Company: Parexel
Location: India-Mohali-Remote
Time Type: Full time
Job Requisition ID: R0000023668
Posted On: Posted Today
Job Overview
At Parexel, we share a common goal: to improve global health. Our clinical development solutions, from clinical trials to regulatory consulting and market access, are driven by our deep conviction in our work. Each team member at Parexel contributes to developing therapies that benefit patients, working with empathy and commitment to make a difference.
Job Purpose
Provide medical review, analysis, and guidance during the case handling and reporting cycle of Adverse Event (AE) and Adverse Reaction reports for investigational and marketed products.
Offer medical guidance and input to Drug Safety Associates (DSAs) and specialists on medical aspects of drug safety.
Function as a pharmacovigilance representative/safety scientist.
General Responsibilities
Maintain a good working knowledge of the adverse event profile of assigned products, labeling documents, data handling conventions, client guidelines, and international drug safety regulations.
Stay aware of global regulatory requirements and reporting obligations, organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
Keep an excellent knowledge of the safety profile of assigned products.
Communicate and discuss issues related to the review process with the Project Manager.
Interact with internal and external contacts to resolve issues.
Maintain a good working knowledge of relevant regulatory guidelines.
Attend and present at client/cross-functional meetings with other stakeholders.
Train and mentor new team members, as required.
Work as a Subject Matter Expert (SME).
Assist the Manager with inspection readiness activities and audits.
Provide inputs for process improvements.
Work closely with the Manager for process coordination and to ensure meeting all KPIs for the process.
Case Report Medical Review (as applicable)
Perform medical review of cases according to client Standard Operating Procedures (SOPs) and liaise with the client, as required.
Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assess company causality.
Assess the seriousness and expectedness of reported events.
Provide medical advice to DSPs and the case processing team.
Skills
Excellent interpersonal, verbal, and written communication skills.
Computer proficiency and ability to work with web-based applications and familiarity with the Windows operating system.
Client-focused approach to work.
Flexible attitude towards work assignments and new learnings.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Ability to assess the clinical relevance of medical data and interpret its clinical meaning.
Willingness to work in a matrix environment and value the importance of teamwork.
Strong knowledge of international drug regulations, including GCP and GVP.
Knowledge and Experience
2 years of relevant Individual Case Safety Report (ICSR) experience in pharmacovigilance/drug safety is desirable.
Education
MBBS/Post-Graduation in Medicine.
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Zagreb |Republic of Egypt :
Cairo |United Kingdom :
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Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote - Europe | Remote | Remote, USA | Switzerland |Makkah :
Riyadh | Khulais | Najran | Rabigh | Jeddah |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |