Regional CSS Lead, AfME
Pfizer
Dubai, United Arab Emirates
منذ 12 يوم

ROLE SUMMARY :

Pfizer has a scientific, ethical, regulatory, and legal obligation to collect and evaluate safety information that may be associated with its products.

The mission of Pfizer CEP & CIT Support Services (CSS) organization is to help the business maximize the value of Customer Engagement Programs* (CEPs), Social Listening Programs (SLPs) and Customer Interaction Tracking (CIT) tools , while securing compliance to safety reporting and ensuring patients’ safety.

The vision of the CSS organization is to deliver thought leadership and fit-for-purpose services to ensure customer interactions are a competitive advantage for Pfizer by :

  • Balancing business value and risk
  • Driving quality to enable compliance
  • Optimizing operational efficiency.
  • As Pfizer continues to explore new commercial models and exponential increases in the adoption of digital and social media channels in the midst of a tough regulatory environment, managing CEPs, SLPs and CIT tools effectively is extremely important.

    The CSS Lead is the single point of contact for Country Management Forum for all Customer Engagement Programs (CEP), Social Listening Programs (SLP) and Customer Interaction Tracking Tools (CIT).

  • The CSS Lead manages the end-to-end process from design, development, approval, execution and close-out of Customer Engagement and Social Listening programsand CIT Tools in country / cluster to ensure compliant application of CEP, SLP and CIT tool processes by the business;
  • scope includes all marketers for CEPs and SLPs and all field force colleagues for CIT tools across all therapeutic areas.

  • The CSS lead acts as a local champion and subject-matter expert in managing end-to-end CEP, SLP and CIT tool processes to ensure compliance and improve quality;
  • collaborates closely with Regional CSS Lead as first point of contact and escalation point; and serves as Single Point of Contact for all local stakeholders representing CSS in approval meetings and other forum to raise awareness of CSS and build a culture of quality and compliance.

    The CSS Lead will oversee all aspects of audit and inspection readiness and lead the implementation of Corrective and Preventive Actions (CAPAs) and issue resolution.

    The CSS Lead will also drive vendor excellence activities, delivery and completion of training activities and act as local champion in implementation of regional and global CSS projects and initiatives.

  • Customer Engagement Programs (CEPs) are programs sponsored by business units and divisions at the global, regional or country levels, in which there is the potential for two-
  • way communication between Pfizer or a vendor acting on Pfizer’s behalf and customers (e.g. patients and healthcare providers) through which Adverse Events and / or other reportable safety information may become evident.

    Some examples of CEPs are :

  • Digital media (mobile apps, interactive internet sites, social media)
  • Interactive webcast
  • Patient Support Programs
  • Call centers
  • Disease awareness / screening
  • Pfizer-sponsored philanthropic programs
  • Market research
  • Email or texting programs
  • Direct mail with business response card
  • Social listening programs are programs through which Pfizer collects, monitors, and analyzes content from a variety of social media platforms (e.

    g., Twitter, Facebook, Snapchat, LinkedIn, YouTube, Instagram) in order to learn about customer attitudes and experiences regarding a company, its products or other areas of interest (e.

    g., diseases, conditions, or indications).

    Customer Interaction Tracking (CIT) tools are broadly defined as any structured electronic collection of (healthcare) interaction records used by more than one commercial customer-

    facing colleague (e.g. CRM systems used by customer-facing colleagues to report activity).

    ROLE RESPONSIBILITIES :

