PV Hub Associate (12 months contract)

Job description

·  Job facts

Title: Pharmacovigilance Hub Associate-(APAC Regional Hub located in Singapore)

Department: Regional PV Hub (SG)

Reports to: Pharmacovigilance Hub Manager (APAC Regional Hub located in Singapore)

The PV Hub Associate be involved in the implementation of a positive wave of changes across the APAC 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 and will report into the APAC PV Hub Manager.

The position holder will be responsible for supporting PV activities within the PV hub coverage areas to ensure PV activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements.

Key Accountabilities

Performs accurate data capture of adverse event reports, for Roche products from Clinical trials, Post-Marketing Studies (PMS), Spontaneous Reports, Market Research and Patient Support Programs (MAPs), etc. associated with Company products onto the safety database in accordance with internal processes and local and international regulatory requirements Performs post surveillance activities such as literature review and media monitoring Performs reconciliation activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries and MAPs Assists and supports department with documentation management Performs and documents contact tests for drug safety to test the mechanisms of reporting to Local Safety Unit Responsible for keeping relevant databases up to date Supports the PV-hub team in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented. Participates in PV project work when necessary and when deemed appropriate by the PV Hub manager

Professional and Technical Requirements:

Education/Qualifications

·  Health Care Professional 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.)
·  Previous operational experience in Drug Safety/Pharmacovigilance (preferred)

Experience, Skills, Knowledge:

·  Strong knowledge of medical terminology
·  Knowledge of global Pharmacovigilance regulatory requirements
·  Ability to evaluate, analyze and interpret data and draw conclusions independently
·  Strong organization skills, detail oriented, ability to adapt to change
·  Effective team player, demonstrating initiative and accountability
·  Good interpersonal skills, builds strong sustainable and collaborative relationships with internal and external stakeholders, as well as effective collaboration with functional groups and management
·  Good communication skills, both written and verbal
·  Identify improvement areas 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
·  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 major Asian language preferred

·  Who we are

At Roche, 91,700 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 Diagnostics is committed to create a great place to work for its employees and in 2015 we have been accredited as Regional Best Employer Asia Pacific by Aon Hewitt. Individual Best Employer Awards were awarded in Singapore, Korea, China and India.

Roche is an equal opportunity employer.