Global Safety Associate

2 weeks ago

Montreal, Quebec, Canada Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?


You've worked hard to become the professional you are today and are now ready to take the next step in your career.

How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do.

It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Global Safety Associate - (12 Month Contract)

Reports to:
Global Patient Safety Manager

Location:
Remote work within Canada OR can work from Mississauga office in hybrid model

Live

What you will do
Let's do this. Let's change the world.

In this vital role you will conduct specific core safety activities for safety under close supervision of the Safety Manager.

This includes data collection, processing and distribution within the relevant local country/countries, based on appropriate training and assigned roles within the safety database and related systems.

You will help maintain compliance with local legislation, company policies, and assist in providing the full range of safety activities to support the local business, including safety training and providing safety information to local medical teams.


Responsibilities:

  • Receive, triage, evaluate and forward received domestic safety information to global safety hub in accordance with company's standard procedures and regulatory requirements
  • Perform appropriate followups with reporters, distribute safety related queries
  • Assess adverse events reports for expedited reporting to Health Canada and ensure reporting within required timeframes
  • Support the translation of safety related information from French to English or vice versa

Collaborative Activities:

  • Participates in global/ regional /country safety meetings
  • Provides input into Safety or cross functional initiatives, and if required, to develop best practices

Local Safety Affiliate Activities:

  • Maintains own current knowledge of and compliance with local safety regulations for local country or countries
  • Ensures that local safety activities are documented and filed or archived in line with Amgen /GPS policies and procedures
  • Assists in the training on adverse event reporting obligations for local customerfacing staff and others required by national practice or Company policy
  • Assists local Safety team with preparations for audits & inspections of safety operations
  • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
  • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by their supervisor

Core Safety Affiliate Responsibilities:

  • Performs timely & accurate local processing steps for all adverse events reported to the local affiliate, from all sources, to enable entry into the Global Safety Database
  • Assists in safety screening of local medical literature
  • Timely submission of all reportable adverse drug reaction reports & the distribution of periodic safety reports or urgent safety communications, as required by local regulations and Amgen procedures
  • Facilitates exchange of adverse event information with functional service providers or business partners, in line with specific agreements or procedures

Compliance Activities:

  • Works with Safety Manager to maintain required standard of local operating performance and reporting compliance for AE case and periodic safety reports
  • Participates in resolution of local issues that occur, through CAPAs and related activities
  • Ensures local quality assurance measures to maintain inspection readiness of local safety function

Therapeutic Area Safety Support:

  • Escalates product safety issues to local Safety Manager
  • Develops expertise in one or more product or product classes
  • Maintains awareness of current prescribing information (e.g. SmPC), investigator brochures and risk management plans to support product safety activities

With support of Safety Manager and information from Therapeutic Safety Teams:

  • Represents Safety in local Medical meetings to discuss product safety issues
  • Provides responses to internal and externally sourced safety questions
  • Provides product safety training to commercial or medical colleagues
  • Assists the Safety Manager to support the local implementation of risk minimization activities associated with approved risk management plans

Win

What we expect of you
We are all different, yet we all use our unique contributions to serve patients.

The detail oriented professional we seek is an independent worker with these qualifications:

**Bas

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