safety AssociateNovo Nordisk

Are you ready for an exciting role that will change patient's lives? We have an opening for a Safety Associate in Novo Nordisk Philippines.
Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases.
Reporting to: Director, Clinical, Medical, Regulatory, and Quality Affairs
About the Department : Clinical, Medical, Regulatory and Quality (CMRQ) Department is a team of skilled and committed specialists within medical, clinical, regulatory, quality and safety areas providing timely, accurate and updated services to empower Novo Nordisk in its therapeutic areas. All activities are built on our scientific acumen, strengths in business understanding, strategic thinking, creativity and innovation to be as effective as possible in the challenging pharmaceutical environment.
The position
As a Safety Associate, your responsibilities are as follows:
Acts as the main Local Pharmacovigilance Responsible Person (LPRP)
Local Requirements
TImley reporting of Adverse events externally to Local authorities(PhFDA) & internally to global safety
Updates local SOPs to ensure alignment with local laws and global cross-functional SOPs
Checks and updates the Global Safety (GS) Data Collection Tool accurately and in a timely manner
Provides affiliate organizational data
Provides accurate data for HALO-PV in a timely manner
Handling Customer Contacts and Safety Information
Main responsible for receiving and classifying customer contacts
Ensures quarterly Quality Control (QC) checking of customer contacts for any safety information
Reports identified Safety Information (SI) including technical complaints to headquarters within required timelines
Prepares reporting documents and ensures submission of safety information to local health authorities within required timelines
Ensures contact information for customers is available during out-of-office hours (e.g. instructions on what to do and who to contact)
Ensures a back-up system is in place and functional with clear roles and responsibilities
Oversight and Quality Control
Monitors and documents safety mailbox daily
Identifies related local PV regulations and keeps Safety Data Exchange Agreement (SDEA) with Global Safety updated
Acts as main responsible person during PV audits and inspections
Conducts PV on-boarding and refresher trainings to affiliate employees and contractual partners
Supports in Recall Process
Pharmacovigilance System Master File (PSMF)
Coordinates and ensures updated Safety Data Exchange Agreement with external stakeholders
Monitors local Patient Support Programs (PSPs) and Market Research Programs (MRPs)
Qualifications
A college degree in Pharmacy and is a licenced pharmacist
Additional experience in quality assurance/regulatory would be of advantage
Experience in Pharmacovigilance and drug information with a good knowledge of adverse event reporting requirements
Professional, self-motivated, team player, resilient, passionate, solution oriented in a dynamic environment
Possess effective communication and interpersonal skills
Philippines FDA QPPV training would be an advantage
Working at Novo Nordisk
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Contact
Please send your CV online (click on Apply and follow the instructions). Internal candidates are requested to inform your line manager.
Deadline
Until the completion of recruitment. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
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Novo Nordisk

Manila City, Metro Manila
Permanent
Full-time