Middle-East Pharmacovigilance (PV) Hub Specialist

Job description

  Job facts

We are at Roche investing in the support for the country safety staff and, in that context, are recruiting for a new role, the PV Hub Specialist. You will have an opportunity to be involved in the implementation of a positive wave of changes across the Middle-East sub-region that includes increasing regional support staff and a PV hub, enhanced talent development practices, a targeted change and communications program, and changes in how the global teams partner with the regions and affiliates towards mutual success.

You will be located in Dubai and report into the Middle-East PV Hub Manager.

You will be expected to lead a team of drug safety associates, and will be responsible for:

·  Supporting PV activities within the hub coverage areas to ensure activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements
·  Providing support to Local Safety Responsible (LSR) in oversight of risk management activities
·  Performing ICSR processing and quality checks as needed
·  Keeping relevant databases up to date
·  Supporting PV hub team in maintaining standards and implementing improvements
·  Participating in PV project work when deemed necessary
·  Ensuring audit and inspection readiness and effective CAPA development relevant to hub operational activities

You will be expected to adhere to the Roche Leadership Commitments: Embrace the Roche Leadership Commitments: a. Take a genuine interest in people; b. Listen carefully, tell the truth, and explain the why; c. Empower and trust people to make decisions; d. Discover and develop the potential in people; e. Strive for excellence and extraordinary results; f. Set priorities and simplify work; g. Congratulate people for a job well done.

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

To be successful in the role you have the following qualifications/experience:

·  Medical relevant Degree (e.g. Pharmacist, Registered Nurse, Bachelor of Science in Nursing, Physician assistant, Nurse Practitioner) or Life Science Degree (e.g. BSc Biology, BSc Neuroscience, etc.)
·  Appropriate experience in Drug Safety/Pharmacovigilance, with a minimum of 3 years' experience in operations role
·  Sound knowledge of global Pharmacovigilance regulations
·  Ability to evaluate, analyze and interpret data, and draw conclusions, independently
·  Strong organizational skills, detail oriented, ability to adapt to change
·  Effective team player, demonstrating initiative and accountability
·  Good interpersonal skills, ability to build strong sustainable and collaborative relationships with internal and external stakeholders, as well as effective collaboration with functional groups and management
·  Good communication skills
·  Ability to identify areas for improvement and provide creative problem solving in a complex process-focused environment
·  Ability to work under pressure and convey a sense of urgency
·  Ability to work across cultures, including in a virtual environment
·  Proven ability to demonstrate Roche Values (i.e. Integrity, Courage and Passion)
·  Experience in using Computerized systems and Office applications
·  Capable and willing to undertake international travel (approximately 10 to 20%)
·  Fluent in English - verbal and written, with a second language (Arabic) preferred
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