Senior Associate Safety Data Analyst
About this opportunity
Career Category
Engineering
Job Description
Group Purpose:
This group supports pharmacovigilance activities through the maintenance, development and continuous improvement of the global safety system and the provisioning of high-quality data outputs/visualizations.
Job Summary:
Support changes to the global safety system and associated Datamart
Support the implementation of global safety system configurations
Support accurate clinical trial safety data collection in the global safety system
Key Activities:
With limited direction from Sr. Manager-Safety Data Analyst (SDA), the Sr. Associate - SDA may perform the following activities:
Generate outputs from the global safety system in support of periodic safety reports (e.g., PADER, PSUR, DSUR)
signal detection
audits, inspections and regulatory inquires
Ensure delivery of automated/scheduled safety data outputs
Perform Quality Checks/Peer Review as needed for data outputs and routine system configurations
Participate in collecting business requirements for routine safety data outputs
Participate in the implementation of routine system configuration including reporting rule updates, product and study configuration
Augment and/or define search strategies in collaboration with leads to ensure consistent data outputs
Support study startup activities such as RAVE-Argus mapping User Acceptance Testing (UAT), Mapping Specifications Worksheet (MSW) approval
Participate in user UAT of safety system changes
Contribute to the development and maintenance of technical solutions to support safety system and data outputs
Participate in the development and delivery of training related to safety database and tools
Assist in the development of system support related quick reference guides.
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Support Authority Inspection and Internal Process Audits within the remit of role and responsibility
Knowledge and Skills:
Knowledge of safety systems (LifeSphere MultiVigilance platform/Argus) as well as query and reporting tools e.g. Cognos, Tableau
Understanding of data warehouse concepts and data mining techniques
Understanding of software development lifecycle and development standards, including validation methodology
Understanding of global regulatory requirements for pharmacovigilance and safety reporting
Understanding of Clinical Trial and Pharmacovigilance Processes
Familiarity with statistical analysis and interpretation of aggregate safety data
Organization, prioritization, planning and measurement of work deliverables
Ability to build relationships and work cross-functionally
Work independently and proactively; recognize and escalate issues
Pharmaceutical industry or health authority experience.
Experience in supporting inspections or internal audits
Education & Experience (Basic):
Master’s degree
OR
Bachelor’s degree and 2 years of directly related experience
OR
High school diploma / GED and 8 years of directly related experience
Education & Experience (Preferred):
Work experience in biotech/pharmaceutical industry
Database support work experience
Understanding of clinical trial databases such as Rave/Veeva EDC
Understanding of integration between clinical trial databases and safety databases
.
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 18 comparable Senior Pharmacovigilance roles across 10 biopharma companies.
Salary context
4 of 18 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 18 comparable roles
+ 2 more countries
Seniority mix
18 of 18 peers have a known seniority level
Therapeutic area mix
1 of 18 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.
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.