Sr. Patient Safety Specialist
About this opportunity
Accountabilities
Maintain an effective local PV system compliant with local regulations and Good Pharmacovigilance Practice (GVP), including inspection readiness and business continuity.
Maintain and govern local patient safety procedural documents and ensure accurate local contributions to the Pharmacovigilance System Master File (PSMF).
Provide advanced operational oversight across PS processes, risk management, vendor oversight, and cross-functional collaboration.
Manage health authority interactions and ensure robust quality management, including CAPA, training, and documentation control.
Lead or mentor local PS staff and support local/global projects, analytics, and continuous improvement initiatives.
Responsibilities
Regulatory Intelligence and Governance
Maintain in-depth knowledge of local PV regulations and guidance; update regional lead and local teams on changes and escalate to Global Patient Safety as required.
Ensure local PV information is correctly reflected in the PSMF. Keep marketed status, Product Information/core data sheets, and safety commitments/conditions of use up to date.
Maintain and periodically review local PS procedural documents and related governance records (organization charts, job descriptions, CVs, training matrices/records).
Patient Safety Operations and Compliance
Oversee ICSR processing from clinical and post marketing sources via monthly quality control, and timely submission of ICSRs and follow-ups to health authorities.
Support timely, compliant submission of other safety documents (e.g., PBRERs/PSURs, DSURs, signals, SUSARs, RMPs, DHPCs) to health authorities per local requirements.
Manage monthly patient safety compliance data and ensure accuracy, completeness, and timeliness of PV data submitted to authorities.
Systems, Data, and Reconciliation
Maintain proficiency and oversee use of global PS systems and tools (e.g., Argus, Orbit, MyTime Portal, VQV, Nominated Signatory Portal, Cover, ERV, Veeva CRM, ECMS, Digital Assets Portal, PAL, Learning Management System).
Manage reconciliation processes (e.g., Organised Data Collection Programmes, Medical Information, Product Quality Complaints, Medical Science Liaison insights via Veeva free text) to ensure data transferred/received are accurate and complete.
Support development and use of reporting tools, dashboards, and analytics to monitor KPIs and identify operational improvements.
Risk Management and RMP Implementation
Support creation, implementation, and maintenance of local RMPs and risk minimization activities in collaboration with cross functional teams; oversee educational materials associated with RMPs.
Maintain awareness of conditions of use, obligations, and other safety commitments, ensuring local fulfillment and documentation.
Quality Management, Audit/Inspection, and CAPA
Support local SOPs and work instructions are in place, current, and aligned with global procedures; maintain filing and archiving practices for PS documentation.
Support audit and inspection readiness and execution; respond to findings and manage corrective and preventive actions (CAPA) through effectiveness checks.
Support annual update and testing of the local Business Continuity Process (BCP).
Maintain an after-hours AE reporting process for customers and authority queries.
Health Authority and External Interface
Support managing interactions and queries from health authorities (e.g., ICSR-related inquiries, signals, RMP related educational materials); ensure prompt, complete responses.
Support external patient safety service providers to meet AZ and local regulatory PV requirements.
Oversee local safety management agreements; maintain Pharmacovigilance Agreement Listings (PAL).
Training, Mentoring, and Development
Deliver or support delivery of PS training for local staff and vendors, including onboarding and annual refreshers; complete all required PS training personally.
Cross Functional Collaboration and Projects
Establish strong relationships and collaborate with Regulatory, Medical, Quality, Marketing/Sales, Clinical Operations, and other internal/external stakeholders to meet PS requirements.
Support patient safety projects at local and, as applicable, global levels (e.g., new regulations readiness, system/process rollouts); ensure conduct consistent with AstraZeneca values, Code of Conduct, and relevant policies and standards.
Date Posted
01-Oct-2026
Closing Date
15-Oct-2026
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Job details
How this role compares
Computed from every other active Pharmacovigilance role in our database, not just this employer's listings.
We currently track 31 comparable Senior Pharmacovigilance roles across 15 biopharma companies.
Salary context
8 of 31 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 31 comparable roles
+ 7 more countries
Seniority mix
31 of 31 peers have a known seniority level
Therapeutic area mix
3 of 31 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.