Local Medical Safety Specialist, Deputy QPPV KSA

Johnson & Johnson Pharmaceutical is recruiting for Local Medical Safety
Specialist to be located in Riyadh, Saudi.
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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).
Duties & Responsibilities

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 develop local controlled procedures to cover local aspects of PV/Safety activities.

Pharmacovigilance and Vigilance Service Provision:

• Ensure the Pharmacovigilance and safety activities for non-medicinal products (e.g., medical devices) are performed satisfactorily as per the local regulations, as applicable, to ensure that the regulatory compliance is maintained at MAH.

Qualifications

Job requirements

Qualification & Experience
* Saudi citizen
* Minimum of ‎2-‎4 years' experience in a healthcare compliance role or similar
* Minimum Bachelor's degree in life science/ pharmacy
* Basic training in pharmacovigilance science
* Licensed by Saudi Commission for Health Specialties
* Proficiency in Medical terminology (local languages)

Knowledge & Skills

• Management skills of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences, epidemiology, and biostatistics.


• Good verbal and written communication skills, fluency in local language(s) and English language required


• Good in data analysis and reporting


• Proficiency in global and local SOPs


• Team player


• Ability to negotiate and communicate with internal and external customers.


• Ability to establish and maintain open relationships within the organisation and with authorities.


• Ability to manage multiple critical issues and work under pressure

Leadership Behaviors Required

• LIVE OUR CREDO: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose


• CONNECT: Builds internal and external relationships based on respect, Collaborates openly across boundaries and acts as a team player.


• SHAPE: Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change.


• Grow : Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes.
  For more than ‎130 years, diversity, equity & inclusion (DEI) have been part of
  our cultural fabric at Johnson & Johnson and woven into how we do business
  every day. Our commitment to respect the dignity and diversity of all is
  embedded in our Credo.
  We know that the success of our business depends on having the best talent in
  a workforce that reflects the diverse markets we serve around the world and an
  inclusive culture that values different perspectives and life experiences
  That is why we in Saudi Arabia are working to create an inclusive
  environment where diverse backgrounds, perspectives and experiences are valued
  and each and every one of our people feels that they belong and can reach
  their potential. No matter who they are.
  Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"!