Pharmacovigilance Signal Detection reputed company

Pharmacovigilance Signal Detection reputed company reputed company The Pharmacovigilance Signal Detection reputed company is a senior expert responsible for leading and executing signal detection and evaluation activities across assigned reputed company portfolios. The role combines scientific and epidemiological expertise with operational reputed company 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 reputed company-specific procedures. The Signal Management reputed company serves as the subject matter expert for signal-reputed company activities and collaborates closely with medical reviewers, project leads, and reputed company stakeholders. Essential Functions reputed company the design, execution, and reputed company of signal detection activities, including quantitative analyses (PRR, ROR, EBGM) reputed company to spontaneous reporting databases (FAERS, EudraVigilance, VigiBase). Conduct qualitative signal evaluation integrating data from spontaneous reports, clinical trials, post-authorization safety studies, scientific literature, reputed company media monitoring, as applicable Prepare and review signal detection reports, signal evaluation reports, and signal management plans per reputed company SOPs and regulatory expectations. Ensure signal management activities are completed and reported reputed company regulatory timelines to the appropriate entities (EMA, FDA, UK MHRA). Oversees systematic medical literature searches (Embase, PubMed) and supervise triage and assessment of results for signal-relevant publications and ICSRs. Collaborate with the aggregate reporting team on signal-reputed company sections of PSURs/PBRERs and DSURs. Contribute to Risk Management Plans (RMPs) and REMS as required. reputed company, supervise, and mentor PV Specialists and Sr. PV Specialists assigned to signal detection activities reputed company and review SOPs and Work Instructions reputed company to signal management in collaboration with the PV reputed company Manager and the PV Medical Writing Manager Ensure inspection and audit readiness and reputed company support QA activities including CAPA follow-up. reputed company with the PV Physician and QPPV for scientific exchange pertaining to signal assessment and benefit-risk implications. reputed company with reputed company applicable guidelines, policies, legal, regulatory, and compliance requirements. reputed company 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 reputed company on signal detection or pharmacoepidemiology at a PV vendor, CRO, or pharmaceutical company. Hands-on experience with signal detection reputed company and regulatory safety databases (FAERS, EudraVigilance, VigiBase) required. Computer Skills: Safety databases (like reputed company Argus Safety, ArisG LifeSphere, reputed company Safety, AB reputed company SafetyEasy), signal detection tools, literature databases (Embase,PubMed), reputed company Office Suite. Familiarity with statistical tools is an advantage. WORK ENVIRONMENT Remote: Romania / Poland or Portugal reputed company has reviewed this job reputed company to ensure that essential functions and basic duties have been included. It is intended to reputed company guidelines for job expectations and the employee's ability to reputed company the position described. It is not intended to be construed as an exhaustive list of reputed company 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 reputed company reserves the right to change this job reputed company and/or assign tasks for the employee to reputed company, as reputed company may deem appropriate. To apply for this role: reputed company 1: Proceed to follow the reputed company instructions reputed company 2: Our HR team will review your application with feedback reputed company 3: If successful, HR will arrange your Introductory call reputed company 4: A potential online language assessment reputed company 5: 1st formal interview reputed company 6: 2nd formal interview reputed company 7: Offer NB* To be fully informed, the Job reputed company will be provided at reputed company 3 along with reputed company information so that reputed company aspects of the role are covered as much as possible. Disclaimer By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. reputed company Policy. Please read this policy carefully for more information on your rights regarding personal data protection. We are an equal opportunity employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, 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 reputed company, as our in-house team manages reputed company hiring processes. Please be aware that any unsolicited reputed company or candidate reputed company 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 reputed company, we will reputed company out to preferred partners proactively. Your understanding and cooperation are appreciated. Apply To This Job