Cross-sector Local Medical Safety Specialist

2 weeks ago

Riyadh, Saudi Arabia Johnson & Johnson Full time

Johnson & Johnson is recruiting for a Cross Sector Medical Safety Specialist to be located in Riyadh, KSA.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

**Summary of the job**:
The employee is responsible for supporting Pharmacovigilance related activities in the region and as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable. Also, he/she will ensure the maintenance of an appropriate Pharmacovigilance system and Risk Management to assure appropriate oversight for products within the scope of responsibilities.

The employee will act as a Nationally Nominated Person for Pharmacovigilance in KSA (Deputy QPPV).

**Local Medical Safety Responsibility & Benefit Risk Management**:

- Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or Medical Safety Officer (MSO) and the Country Safety team lead (CSTL)/Local Safety Officer (LSO).

**Aggregate reports**:

- Support in providing insights for aggregate reports while undertaking local review and ensure the preparation and submission of Periodic Safety Update Reports (PSURs/DSURs), as applicable.
- Being involved in the ICSR causality assessment and submission to the local health authority, as applicable.

**Pharmacovigilance-Safety training support**:

- Support in the preparation & delivery of Pharmacovigilance training for Local Operating Company employees, and Adverse Event and Product Quality Complaints (AE/PQC) trainings to distributors/vendors and with the translation of AE/PQC material, where needed.

**PV contract management**:

- Support in the local Pharmacovigilance Agreements (PVAs) preparation and implementation, including Local Safety Unit (LSU) training and adherence to PVAs.
- Support in the regular monitoring of the PV compliance activities performed by the commercial qualified distributors and able to identify trends or significant issues that appropriate actions.
- Coordinate the provision of support for third party safety agreements e.g., local Vendor Agreements as necessary, seek support from central functions like PV Service and Technical Contracts Group and International PV (IPV) Affairs, as necessary.

**Safety regulations**:

- Escort in detecting and reporting PV regulatory requirements for MAH,
- Support in the review of new/revised safety regulations (for drugs, non-medicinal products & Medical Devices in scope of responsibilities), the impact on the local processes and notification of appropriate global and regional groups via the central PV policy tracker (new requirements and or updates), as required.

**Local Safety compliance**:

- Prepare and develop the Pharmacovigilance System Master File (PSMF) to fulfil the local regulations and ensure it maintains accurate and up to date.
- Support with CAPA end to end process such as but not limited to, identification, investigation of compliance issues, development, and implementation of corrective and preventive actions
- Support QPPV KSA/LSO in local regulatory requirements such as Health Authority Query, Safety Issues and Signal management, as needed.

**Inspection preparation & Support**:

- Ensure PV audit/ inspection readiness on the LOC level
- Act as the local PV contact person for local PV audit and inspection.
- Assist inspectors / auditors, support document requests in collaboration with different key stakeholders.

**Business Continuity**:

- Support in the creation and implementation of a PV local business continuity plan.
- Ensure an effective PV system is in place for 24-hour coverage.
- Ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained at the LOC level.

**Procedural Document design**:

- Ensure implementation of Global Pharma and Consumer Cross-Pharma PV relevant Procedural Documents as applicable and/or write, validate, and implement the Local Implementation Documents (LID) for Regional / International PV Standard Operating Procedures/Working Practices and verify adherence. Where appropriate d

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