Jun
30
PV Manager
June 30, 2022 | Comments Off on PV Manager
PV Manager
Based in Shanghai
Competitive + Benefits + Bonus
Pharmanovia have an opportunity for an experienced PV professional to join their newly established China Operations. In this role you will be responsible for establishing, maintaining and managing the PV system in China. You will be responsible for performing and supporting and managing end-to-end PV operations in compliance with all applicable local regulations, guidelines, and global business requirements.
Why Pharmanovia?
Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.
Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 250 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.
We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.
Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.
The role:
- Acting as the local expert in the matters pertaining to PV in China
- Acting as the contact for the Health Authorities and PV inspections
- Having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal product(s) for which we hold marketing authorisation(s) and providing input into preparation of regulatory action responding to those concerns
- Ensuring the quality and completeness of PV data submitted to the HA and that these documents are being submitted in accordance with legal requirements
- Having oversight of the PV system in terms of structure and performance and being in a position to ensure, in particular, the following system components and processes, either directly or through supervision
- Establishment and maintenance of a PV system, which ensures that information about all suspected adverse reactions which are reported
- Preparation of Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports/Periodic Benefit Risk Evaluation Reports (PSURs/PBRERs) and reports on company sponsored post authorisation safety studies (PASS) for China
- The conduct of continuous overall PV evaluation during the post-authorisation period
- That any request from the HA for the provision of additional information necessary for the evaluation of the benefits and the risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescription of the medicinal product concerned
- The provision to the HA of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on PASS
- Awareness of any conditions or obligations adopted as part of the marketing authorisation as well as other commitments that relate to the safety of the product(s)
- Awareness of risk minimisation measures and risk management plans, ensuring sufficient authority over the content of the latter
What we are looking for:
- At least 3-5 years in drug safety/PV experience gained in pharmaceutical industry setting
- Experience with interacting with third parties
- Excellent knowledge of Good PV Practices
- Direct experience in compliant quality systems
- Experience with Adverse Events Intake systems
- Experience in writing procedures, training materials and effectively delivering training to a diverse audience
- Experience of Audits and Regulatory Inspections preferred
- Proficiency in English
What we offer:
We offer a competitive salary plus bonus and rewards package.
By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.