Professional Resume Template for
Pharmacovigilance Specialist
Sarah L. Jenkins
Boston, MA
(617) 555-0143
sarah.jenkins@email.com
linkedin.com/in/sarah-jenkins-pharmacovigilance | github.com/sarahjenkins | sarahjenkins.dev
Professional Summary
Methodical Pharmacovigilance Specialist with 6 years of experience managing global drug safety databases and adverse event reporting across clinical trials and post-marketing sectors. Expert in FDA and EMA regulatory compliance, safety narrative authorship, and MedDRA coding conventions. Successfully reduced case processing cycle times by 25% while maintaining a 99.8% regulatory submission compliance rate.
Work Experience
Pharmacovigilance Specialist — Beacon BioPharma
Boston, MA | January 2024 – Present
- Processed and triaged 1,400+ serious adverse event (SAE) cases annually using Oracle Argus Safety, consistently meeting 7-day and 15-day expedited reporting deadlines.
- Authored 120+ clinical safety narratives and Periodic Benefit-Risk Evaluation Reports (PBRERs), reducing documentation draft cycle time by 20% over 6 months.
- Facilitated a database optimization project that automated case intake classification, cutting manual data entry error rates from 4.2% to 0.8%.
- Assisted in audit preparation for 2 FDA pharmacovigilance inspections, resulting in zero major observations and complete system validation compliance.
Drug Safety Associate — Vanguard Clinical Research
Cambridge, MA | August 2021 – December 2023
- Coded 3,200+ adverse events, medical histories, and medications using MedDRA and WHO Drug dictionaries for 4 simultaneous Phase III clinical trials.
- Conducted daily reconciliation of adverse event databases against clinical trial databases, resolving 180+ safety-related data discrepancies.
- Trained 8 junior safety database users on standard operating procedures (SOPs) and EudraVigilance case submission criteria.
- Compiled data summaries for 6 Development Safety Update Reports (DSURs), enabling timely annual review and submission to the EMA.
Education
Doctor of Pharmacy (PharmD)
Northeastern University · Boston, MA · 2020
Skills
Adverse Event (AE) Case Processing, Oracle Argus Safety, ArisG, MedDRA Coding, WHO Drug Dictionary, FDA 21 CFR, EMA GVP Guidelines, Safety Narrative Writing, PBRER & DSUR Preparation, Clinical Trial Safety, Signal Detection, Audit Readiness, SOP Development, Data Reconciliation
Projects
Safety Database Migration
Role: Lead PV Specialist
Tools: Oracle Argus, Veeva Vault, SQL
Managed the validation and migration of 15,000 legacy adverse event records to a new safety database, finishing 3 weeks early with 100% data integrity.
SOP Alignment Initiative
Role: Lead Author
Tools: SharePoint, MS Visio
Revised 15 global pharmacovigilance standard operating procedures to align with updated EU GVP modules, improving audit compliance scores by 18%.
Certifications
- DIA Safety and Pharmacovigilance Professional Certificate (2023)
- Registered Pharmacist (RPh), Massachusetts Board (2020)
Additional information
- Languages: English (Native), French (Conversational)
- Memberships: International Society of Pharmacovigilance (ISoP), Drug Information Association (DIA)
- Availability: 3 weeks notice
Job Market Insights
Market data and opportunities for
Pharmacovigilance Specialist
Job Market Insights
$75,000
-
$118,000
Avg:
$94,000
Growth Outlook:
The demand for Pharmacovigilance Specialists in the United States remains robust, driven by the expanding drug pipeline, stricter safety regulations from the FDA, and the rise of complex immunotherapies. As companies shift from manual data entry to automated case processing systems, Specialists will increasingly focus on high-level signal detection, risk management, and regulatory audit readiness. Employment in related medical science roles is projected to grow by 9% over the next decade.
9% growth over 10 years
Key Skills Required
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