Pharmacovigilance Specialist Resume Example
Safety-signal layout: a caution-triangle mark, case-processing and compliance metrics and a safety-operations table for pharmacovigilance and drug-safety specialists.
Use this example Template: Pharmacovigilance Specialist
Katarzyna Nowak
Senior Pharmacovigilance Specialist — ICSR, Signal Management & PSURs
katarzyna.nowak@example.com+48 601 555 284Warsaw, Polandlinkedin.com/in/katarzynanowak-pv
8Years in drug safety
22,000Cases / year
18Signals evaluated
99.6%On-time E2B
Summary
Pharmacist and pharmacovigilance specialist with 8 years at a global CRO and an innovative pharma company. I lead case processing for marketed and clinical-trial products, perform medical review of serious ICSRs, run signal detection and evaluation in EudraVigilance and Argus, and author sections of PSURs and RMPs. My team processes 22,000 cases a year with 99.6% on-time E2B submission, and I have handled two regulatory inspections with no critical findings.
Experience
Senior Pharmacovigilance Specialist
Polpharma · Warsaw
Jan 2021 – Present
22,000Cases / year
99.6%On-time E2B
0Critical findings
- Lead a case-processing team of 7 for 140 marketed products: triage, MedDRA coding, causality and expectedness, follow-up and E2B(R3) submission
- Perform medical review of serious and fatal ICSRs and write company comments in line with GVP Module VI
- Run monthly signal detection in EudraVigilance (eRMR) and Empirica; evaluated 18 signals, 3 leading to SmPC updates
- Author safety sections of PSURs/PBRERs and RMPs; supported two national inspections with zero critical findings
Drug Safety Associate
IQVIA · Warsaw
Mar 2017 – Dec 2020
12Sponsor studies
- Processed SAEs and SUSARs for 12 oncology and immunology trials, including reconciliation with clinical databases
- Wrote 30+ DSURs and line listings; trained 9 new associates on Argus and MedDRA
- Prepared aggregate safety data for 4 DSMB meetings and supported unblinding requests
Community Pharmacist
DOZ Apteka · Warsaw
Sep 2015 – Feb 2017
- Dispensed prescriptions, counselled patients on interactions and reported adverse reactions to the national authority
- Ran the pharmacy's medicines-use reviews for patients on 5 or more chronic medicines
Safety operations (last 12 months)
| Activity | Volume | Compliance |
|---|---|---|
| Serious ICSRs (15-day) | 6,800 | 99.6% |
| Non-serious ICSRs (90-day) | 15,200 | 99.8% |
| Signals evaluated | 18 | On schedule |
| PSURs / PBRERs | 11 | 100% |
| Literature screening | Weekly | 100% |
Summary example
Pharmacist and pharmacovigilance specialist with [N] years at a global CRO and an innovative pharma company. I lead case processing for marketed and clinical-trial products, perform medical review of serious ICSRs, run signal detection and evaluation in EudraVigilance and Argus, and author sections of PSURs and RMPs. My team processes [N] cases a year with [X%] on-time E2B submission, and I have handled two regulatory inspections with no critical findings.
Example bullet points for a Pharmacovigilance Specialist
- Lead a case-processing team of [N] for [N] marketed products: triage, MedDRA coding, causality and expectedness, follow-up and E2B(R3) submission
- Perform medical review of serious and fatal ICSRs and write company comments in line with GVP Module VI
- Run monthly signal detection in EudraVigilance (eRMR) and Empirica; evaluated [N] signals, [N] leading to SmPC updates
- Author safety sections of PSURs/PBRERs and RMPs; supported two national inspections with zero critical findings
- Processed SAEs and SUSARs for [N] oncology and immunology trials, including reconciliation with clinical databases
- Wrote [N]+ DSURs and line listings; trained [N] new associates on Argus and MedDRA
- Prepared aggregate safety data for [N] DSMB meetings and supported unblinding requests
- Dispensed prescriptions, counselled patients on interactions and reported adverse reactions to the national authority
Replace the [brackets] with your own numbers and facts. Never claim results you didn't achieve.
Skills to include
- ICSR processing & medical review
- Signal management
- PSUR / PBRER / RMP
- GVP & inspection readiness
- Oracle Argus
- EudraVigilance
- Empirica Signal
- MedDRA
- Veeva Vault Safety
Tips for a Pharmacovigilance Specialist resume
- Put the hard requirements recruiters screen for in the top third: ICSR processing & medical review, Signal management, PSUR / PBRER / RMP.
- List current credentials with the issuing body, e.g. Licensed Pharmacist, EudraVigilance Certified User.
- Give every recent role at least one measured result — for example cases / year.
- Match the job title in your headline to the posting where it is honest to do so.
- Run the built-in resume checker and paste the job description into the keyword match before you download.
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