Pharmacovigilance Physician Global

Vor 3 Tagen

Basel, Schweiz Hengrui USA Vollzeit

**Reports to (Title): Head of Global Pharmacovigilance**
**Location: Global/USA/Europe**
**Exempt/Non-Exempt: Exempt**
**Direct Reports : None**
**Department: Pharmacovigilance**

The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the US, Europe and Japan. Our ex-China team drives strategy and operational implementation for clinical development, regulatory approval and commercial success.
Our parent company Jiangsu Hengrui Medicine (600276 SHA) is a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. Our pipeline opportunities include antineoplastic, metabolic, cardiac, surgical, contrast agents, anti-virals, and antibiotics. The therapeutic areas are diverse, covering oncology, autoimmune, pain management, neuroscience, metabolics, etc.
We recognize, appreciate, and reward our team's contributions; we emphasize our people's well-being. We want our employees to feel empowered to do their best work, to engage in shaping our growing ex-China organization and to be part of a team where they are respected, engaged, fulfilled, and developing

**Job Summary**:
The Director PharmacovigilancePhysician serves as the safety expert accountable for the global safety strategy and overall safety profile for his/her assigned investigational Hengrui products throughout their lifecycle.
This role will be responsible to bring together the relevant development functions from our US and EU team, as well as the teams in China, to drive proactive and cross-functional global Safety Management Teams with a global focus. This includes leading the development and implementation of the cross functional product Aggregate Safety Analysis Plan and providing medical safety leadership to all major pre
- and postmarketing safety related deliverables, including signal work up, benefit-risk evaluation and risk management activities.
This individual must effectively interface cross-functionally at all levels across our global organization as well as with external regulatory authorities. You will work together with other Drug Safety (DS) staff located in the US and EU, and at Hengrui Headquarters in China. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
Joining our team at this time offers the opportunity to contribute to the build up the medical safety roles - working as part of a Global Product Team to develop and implement the product level global development strategy, and contributing to the technical and competency growth of our expanding global PV function.
**Essential Job Functions**:

- Lead the product level global Safety Management Team
- Work closely with clinical teams, PV Operations and CROs to ensure appropriate business decision making to deliver the safety of our patients and our compliance with regulations
- Lead the cross functional development and implementation of the product level global Safety Profiling Plan/ Aggregate Safety Analysis Plan
- Lead the proactive surveillance and integration of safety data from different sources for Hengrui products
- Develop and implement the medical safety strategy for assigned products e.g. clinical development plans, trial protocols, clinical trial reports,, eCRFs/CRFs, TMFs,, Subject Informed Consent, IBs, DSURs, Integrated Safety Summaries, PBRERs, RMPs, scientific articles, etc.
- Prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds
- Ensure appropriate handling and communication of safety issues and the implementation of risk mitigation activities
- Active involvement in external data monitoring committees (DMCs)
- Collaborate with external experts and partners
- Ensure compliance with regulatory guidelines and internal procedures in order to be prepared for audits and inspections
- Actively contribute to process and system development, including regulatory intelligence, best practice development, SOP development, implementation of new technologies and CAPA management
- **Job Requirements**:
**Experience / Education**
- Medical Degree (MD) required
- Clinical research and/or fellowship training in oncology, onco-hematology, internal, cardiometabolic diseases, autoimmune diseases, pharmacology or other relevant specialty is a plus.
**Knowledge / Skills / Abilities**
- Solid Drug Safety / Pharmacovigilance experience in the Pharmaceutical industry
- Excellent knowledge of drug development process
- Excellent understanding of global PV regulatory environment with good working knowledge of international regulations, initiatives, standards inc GCP and GVP
- Working knowledge of individual adverse event case report processing, triage and medical review.Working knowledge of MedDRA and WHODrug coding dictionaries. Working knowledge of safety databases, electronic data capture syste

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