential safety signals (in consultation with local medical safety colleagues as needed).
o Periodic reconciliation activities
o Support LMS Case Management Team Lead / Country Safety Head in responding to ad hoc requests (e.g. regulatory authority requests) as required.
o Lead or support case management related innovation roll-out, in collaboration with the LMS Case Management Team leads
o Lead or support the coordination and process standardization efforts to cross-country collaboration with regards to case management activities, as applicable
o Write or review ICSR related procedural documents and local memo implementation as applicable.
o Act as a mentor to junior staff and quality checking their work
o Lead or support critical project work
Academic qualification
 A degree in life, health or pharmaceutical sciences is preferred e.g. Pharmacist, Medical doctor, Biologist.
Essential knowledge & skills
 Sound knowledge of general medicine, or pharmacy, or clinical practice; proficiency in Medical terminology (local languages).
 Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
 Computer literate with expert knowledge of the Global Safety Database
 Ability to prioritize and work to strict timelines daily
 Excellent verbal and written communication skills
 Fluency in local (if applicable) and English language required
 Ability to negotiate and communicate with internal and external customers
 Knowledge and understanding of key legislation applicable to pharmacovigilance
Experience
 Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable