Advanced Search

Your Browser is Not Supported

To ensure jobstore run smoothly, please use the latest version of the following supported browsers:

Jobs in Malaysia   »   Jobs in Subang Jaya, Selangor   »   Customer Service jobs   »   DCG AP Support Operations Program Manager

DCG AP Support Operations Program Manager

Subang Jaya, Selangor
Apply To This Position
Job Purpose

Patient Support Program Compliance Partner is involved in operational governance and oversight function to ensure Market Research and Patient Support Programs (MAPs) are initiated and executed according to applicable quality standards by the respective MAP owners, as well as to ensure all Patient Support Programs (PSPs) are initiated and executed according to applicable company standards.

Devise strategic oversight plan within the Affiliate/Region/Global Function to identify MAPs through budgeting, market and brand planning information.

Act as point of contact in the affiliate for all communications in relation to MAP including participation in regular MAP lead meetings and regional Business planning meetings

Responsible to ensure oversight and pharmacovigilance compliance through implementation of the Global MAP process and applicable local process and legislation for Patient Support Programme initiated in the MY Affiliate by interacting with Medical, Commercial, Access, drug safety, and the Global MAP Team. Acts as the Cross Functional Owner for the MAP Process.

Required to collaborate with both internal and external cross-functional team members, as well as with external stakeholders.

All Roche employees are expected to practice high standards of compliance with both external and internal policies and regulations as well as participate and be involved in SHE initiatives within the Company.

Responsibilities and Accountabilities:

Key Activities/Responsibilities related to MAPs

Identify groups with a high likelihood of initiating MAPs and ensure there is a mechanism to identify new personnel who require training and collaborate with local quality responsible (LQR) to ensure timely assignment.

Follow up with MAP owners to keep their understanding of the MAP process high and hold annual refresher sessions in these groups to maintain their awareness and understanding of MAPs.

Liaise with local safety unit to organize and run awareness campaigns to increase the awareness and understanding of MAPs in the organization.

Support the organization in identification and classification of all activities that could potentially qualify as MRPs and/or PSPs.

Provide support and direction to MAP owners for MAP initiation and execution.

In collaboration with sourcing/procurement and Local Quality Responsible, ensure service provider selection and respective quality assessment follows the relevant process.

Lead qualification of MAP service providers according to global processes and ensure that the qualification status is tracked and is available to the relevant stakeholders.

Collaborate with Local Drug Safety Unit, Sourcing/ Procurement and Legal to oversee correct PV language in service provider contracts

Oversee setup and creation of the MAP including accurate tracking in the MAP GTT system, and ensure continuous data integrity.

Collaborate with Medical, Commercial, Access, local safety responsible and local quality responsible to ensure that service provider training, case transmission verification (CTV) and source data QC (SDQC) activities are performed as scheduled.

Perform monthly quality and evidence checks on the MAP GTT entries, address issues with business units and support their resolution in case of non-compliance.

Review MAP metrics monthly and lead follow-ups according to global processes if metrics are below their targeted KPIs.

Oversee and control correct closure of MAPs and remind relevant stakeholders to deliver their contribution on time.

Develop and maintain local MAP guidelines based on the global processes.

Lead, coordinate and collate data for quality checks conducted by the Global MAP team

Provide regular MAP status updates, highlight potential risks and escalate issues accordingly

Together with Local Quality Responsible, Local Safety Responsible, and MAP owners, ensure audit / inspection readiness for MAPs.

Key Activities /Responsibilities related to PSPs

Acting as the Cross Functional Process Owner for the PSP Process with several accountabilities: Owner for the process; single accountable person for the overall performance of the end –to-end process with oversight of the process. ; escalation point for process queries and suggestions for improvement; defining and reporting key process performance measures; ensuring all documentation and training for the process is available and up to date; ensuring all documentation and training for the process is available and up to date; ensuring that systems are supporting optimal process performance.

Driving a programme of continual improvement, raising or increasing awareness; knowledge and understanding of PSP, acting as a change agent and engaging relevant stakeholders.

Liaising with business/functional units and shaping the design of PSP programmes ensuring adequate collection of safety data and their timely reporting to safety unit as well as compliance with applicable company standards.

Acting as the point of contact in the Affiliate for communications in relation to PSPs

Monitoring PSPs to identify areas of risk and develop a strategy and action plan to ensure compliance.

Acting as MY Affiliate PSP point of contact to collate and provide data in the event of an audit or regulatory authority inspections.

Supporting drug safety and business units where required to determine appropriate CAPAs to any findings and ensure effective closure in a timely manner.

Others

Any other duties that may be assigned from time to time as required by the business.

Job Requirement

Expertise:

3 years in pharmaceutical/biotech industry with good understanding of Patient Support Programs and commercialization value chain and /or experience with Pharmacovigilance or Compliance related roles.

Good analytical and systems thinking. Has the ability to understand complex processes.

Can explain clearly and influence and persuade others. Obtains buy-in from stakeholders by using a range of persuasion techniques and actively networking.

Well-organised with good planning skills

Education / Qualification:

Minimum degree is Bsc Life Sciences

Excellent command of written and verbal English with good oral and written communication skills.

Process good knowledge in relevant statutory requirement pertaining to Pharmaceutical or related industry is preferred.

Demonstrated strength in agile working principles, methodologies and team structures.

Global working experiences and exposure is a plus.

Roche is an equal opportunity employer. Customer Support, Customer Support

Technical & Application Support
Apply To This Position

Save for Later

Sharing is Caring

Know others who would be interested in this job?