Patient Safety Manager

Posted 04 Mar 2019

Beijing - all, Beijing - China

Req Id 188366

Details

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

The role is accountable to ensure full compliance with all relevant global and local regulatory requirements, internal company standards and best practices in the pharmaceutical industry for pharmacovigilance (PV). The role is accountable to ensure the secure functioning of the local PV system in accordance with the global Biopharma PV system. This includes continuous exchange with the GPS Region and local key stakeholder functions (i.e., Medical Affairs, Regulatory Affairs, Quality Assurance, Global Clinical Operations, Regional Clinical Operations, and Commercial Organization etc.). As applicable the role is directly accountable for the management of some of patient safety staff in the affiliate within the designated territory.

The accountabilities include:

1. Management of the local Patient Safety Department:

•Leading and executing operational tasks in the affiliate/s relating to PV

•Managing local PV vendors with assigned PV tasks

•Implementation of processes and tools in a timely manner to ensure effective and efficient use of all resources

•Management of work load and budget to meet defined objectives and targets

•Creating a working environment that attracts and develops and retains good performers

•Actively using mentoring and coaching approaches based on GPS and standards to identify and develop talent in the local department.

2. Local PV System

•Establishing and maintaining the local PV System in accordance with global / local legislation and company standards

•Accurate and complete documentation and maintenance of the local PV System in the local PV File (LPVF) based on the current LPVF template

•Ensuring that all relevant process documents are current, complete, version controlled and retrievable

•Ensuring that local patient safety staff is trained on relevant procedures and documentation of the PV System

•Ensuring continuous inspection-readiness for any PV-related inspections by health authorities and for all PV-related internal audits at the affiliate

•Preparation, coordination and participation of local PV related audits and health authority inspections

•Support of global PV related audits or health authority inspections as requested

•Specific PV tasks may be delegated to a third party by GPS in order to strengthen and harmonize PV system activities. The scope and the supervision of such activities are described in the respective contractual arrangements.

3. Product safety surveillance

•Handling of all local safety information, including collection, registration, translation from local language into English, and transmission to GPS as applicable in a timely manner

•Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner

•Performing screening of relevant local medical/scientific literature in accordance with GPS procedures and local requirements

•Performing screening of relevant local health authority web sites according to global standards as defined by relevant quality documents

•Implementation and oversight of Risk Management Plans (RMPs) and additional Risk Minimization Measures as required in close collaboration with central GPS teams

•Conducting signal management activities as described in GPS procedures and according to local requirements

Reporting of safety information to local Health Authorities:

•Reporting of relevant ICSRs to local Health Authorities as required

•Reporting of relevant ICSRs to local Ethic Committees as required

4.Involvement in local studies and Patient Data Collection Systems (PDCS)

•Reviewing safety related contents of local study/PDCS documents (protocols, amendments, informed consent forms, contracts of 3rd parties involved in the studies) and providing safety input as needed

•Ensuring appropriate safety procedures (including appropriate safety reporting to health authorities, regular reconciliation of safety data between applicable databases, safety training of all involved internal or external personnel, following up on specific issues until resolution)

•Informing GPS on all new local studies as required and PDCSs as defined in the relevant quality documents

•Performing required activities (such as review and input to safety section of study/project documents, certification of programs, AE reconciliation, providing updates) for local studies /PDCS as required and provision to GPS Regions

•Maintenance of oversight of all ongoing study / PDCS activities

5. Safety information requests from Health Authorities

•Immediately informing GPS at HQ and other relevant functions at local level of any safety-related requests from local Health Authorities

•Collaborating closely with GPS/Regulatory Affairs/Medical Affairs/Clinical Development/Quality Assurance on the preparation of appropriate response documents to Health Authorities

•Ensuring appropriate contact person for internal and external safety-related matters for the local Health Authority

6. Local safety regulations and regulatory status

•Continuous monitoring of local PV legislation in the country(ies) / territories of responsibility

•Immediately informing GPS at HQ of any changes of the local PV legislation

•Informing local management, local stakeholders and GPS about any relevant changes in local legislation

•Having an oversight of the benefit-risk profile of all products on the market and under development in the country(ies) / territories including active ingredients from competitors

•Informing GPS immediately of any new or withdrawn marketing authorizations for local products (including in- or out- licensed products)

•Supporting GPS Compliance and Standards to ensure that all required Safety Data Exchange Agreements (SDEAs) are in place in a timely manner and are up-to-date (including appropriate PV language in relevant contracts and commercial agreements)

7. Local training activities

•Providing necessary support as applicable to GPS for timely completion of corporate Basic PV Training by all employees and relevant 3rd parties. Providing training on relevant safety-related matters for local functions such as Medical Affairs, Regulatory Affairs, Clinical departments, Commercial departments and third parties as necessary

•Tracking, documenting and archiving of PV training activities in line with local legislation and company standards and policies

8. Management of PV compliance at local level

◦Ensuring local compliance in accordance with local legislation and company standards/procedures

◦Ensuring compliance with and appropriate execution of Service Level Agreements with partners such as Allergopharma etc.

◦Providing regular compliance information to GPS in a timely manner

◦Ensuring appropriate root cause analysis for any identified deficiency in the local PV system (including audits/inspections)

◦Pro-actively identifying compliance issues and compliance gaps, following up and closure of observations in close cooperation with GPS and R&D QA

◦Performing reconciliation of safety information (e.g. ICSRs from spontaneous, solicited, study, complaint and PDCS sources) with the relevant functions

◦Local documentation and record retention in accordance with local legislation and company standards

•Archiving of local PV source documents in accordance with company policies and local requirements

•Archiving of documents submitted to local health authorities (if necessary to ECs)

•Archiving of Trial Master File related documentation

Who you are:

•Medical doctor, pharmacist, bio scientist, or similar qualification to be decided on individual basis

•Excellent in written and spoken English and local language

•Experience the pharmaceutical industry (approx. 10 years), in an affiliate setting preferably as local responsible for patient safety

•Experience in people management and process management

•Knowledge of regional and local PV requirements

•Knowledge of project management

•Good understanding of drug development and life-cycle management 

HR95598

Functional area: Regulatory & Medical Affairs


What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at https://jobs.vibrantm.com
 

Apply Now

Let’s stay connected

Do you want to receive company news and information about career opportunities tailored to your preferences? Sign up here. You want to check the status of your application or change your candidate profile? Enter our job portal.

Redirect

You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

Let's go

Share Disclaimer

By sharing this content, you are consenting to share your data to this social media provider. More information are available in our Privacy Statement