(Sr.) Specialist, PV

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary

This position represents and is responsible for the local Pharmacovigilance activities of products (drugs) manufactured / imported by Vantive China. Support PV Manager with routine activities in compliance with the national regulations for drugs and relevant Vantive PV procedures.

Essential Duties and Responsibilities

PV Operation   

AE/SAE Processing

•To collect, process and follow up all local adverse events (AEs)/ serious adverse events (SAEs) from different sources (Healthcare professionals, sales and marketing personnel, patients, clinical trials, literature, Investigator Initiated Research etc.)

•To report the AE/SAE to the Health Authority (HA) according to the Chinese regulation within the required timeframe

•To transmit all reports in English to the GPS organization within the required timeframe;

•To archive all source documentation and keep them available upon request by the HA

Hotline handling:

•Monitor PV hotlines and hotline case intake

To support respective MAH PV activities related, such as

•Regular & ad-hoc management review meeting with stakeholders, PV quality matrix presentation

•Safety data provided as request

•Safety analysis report preparation

PV Training:

•Provide PV training to new employee, annual refresh training to all Vantive staff, customer facing staff, third party, etc.

Studies Activities

•Working with clinical operation team to support PV related activities, e.g., setup of AE collection requirements, AE reporting process, reconciliation plan, and performing reconciliation if appropriate

Aggregate Safety Report

•Prepare the Periodic Safety Update Report (PSUR) schedule every year and communicate with GPS medical safety writing team

•Communicate with GPS safety writing team to draft PSUR following China guidelines

•To collect and maintain product registration information and commercial data to be used for PSUR

•Submit PSUR to HA

•Monitor and response to HA’s feedback on the submitted PSUR

•Support the data collection and prepare PV annnual report or MAH annual report as appropriate

Safety Data Exchange Agreement (SDEA)

•Create/update SDEA for new/existing distributors

•Deliver PV training to distributors

•Conduct routine reconciliation of AE received

•Any other SDEA related activities

Patient Support Program (PSP), Market Research Program (MRP), Digital Media

•Collaborate with regional coordinator for new program review, contract review and approval

•Ensure the implementation of safety requirements in the programs by training to vendors, AE reconciliation, and any other actions included

Interaction with internal key stakeholders

ØInternal interaction with manufacturing plant acting as a PV representative for each of the manufacturing plant

ØInternal interaction with QA/RA/MA for investigation of product safety related issues

ØExternal interaction with HA to ensure successful implementation of China PV regulation

ØCoordinate Drug Safety Committee Meeting

PV system process

ØUnderstand China PV regulation and Vantive China business

ØWork with PV manager to improve PV process / system

Ø Create and update Pharmacovigilance Safety Master File (PSMF)

ØSupport business projects via ensuring proper PV process are followed

ØCoordinate and participate PV audits and inspections

AE reports- Case investigation

ØDraft death case investigation report

ØDraft cluster ADR investigation report

ØDraft case analysis report as appropriate

ØPerform safety surveillance activities for potential safety signals (e.g. similar AEs reported in a cluster or multiple cases for one batch) and escalate as per procedures

ØCommunicate effectively any safety signals observed to the appropriate management team

Support the label update and license renewal

ØReview safety section of the label

ØDraft safety summary for license renewal

Qualifications

ØGood communication skills, ability to liaise with different function: QA, RA, MA, marketing and sales team

ØFluent in both in oral & written English

ØIn addition, must have:

-Proactive and Can do attitude

-Attention to detail

-Time Management

-Problem solving capability

Education and/or Experience

ØClinical Medicine or Pharmacy background, or relevant, bachelor or above

ØKnowledge ofthe relevant PV regulations in China. Previous experience in PV: 2 years at minimum

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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