Scientific Office

2 days ago

Dubai, United Arab Emirates Johnson & Johnson Full time

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:
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, c

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