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**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 Integral 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

📌 Senior Safety Associate (Pharmacovigilance) (Xico)
🏢 Amgen
📍 Xico