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Drug Safety Specialist

2-3 years
Not Disclosed
10 June 18, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Drug Safety Specialist – Pharmacovigilance (SDEA Specialist)

Location: Remote

Job Summary:

Parexel is hiring a Drug Safety Specialist – Pharmacovigilance to manage global Safety Data Exchange Agreements (SDEA) and ensure compliance with international pharmacovigilance regulations. This remote position involves coordinating safety information exchange, managing safety databases, and supporting global pharmacovigilance processes for clinical and marketed products, including vaccines and medical devices. An excellent opportunity to contribute to worldwide drug safety and PV operations.


Key Responsibilities:

  • Manage Global and Local SDEAs, PV clauses, and Vigilance Agreements for investigational and marketed products

  • Review and assess PV obligations related to ICSR processing, PSURs/PBRERs, RMPs, signal detection, and literature screening

  • Update and configure safety databases as per PV requirements

  • Generate Business Partner reports and maintain the Contract Management Database

  • Track agreements, expirations, and amendments; ensure proper documentation

  • Provide SDEA process guidance to stakeholders and conduct training sessions

  • Perform quality checks on data entries and monitor KPIs and metrics

  • Support periodic aggregate report teams in PSURs/DSURs preparation

  • Stay updated with global PV regulations and best practices

  • Assist during audits and inspections related to safety data processes


Required Skills & Qualifications:

  • Bachelor’s degree in Life Sciences, Pharmacy, or related field (Advanced degree preferred)

  • 2-3 years of experience in pharmacovigilance or clinical research

  • Experience in SDEA/PVA management and safety database handling

  • Strong knowledge of ICH, EMA, FDA PV guidelines

  • Understanding of ICSR processing, aggregate reporting, signal detection, and RMPs

  • Familiarity with master service agreements and PV terminologies

  • Proficient in medical terminology and adverse event coding

  • IT proficiency with MS Office Suite and web-based applications


Desired Skills:

  • Analytical skills for safety data evaluation

  • Independent decision-making abilities

  • Strong teamwork and client-focused approach

  • Ability to prioritize multiple tasks with attention to detail

  • Exposure to automation or AI tools in pharmacovigilance is a plus


Perks & Benefits:

  • Remote work flexibility

  • Exposure to global pharmacovigilance operations

  • Training and career development programs

  • Participation in audits and regulatory inspections

  • Opportunity to work with global biopharma leaders


Company Description:

Parexel is a globally recognized Clinical Research Organization (CRO) dedicated to improving patient health through clinical trials, drug development, and pharmacovigilance services. With a focus on innovation and regulatory compliance, Parexel empowers healthcare organizations worldwide.


Work Mode:

Remote


Call to Action:

Ready to advance your pharmacovigilance career? Apply now for the Drug Safety Specialist role at Parexel and play a vital part in ensuring global drug safety compliance.