(高级)药物警戒经理
勃林格殷格翰投资有限公司ShanghaiUpdate time: June 5,2019
Job Description

Talent@Boehringer Ingelheim

About Boehringer Ingelheim

Join Boehringer Ingelheim and be part of a legacy where your growth is just as important as ours. A global, research-driven pharmaceutical company, we are one of the world’s top 20 leading pharmaceutical companies and havecollaborated and innovated medicines in Human Pharma, Animal Health and Biopharmaceutical everywhere in the world for over 130 years. This is your chance to create ‘Value through Innovation’ with our internal and external partners to improve lives around the world, explore new scientific breakthroughs to stay at the forefront of our industry, and become a leader for future generations. We continue to grow fast and are one of the top growing companies in the industry in China. Join us and be part of our continued journey to grow and achieve


BI global Ambition 2025:

? No. 1 in Animal Health

? No. 1 in Biopharmaceutical Contract Manufacturing

? No. 1 in value share for our brands in One Human Pharma


As a leading company, Boehringer Ingelheim thrives on passion, innovation and independence, and offers fulfilling work and growing opportunities to highly dedicated people. Certified as Top Employer in China in the past 5 continuous years, we help our people grow towards their success through high quality career development programmes and opportunities to lead international projects to develop into a leader of tomorrow. At the end of the day, your growth is our growth and vice versa.


About Human Pharmaceutical Business

With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. Our innovative medicines include those for COPD, hypertension, stroke, atrial fibrillation-related stroke prevention, Parkinson’s disease, diabetes and non-small cell lung cancer. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients. This vision is supported by industry-leading levels of investment. This includes more than a hundred R&D pipeline projects, around 50% of early- to mid-stage pipeline anchored in external innovation (2016), and around 20% of net revenue invested in R&D (2016) at a global level. Meanwhile, as one of the Company’s strategic pillars in China, Research Beyond Borders (RBB) explores emerging science, indications and technologies to expand R&D opportunities in China, and even the entire Asia.


Job Responsibilities

Line management of the local PV team to ensure the establishment and maintenance of a local pharmacovigilance (PV) operation system, ensures daily PV operation tasks in the assigned territory , fulfills compliance with external requirements in line with the local PV legislation and applicable internal procedures and processes allowing the company to obtain and maintain marketing authorization of its products.

Leads the management of PV relevant information received locally (e.g. ICSR collection, local processing, follow-up, reconciliation, documentation and archiving) including PV reporting to local Health Authorities/Ethics Committees in line with applicable regulations. Ensures the process and implementation of local scientific literature screening for identification of PV relevant information.

Ensures the preparation and submission of local periodic reports with country-specific format and content if needed in liaison with GPV functions.

Implements activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations.

Maintains appropriate PV knowledge to ensure that BI staff fully complies with PV-relevant regulations in the respective territory.

Proactively cooperates with PV Intelligence, GPV Operations and other Line Functions such as Regulatory Affairs on any upcoming new regulations to assess the local impact and their implementation.

Gives PV input to local / Regional innovative drug development and marketing activities such as Compassionate Use Programs, Non Trial activities, Non-Interventional Studies in liaison with GPV functions

Manages local Pharmacovigilance Agreements (PVAs) in cooperation with Global Partner Management

Regularly updates the TCM PV head and local leadership team about the performance of the local PV system and proactively escalates any issue

Contributes to the PV Quality system in ensuring that the PV Local Working Instruction and the local PV system repository correctly describe the local PV system and reflect global PV-relevant processes as well as specific local requirements ensuring local PV inspection readiness and participation in PV audits and local PV inspections cooperating with GPV compliance in identification of PV and PV-relevant non-compliances (NCs) occurring during routine business and timely CAPA development and implementation as assigned for NCs, observations from PV audits and inspections. ensuring that an up-to-date PV business contingency plan is in place.

Qualifications

  • Education/Degree Requirements: Bachelor degree or above
  • Major: Medical or pharmaceutical or bioscience graduate
  • Language skills & proficiency: Good command of written and verbal English
  • Required capabilities (skills, experience, competencies): Well knowledge of Lifecycle Safety processes; Good understanding of applicable global, regional, local PV requirements and all entry-level activities; Experience of people management; Ability to lead or manage projects; Ability to make decisions with an understanding of the consequences; Ability to solve basic problems and able to work independently, guided by procedures, with appropriate support; Ability to achieve personal objectives while meeting departmental standards of performance; Has demonstrated commitment in pushing self and others for results; Able to analyse and synthesize information; Effective mentoring skills; Good attention to detail & Good time management & Good multiple projects management; Ability to be flexible and receptive to changing process demands; Ability to establish and maintain effective working relationships with coworkers, managers and clients. Demonstrable communication skills; Presentation skill: Able to effectively organize key points and supporting information for a topic; At least 6 years working experience in PV area in the international pharmaceutical industry, including 2~3 years of people management experience.

Behaviours

Accountabilities – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions

Agility – Quickly act with an open mind to face internal and external transformation

Intrapreneurship – Together with customers, come up with innovative ideas to respond to changing markets


Contact Us

If you think you can convince us that you are the right candidate we are looking for, apply now!


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