GlaxoSmithKline Recruitment 2021 for Safety/ Pharmacovigilance At Brentford, United Kingdom; Wavre, Belgium; Bangalore, India.GlaxoSmithKline Notification full detailes below.Interested Candidates Apply Now.
- Important Vacancy details:
- Company Name:GlaxoSmithKline
- Post Name: Safety/ Pharmacovigilance
- Location: Brentford, United Kingdom; Wavre, Belgium; Bangalore, India
- Contact Number:NA
- Selection Process: The selection will be on the basis of Interview.
Job Description: We have Hiring For Safety/ Pharmacovigilance in GlaxoSmithKline !
Closing Date for Applications: Monday 20th September 2021
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create an engine for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants, patients, and consumers administered or using GSK products, by supporting the successful collection, processing and reporting of safety data of GSK products globally.
This role ensures that case management activities align with GSK standards for processing human safety information (HSI) and that regulatory requirements, including timelines are achieved. This is done by driving the implementation of robust processes and training for successful performance of case management activities, including PV vendor oversight mechanisms.
The job holder provides relevant CMG Excellence-related oversight to the Case Management Group (CMG) Directors and drives the understanding of case management requirements across all business units.
Key Responsibilities include, but are not limited to:
- Contributing to all aspects of processes and written standards that describe case handling activities from case receipt to expedited reporting and collaborates with stakeholders (e.g. the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and Clinical Operations) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.
- Working across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements
- Where process or training issues are identified, facilitates investigation into root cause, creation of corrective/preventative actions (CAPAs), and supports with remediation of process/training needs
- Reviewing and maintaining oversight of any CMG training materials developed
- Preparing internal and external presentations as required, working closely with content owners and experts within the team
- Implementing changes to CMG training curriculums in line with current CMG structure and maintains oversight of all CMG training aspects
- Managing CMG Excellence mailboxes for responsible workstream and responds to allocated queries in a timely and professional manner
- Identifying changes to regulations that may impact CMG activities, assesses impact, coordinates implementation of changes and tracks change
- Tracking and overseeing regulatory enquiries sent to CMG, ensuring appropriate, thorough and timely responses
- Coordinating appropriate archiving, in line with GSK Global Archiving processes, ensuring the successful retrieval of documentation and supporting inspection-readiness
- Where problems or issues are identified, escalates to CMG Director, as appropriate
- Generating new ideas and proposals for global implementation; contributes to advancement of CMG methodology and optimization of processes.
- Demonstrating GSK values during interactions
CMG Manager, CMG Excellence Accountabilities
- Manages a team of up to 10 scientific staff responsible for CMG Excellence activities
- Manages team to ensure appropriate prioritisation and time management, in line with business needs
- Builds external relationships with key stakeholders and senior leaders
- Ensures relevant CMG Excellence-related oversight to the Case Management Group (CMG) Directors
- Resolves issues and concerns within the CMG Excellence team and escalates to CMG Excellence Director, where resolution is not possible or there is impact across CMG
- Ensures that all CMG Excellence activities are appropriately resourced and escalates any resourcing issues
- Provides workload forecasts to other CMG Managers and the CMG Directors and works with CMG Excellence Director to strategically plan, in line with business goals
- Develops the team, identifying training requirements and establish a training plan for individuals, as required
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
Every day, we help improve the health of millions of people around the world by discovering, developing and manufacturing innovative medicines, vaccines and consumer healthcare products. We are building a stronger purpose and performance culture underpinned by our values and expectations – so that together we can deliver extraordinary impact for patients and consumers and make GSK a brilliant place to work.