Pharmacovigilance Specialist
EyeBio
Job Description
Job Description:
Responsible for PV activities which may include but is not limited to:
local PV processes and activities in collaboration with internal functional areas and external parties, PV Intake activities (including reconciliation and follow-up), Individual case safety report (ICSR) and aggregate submissions, compliance monitoring, management and negotiation of local PV agreements, local due diligence activities, supporting audits and inspections and related readiness and corrective action activities, authoring local SOPs, conducting local training, local literature screening and assessment, ensuring the implementation of risk minimization measures and additional risk minimization measures, support local implementation of applicable business continuity plans, and archiving/ filings and is able to perform these tasks with minimal supervision.
Education:
Health, life science, or medical science degree or equivalent by education/experience
Qualification:
Have a minimum 1 year of industry experience in pharmacovigilance is preferred
General knowledge of AE reporting requirements and relevant PV regulations is preferred
Must be fluent in English (written and spoken) while proficient in local language
Ability to work in partnership with others (internally and externally) to accomplish quality goals
Ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.
Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business.
Required Skills:
Adaptability, Adaptability, Adverse Event Report, Business Continuity, Business Process Improvements, Clinical Trial Management, Complaint Management, Compliance Investigations, Compliance Reviews, Corrective Action Management, Data Analysis, Data Management, Detail-Oriented, Drug Safety Surveillance, Employee Training, Financial Process Improvement, Immunology, IS Audit, Life Science, Management Process, Medical Care, Pharmacovigilance, Regulatory Communications, Regulatory Compliance, Risk Management {+ 2 more}Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Temporary (Fixed Term)Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
04/22/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.