Bilingual Global Safety Associate

**HOW MIGHT YOU DEFY IMAGINATION?**

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

**Bilingual Global Safety Associate - (18 Month Contract)
- French/English**

Reports to: Global Patient Safety Sr. Manager

Remote work within Canada

**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 closer supervision of 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 and 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**:

- Translation of safety related documents 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 standard methodology

**Local Safety Affiliate Activities**:

- Maintains current knowledge of and compliance with local safety regulations for local country or countries
- Ensures that local safety activities are detailed, filed or archived in line with Amgen /GRAAS policies and procedures
- Assists in the training on adverse event reporting obligations for local customer-facing staff and others required by national practice or company policy
- Assists local Safety team with preparations for audits and 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
- Act as representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
- Other duties related to the position as defined in Standard Operating Procedures or as requested by supervisor

**Core Safety Affiliate Responsibilities**:

- Performs timely and accurate local processing steps for all adverse events reported to the local affiliate 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, while aligning with specific agreements or procedures
- Supports intake of product complaints, in countries where local safety is designated this activity

**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**:

- Raise 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. Product Monograph), 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
- Supports 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 bilingual professional we seek is an independent worker with these qualifications:
**Basic Qualifications**:

- BS/MS degree
- Bilingualism in French and English (written, verbal, oral)
- Ability to read shorthand

**Preferred Qualifications**:

- Experience translating between French and English
- Professional qualification as a health care professional (doctor, pharmacist, nurse, vet) or doctoral degree
- Experience in biotech/pharma industry, clinically based or regulatory agency role
- Growing understanding of le