Senior Safety Associate

**Join Amgen’s Mission of Serving Patients**:
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease
- we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. We have proudly achieved certifications as **Great Place to Work and Equidad MX**. Join us and transform the lives of patients while transforming your career.

**Senior Safety Associate (Pharmacovigilance)**

**Live**:
**What you will do**

**Key** responsibilities** include, but are not limited to**:

- Maintains own current knowledge of and compliance with local safety regulations for local country or countries.
- Works with Safety Country Lead to keep local affiliate safety requirements up to date in GPS SOPs and manuals, and reporting requirements.
- 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 customer-facing staff and others required by national practice or Company policy, also for relevant contractors, agents, business partners or distributors.
- Assists local Safety team during conduct of audits & inspections of safety operations and other PV interactions with local Regulators.
- Assists Safety Country Lead and local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors, and distributors, as applicable.
- Timely & accurate capture, routing, translation and follow up of adverse events reported in the local country(ies) for inclusion in the Global Safety database.
- Assists with timely submission of all reportable adverse event reports.
- Assists with distribution of periodic safety reports for local and/or regional needs.
- Assists with the dissemination of urgent safety communications, DHPCs and DILs required by Amgen decisions or Regulatory Agency demands, according to local requirements.
- Assists in safety screening of local medical literature.
- Facilitates exchange of adverse event information with functional service providers, distributors, or business partners, in line with specific agreements or procedures.
- Works with Safety Country Lead 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.
- May assist Safety Country Lead and local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors, and distributors, as applicable.
- May assist in safety review of protocols of local interventional, non-interventional studies (NIS) and independently sponsored studies to ensure safety monitoring and data collection are appropriately addressed.
- May assist in local safety review of plans / vendor contracts of local market research studies and patient support programmes to ensure safety contract language, training, monitoring, and data collection are appropriately addressed.
- May assist in review of local Amgen sponsored websites/social media projects, if used, to ensure appropriate compliance measures are implemented, for bring together of potential adverse events received.
- May assist in tracking dissemination of DHCPS, DILs and risk minimisation measures, such as physician education booklets.
- 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 vital as defined in Standard Operating Procedures or as requested by their supervisor.
- Raises product safety issues to Safety Country Lead.
- Develops expertise in one or more product or product classes.
- Maintains awareness of current prescribing information (eg. SmPC), investigator brochures and risk management plans to support product safety activities.
- Using expertise and with information from Product Safety Teams:

- May represent Safety in local medical meetings to discuss product safet