Scientific Office & PV Manager

Johnson & Johnson Consumer is recruiting for Scientific Office &
Pharmacovigilance Manager to be located in UAE.
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:

This is a middle management role reporting directly into the Director of
Regulatory function managing Africa Middle East & Turkey (AMET), who is
currently based in Dubai, UAE. The purpose is to manage and coordinate all
aspects of Scientific Office affairs and Local Safety
Officer/Pharmacovigilance in UAE in compliance with the set forth regulations
in UAE and/or GCC countries. This role requires expertise in local compliance,
safety, PV, quality, i.e. a broad-spectrum of scientific affairs
This role will also require the individual to work in close collaboration with
R&D Regulatory Affairs, Pharmacovigilance/Safety organization, Local Business
partners/Distributors located in UAE and all competent Health Authorities in
UAE and/or other GCC countries.

Duties & Responsibilities:

• Manage and execute the UAE legislative responsibilities for the New Co. Scientific Office in accordance with internal strategies and taking into consideration all related business operational activities (including but not limited to New LE License application, approval acceleration, exceptional considerations (if applicable), all regulatory compliance, regulatory intelligence, internal & external stakeholder management] in UAE and/or other GCC countries to fulfill both business and regulatory requirements for the New Co. - currently known as the Johnson and Johnson Consumer Division


• Provide accurate pharmaceutical information about the company's products marketed in the UAE to the beneficiaries and health care practitioners and monitors pursuant to the scientific basis for practicing the pharmacy profession.


• Ensure that the information used for the marketing of registered company products is accurate and consistent with the written information approved by the competent Health Authorities in UAE.


• Ensure that the company represented by the office complies with the UAE Code for the ethics of OTC/pharmaceutical products marketing.


• Implementing the regulations and instructions issued by the UAE MOH&P & other respective Health Authorities.


• Support scientific activities in the fields related to the company's products available in UAE, participating in the activities of scientific associations and contributing to the continuous education programs.


• Contributing to the scientific studies and research in cooperation with the specialized scientific centers according to the research rules and ethics.


• Training company employees and pharmacy students to understand the functions of the scientific office.


• Following up the registration of the company & its respective products in UAE


• Contributing to health awareness and medicinal education in UAE.


• Complacent Management of Free Medical samples of registered products and storing them according to the technical storage principles.


• Following up and marketing the company's products after registration and reporting to UAE-MOH&P any observations regarding the quality and effectiveness, side effects or medication errors, after marketing within a maximum duration of:


• Serious/unexpected side effects reports:Within ‎15 days


• Not serious/unexpected side effects: Within ‎15 days


• Serious/expected side effects reports: Within ‎15 days


• Not serious/expected side effects: Within ‎90 days


• Pharmaceutical preparations quality: Immediately


• Lack of effectiveness reports: Within ‎15 days


• Support the attendance of health care practitioners at the scientific conferences.


• Follow up the update of the leaflet and external packaging of the registered products and ensure that information matches what is approved in the UAE.


• The scientific office shall establish a Department of Pharmacovigilance, with a full-time authorized pharmacist holding a license to practice and to perform his duties in accordance with the Guideline on Good Vigilance Practices.

Main performance measures (Performance Goals):

Good Regulatory Practices:
* Ensure the maintenance of accurate records (archives) of scientific office activities, licenses & respective company, and product registrations and/or documentation, as appropriate.
* Initiate development of best practices for All Scientific Affairs processes.
To develop networks and strong working relationships with regulatory
agencies and industry bodies:
* Liaise with regulatory agency personnel.
* Liaise with Regulatory Affairs personnel at local distributors to influence results
* Influence industry bodies to ensure Industry perspective is properly followed.
* Regular meetings with respective advocacy groups.
* Build and maintain excellent relationships with relevant regulatory bodies, external bodies, contractors and corporate partners which will have direct impact on the Company from Safety, PV, Quality, Regulatory perspective.
Build and develop networks and strong working relationships with internal
customers:
* To provide general scientific affairs & regulatory advice.
* To provide regular updates and reports.
* To specifically develop strong working relationships with Regulatory contacts and the business.
* To contribute to Local, Regional and Global process improvement.

Qualifications

Experience Required

• Education: Bachelor Degree in Ph. Sciences


• Experience; **** minimum ‎3 years of experience in regulatory affairs/ Health authority body or any other disciplinary organisations


• Language: Arabic and English is a must


• Location: UAE


• Relocation availability: NA

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.

Technical/Functional Skills Required

• Familiar with All Scientific affairs & Regulatory framework in UAE implemented by local Health authorities overlooking all health and medical practices including but not limited to legal entity creation, scientific office best practices; for all consumer product categories


• Familiar with local and international set standards for product compliance including product quality & safety


• Has experience in dealing with regulatory bodies and/or Health authorities, KOLs


• Can exemplify good track record in management of product quality & safety, regulatory statutory standards


• Has a strong capability to follow up & track work on global regulatory systems managed by the corporate to achieve regulatory statutory compliance, in relation to product quality/safety/PV metrics & KPIs
  Johnson & Johnson announced plans to separate our Consumer Health business
  to create a new publicly traded company. The process of the planned separation
  is anticipated to be completed within ‎24 months, and it will be subject to
  legal requirements including consultation with works councils and other
  employee representative bodies, as required, and other customary conditions
  and approvals.
  Should you accept this position, it is anticipated that, following
  conclusion of the transaction, you would be an employee of a new entity within
  New Consumer Health and your employment would be governed by New Consumer
  Health 's employment processes, programs, policies, and benefit plans. In that
  case, details of any planned changes would be provided to you by New Consumer
  Health at an appropriate time and subject to any necessary consultation
  processes.
  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 UAE are working to create an inclusive environment where
  diverse backgrounds, perspectives and experiences are valued and each and
  every one of our people feel that they belong and can reach their potential.
  No matter who they are.
  Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"!

Primary Location
United Arab Emirates-Dubai-Dubai-
Organization
Johnson & Johnson Middle East FZ-LLC (‎8608)
Job Function
Regulatory Affairs
Requisition ID
2206055195W