SeniorFull TimeEN
Pharmacovigilance Lead Signal Detection
Summary
The Pharmacovigilance Lead Signal Detection is a senior expert responsible for leading and executing signal detection and evaluation activities across assigned client portfolios. The role combines scientific and epidemiological expertise with operational oversight of signal management workflows, ensuring that emerging safety signals are identified, assessed, prioritized, and communicated in compliance with applicable regulatory requirements (EMA GVP Module IX, ICH E2E, FDA) and client-specific procedures. The Signal Management Lead serves as the subject matter expert for signal-related activities and collaborates closely with medical reviewers, project leads, and client stakeholders.
Essential Functions
Education:
Advanced degree in pharmacy (PharmD preferred), medicine, life sciences, or epidemiology.
A postgraduate qualification in pharmacoepidemiology or drug safety is an advantage.
Experience:
Minimum 4 years of PV experience, with at least 2 years focused on signal detection or pharmacoepidemiology at a PV vendor, CRO, or pharmaceutical company.
Hands-on experience with signal detection methods and regulatory safety databases (FAERS, EudraVigilance, VigiBase) required.
Computer Skills:
Safety databases (like Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy), signal detection tools, literature databases (Embase,PubMed), Microsoft Office Suite. Familiarity with statistical tools is an advantage.
Work Environment
Remote: Romania / Poland or Portugal
The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.
To apply for this role:
Step 1: Proceed to follow the form instructions
Step 2: Our HR team will review your application with feedback
Step 3: If successful, HR will arrange your Introductory call
Step 4: A potential online language assessment
Step 5: 1st formal interview
Step 6: 2nd formal interview
Step 7: Offer
NB* To be fully informed, the Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible.
Disclaimer
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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.
Recruitment Agency Notice:
Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes.
Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy.
Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.
