PV Specialist

Job Title: PV Specialist
Basic purpose of the job:
To ensure high quality of Individual Case Safety Report (ICSR) processing and reporting and in
compliance with external regulations and Company internal procedures.
Closely cooperate with internal interfaces and proactive support of people contacting Patient
Safety & Pharmacovigilance (PSPV) department China with regards to Pharmacovigilance
related matters.
Accountabilities:
1. Execution of all ICSR processing (e.g. ICSR collection, ICSR processing, follow-up) and
reporting is compliant with respective Company procedures: - Case classification, intake, and local review of Patient Safety relevant information in Global
Safety Platform. - Coordinates the medical review of incoming case information, where required. - Ensures high quality translation of the case receiving in local language or in case with
complex information (where feasible within the required timelines). - Ensures personal information is redacted from source data in line with data protection
requirements. - Queries concerning case information (=Follow up) are sent out within the valid Company
timelines and properly document in Global Safety Platform. - Queries are easy to understand for external customers and targeted to the missing
information (e.g. by prepopulating forms/questionnaires with available information). -ICSR Submission to local Health Authorities and facilitating submission to the Ethic
Committees/Institutional Review Board (IRB) by Clinical Operation Department is performed
in line with Company processes and regulatory requirements. - Review ICSR related package report (FQTR, LORE, LCPA, DILO, PSUR Interval Line Listing)
within the required timeframe. -Monitors Health Authorities' comments in HA system. -Provide feedback to line manager any discovered findings on enhancement of ICSR
processing process.
2. Contributes to the quality of the local PV system by taking over and executing the following
tasks in line with Company processes and timelines, for examples but not limit to: - Support of local inspections/audits and participation in PV audits and PV inspections as
requested. - Screens local scientific literature for identification of PV relevant information. - Assist line manager or function by the set-up/optimizing of local ICSR related processes
including the takeover of subtasks. - Archiving:
• All relevant documents are independently archived in a timely manner in accordance to
Company processes and regulatory requirements.
• External Archive: Archive retrieval checks are performed independently and timely and are
documented.
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3. Collaboration and contribution: - reporting of non-compliances as soon as become aware of it - Support the implementation activities to enhance PV compliance culture and PV awareness
at local level of the organization in line with global recommendations
4. Additional accountabilities will be assigned per this position, considering the working
experience and task complexity.
Working Experience:
At least 2 years of PV operation working experience.
Minimum Education/degree requirements:
Pharmacist, nurse, life sciences or other related
Degree / Education: Bachelor’s degree or above, Master preferred
Major / Focus: Pharmacy, Nursing, Biology or other related
Required Capabilities: - ability to prioritize workload and perform under stress in situations in which working
efficiency and sustained attention are critical aspects of the job - good technical understanding and experience in working with databases - ability to converse with other medical professionals to collect, interpret and reconcile
complicated medical data - good communication / interpersonal and organisational skills - problem solving skills - ability to work efficiently in a team
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