Sr Assoc Pharmacovigilance Operations
About this opportunity
Career Category
Safety
Job Description
Job Summary
Responsible for:
Support vendor oversight of all case intake and processing activities
Case review
Escalation of case level issues
Support convention-related training delivery
Manage queries on Intake, triage, and data entry of ICSRs
Reporting decision for submitting all expedited safety reports to FDA/EMA
Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
Reporting of ICSRs within time frames determined by regulations and contracts
Support BP reconciliation as required by safety agreement
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Be representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor.
Key Activities
Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements
Perform case review
Perform US case follow up activities
Support the development and delivery of convention-related training material
Review and respond to AE intake, triage, and submission queries in a timely fashion
Initiate unblinding as requested
Select cases for reporting to FDA/EMA and business partners based on detailed knowledge of legislation & contractual agreements
Ensure compliance of reporting activities with timelines and criteria
Interface with local office staff, vendors, and business partners for case processing as necessary
Escalation of data entry issues identified
Provide LAO E2B support (nullification, redistribution)
Perform BP reconciliation as required by safety agreement
Support the ICSR literature review process
Support reportable event reconciliation for Amgen-sponsored clinical trials.
Support other case processing functions as required.
Knowledge and Skills
Understanding of global regulatory requirements for pharmacovigilance
Familiarity with clinical development process
Case processing experience with demonstrated high case level productivity and quality
Attention to detail
Proficiency in safety system
Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
Education & Experience (Basic)
Bachelor’s degree and 2 years of directly related experience
OR
Associate’s degree and 6 years of directly related experience
OR
High school diploma / GED and 8 years of directly related experience
.
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 28 comparable Senior Pharmacovigilance roles across 17 biopharma companies.
Salary context
8 of 28 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 28 comparable roles
+ 6 more countries
Seniority mix
28 of 28 peers have a known seniority level
Therapeutic area mix
2 of 28 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.
Notify me about similar jobs
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.