Patient Safety & POP Governance Manager

Job Description

Job Purpose :

Drive the end-to-end POP (primarily Patient Support and Market Research Programs) process and governance in the respective country organization, or assigned cluster of countries

Ensure the local implementation of the Novartis POP standards, policies, guidelines and processes

Assess local risks for Novartis related to POPs and establish risk mitigation plans

To manage the Patient Safety operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations / standards / guidelines for the vigilance of Novartis group approved, marketed and investigational products (incl. drugs, food supplements and medical devices). To support the CPSH in the implementation of PS strategy at country level.

Major Accountabilities :

1. To be the accountable for specific operational vigilance process(es) at the Country Organiza-tion (to be detailed here)

2. To mentor less experienced staff, maintaining a professional network of key contacts and role model Novartis values and behaviors.

3. [If applicable] Act as the deputy of the Local Qualified Person for Pharmacovigilance / Local PV Responsible Person in Novartis Country Organization, as defined by local regulation and applicable legislation.

4. [If applicable] Act as deputy of the Country Patient Safety Head,

• functional (in terms of re-sponsibility for PV system) and operationally (in terms of management of the PS Team)

5. Ensure oversight and compliance in terms of reporting / submission / distribution of safety re-ports / updates / information (e.g., SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk-benefit pro-file) to Local Health Authorities (LHA) according to regulatory requirements and Novartis pro-cedures.

6. Work in close collaboration other local and global medical safety functions to ensure accurate evaluation of safety data.

7. Interact and exchange relevant safety information with Health Authorities, other functional groups, third-party contractors, and PS associates, as applicable.

8. Monitor national pharmacovigilance regulations and provide update to global PS organization.

9. Set up, update, and implement local procedures to ensure compliance with PS global proce-dures and national requirements.

10. Ensure local PS-related RMP commitments are executed and properly documented

11. Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.

12. Act as a key partner who provides input, during the process of establishing local programs (ex. POPs, DEAs; SM / SML, etc.) : comments on proposals for vigilance language, content, and es-tablishment of necessary controls on collection and reporting of adverse event information.

13. Ensure that relevant local literature articles are screened as appropriate.

14. Supervision of management and maintenance all relevant PS databases.

15. Ensure timely preparation and submission of KPI reports on AE reporting or AE follow-up including identification of root cause(s) e.g., for late reporting to HA, missed or delayed follow-up attempt, development and implementation of corrective and preventative action(s) as needed.

16. Support in developing and updating training materials for pharmacovigilance and ensure training of Country Organization associates on relevant PS procedures for AE reporting, includ-ing field force and third-party contractor, if applicable.

17. Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections.

18. Other agreed tasks assigned by manager.

19. Responsible for the full implementation of the Local POP Governance Framework which enables the end-to-end POP process, embeds Medical, Quality, Patient Safety, Regulatory, Ethical, Risk and Compliance requirements and facilitates cross functional stakeholder involvement. at the same time, ensuring alignment with local laws and regulations

20. Provide guidance and support for local associates involved in POPs throughout the program lifecycle; Develop and deliver training for local associates and management to ensure standards are well understood and followed by all associates.

21. Manage and oversee all Governance and POP monitoring activities at country organization or assigned cluster of countries.

22. Lead the Local POP Governance Board or equivalent body ensuring timely and comprehensive review of programs and POP related issues.

23. Proactively identify quality and compliance risks, establish mechanisms to mitigate these risks in collaboration with risk experts and Implement controls to measure compliance; review audit outcomes and perform country self-assessments as needed. Escalate issues if necessary to the GGO and local senior management.

24. Participate in cross-functional initiatives, global task forces and project teams. Act as an integral member of local implementation team, working closely with key stakeholders to drive POP strategy and implementation in the local organisation (e.g, One PSP, Project Enhance etc)

25. Support preparation for of health authority inspections, internal audits related to POPs, as needed

26. Be an ambassador for the Novartis values and behaviours and support the journey towards an inspired, curious, unbossed and self-aware organization

27. Establish and maintain effective communication channels with global and local teams and senior leaders at Novartis, to continuously enhance the Novartis POP standards and share best practices.

28. Support the / Chief Medical Office in the development and implementation of the Novartis POP standards, policies, guidelines, and procedures.

Key Performance Indicators :

1. POP standards are implemented locally, and POPs are executed in a compliant way; potential risks are identified and mitigated

2. Health Authority inspections and internal audits have no critical POP findings due to lack of local governance

3. Organisation, quality management and efficiency of vigilance processes

4. Country Organization AE reporting compliance

5. Results of self-assessments, audits and inspections

6. Internal and external customer satisfaction

7. Compliance with VA requirements

8. Compliance with RMP commitments

9. Efficiency in transfer of activities during acquisitions and divestments

10. Quality and timely responses to local health authority queries

Commitment to Diversity & Inclusion :

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education :

Master’s degree in science

Doctor of Medicine (M.D.) or Pharm D. is a plus

Languages :

Experience / Professional Requirement :

Division

Global Drug Development

Business Unit

Patient Safety & Pharmacovigilance

Country

Morocco

Work Location

Casablanca

Company / Legal Entity

NOV PHARMA MAR

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

Early Talent