  • Expert for any CSS Policies
  • Act as single point of contact and local subject-matter expert for country management fourm to drive overall culture of quality and compliance of CEPs, SLPs and CIT tools within country / cluster
  • Closely collaborate and engage with Regional CSS Lead as first point of contact for guidance and escalation point to drive compliance in country / cluster across all CSS policies , identify opportunities for improvement and share best practices
  • Partner with CSS Business Process Owners / Global CSS Center of Excellence to implement CSS policies and strategies in country / cluster, as well as oversee changes in local regulations relevant to CSS
  • Foster strong partnership with Business Units, Commercial Operations, Safety, Medical Quality Oversight etc. to represent CSS as a thought leader in country / cluster meetings and forums and demonstrate value proposition of CSS
  • Provide inputs on CEP, SLP and CIT volume forecasts to improve demand management in collaboration with global CSS Center of Excellence
  • Design and implement local operating plan in collaboration with the global CSS Center of Excellence
  • Local CSS Process Ownership and Quality Monitoring
  • Manage end-to-end process from design, development, approval, execution and close-out of all CEPs, SLPs and CIT tools in country / cluster to ensure compliance with Pfizer policies
  • Act as a subject-matter expert providing in-depth knowledge and consultancy to CEP, SLP Owners and CIT Tool Owners to design programs and tools appropriately to ensure compliance
  • Chair and facilitate local committee approval meetings and any other additional meetings between Program / Tool Owners and local approvers to secure agreement on programs and tools for timely approval
  • Drive consistent quality standards and effectiveness measures across CEP, SLP and CIT tools in line with global quality plans and quality by design guidance
  • Lead benefit, cost and risk assessment activities in country / cluster to support the business in making informed investment decisions on CEP, SLP and CITs
  • Ensure appropriate escalation of risks and issues to Regional CSS Lead as well as provide timely status updates and reports to CMF and other stakeholders.
  • Audit and Inspections
  • Oversee all aspects of audit and inspection readiness and liaise with CSS Quality Implementation Global Center of Excellence to drive clear and consistent communication, documentation, training, inspection readiness plans, processes and controls
  • Proactively drive awareness and upskill Program Owners and Tool Owners to fulfill their role during audits and inspections
  • Monitor country / cluster audit and inspection outcomes, support development of any necessary remediations, share learnings and flag areas of concern,
  • Lead effective implementation and management of Corrective and Preventive Actions (CAPAs) as per Pfizer’s requirements
  • Continuously monitor CAPA performance within country / cluster in collaboration with Regional CSS Lead and act as expert on CAPA remediation in collaboration with local Medical Quality Oversight organization
  • Oversee CEP, SLP and CIT reporting, with support from Local CSS Operations Support Manager where possible, and actively follow up with Program and Tool Owners to resolve any compliance issues as well as resolve outstanding issues with correspondent functional areas (e.
  • g. Regulatory, Legal, Compliance)

  • Responsible for escalating any compliance issues and appropriate reporting to Regional Quality Forum
  • Vendor Oversight
  • Drive vendor excellence and work in partnership with the business and global CSS Center of Excellence to assess, evaluate and maintain accurate vendor performance data and preferred vendor lists
  • Ensure that vendors not complying with CEP processes and requirements are identified and define applicable CAPAs
  • Oversee CEP vendor management and procurement systems, where possible
  • Training
  • Leadtraining and upskilling of key stakeholders including CEP and SLP Program Owners, CIT Tool Owners, vendors, approvers, marketers and field force colleagues to increase understanding and awareness of CEP, CIT, SL Policies and CSS processes and enhance compliance, quality and pharmacovigilance capabilities, in line with Global COE guidance.
  • Be accountable for monitoring and facilitating local training completion of mandatory CEP, SLP and CIT training courses among training audience, in collaboration with the business and enabling partners.
  • Lead on local training audience maintenance processes in line with Global COE guidance
  • Provide feedback to global CSS BPO / Training COE Lead on training asstes, process and communication effectiveness
  • Best Practice and Continuous Improvement
  • Act as local champion to drive implementation of global and regional CSS projects and initiatives
  • Engage actively with the broader global CSS community and Center of Excellence to exchange best practices and lessons learned and promote collaboration across countries.

    QUALIFICATIONS : Qualifications

    Qualifications

  • Bachelor's degree required
  • Min. 5+ years of professional experience; which includes 3+ years in CEP / CIT or transferrable experience
  • Demonstrated work experience in Commercial operations, Safety and / or Compliance
  • Detail-oriented with strong organizational skills and a proven ability to prioritize and work independently to complete quality work on a timely basis
  • Ability to work effectively and collaboratively with global partners e.g. CEP / CIT Centers of Excellence
  • Experience in commercial operations and / or sales & marketing is considered as a plus
  • Skills and Knowledge

  • Understand the fundamentals of drug safety and risk management (e.g. Adverse Event reporting), CEP processes, policies and procedures
  • Strong analytical skills; ability to analyze information, draw insights and recommend improvements; ability to synthesize problems and develop innovative solutions and strategies
  • Ability to demonstrate strong facilitation and collaboration skills
  • Proficient in project management skills
  • Proven ability to drive execution of strategies
  • Proficient in common technical tools (e.g. Microsoft Office)
  • Strong written and oral communication skills
  • Ability to build strong formal and informal relationships
  • Language skills : fluent in local language and English
  • Organizational Relationships

  • Cluster / Country commercial leadership teams and leadership
  • Regional CSS Leadership
  • Global CSS Center of Excellence
  • Cluster / Country CO leadership
  • Cluster / Country Functional teams and Leadership (Global Busness Analytics, Medical Quality Oversight, Drug Safety, BT, Corporate Compliance, etc.)
  • This role will travel if necessary to ensure the achievement of the set objectives.

    The role will manage two to three employees (headcount and contracted).

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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