When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Job Purpose:
Provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports received for investigational and marketed products
Provide medical guidance and input to Drug Safety Associates (DSAs) and specialists in medical aspects of drug safety
Function as pharmacovigilance representative/safety scientist
General
Maintaining a good working knowledge of the Adverse event profile of
assigned products, labeling documents, data handling conventions,
client’s guidelines and procedures, and international drug safety
regulations
Maintaining an awareness of global regulatory requirements and
reporting obligations and organizing workload to ensure compliance with
internal and regulatory timelines for adverse event reporting
Maintaining excellent knowledge of the safety profile of assigned
products
Communicating and discussing issues related to review process with
Project Manager
Interacting with internal and external contacts for resolving issues
Maintaining a good working knowledge of relevant regulatory guidelines
Attend and present client/cross functional meetings along with other
stakeholders
Training and mentoring new team member, as required
Working as Subject Matter Experts (SMEs)
Assisting the Manager for inspection readiness activities and audits
Provides inputs for process improvisations
Works closely with Manger for process co-ordination and to ensure
meeting all KPIs for the process.
Case report Medical review (as applicable)
Performing medical review of cases according to client Standard
Operating Procedures (SOPs) and liaising with the client, as required
Writing Pharmacovigilance/Marketing Authorization Holder (MAH)
comment and assessing company causality
Assessing seriousness and expectedness of reported events
Providing medical advice to DSPs and case processing team
Skills:
Excellent interpersonal, verbal and written communication skills
Computer proficiency, an ability to work with web-based applications and familiarity with the
Windows operating system
Client focused approach to work
A flexible attitude with respect to 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 to interpret its clinical meaning is
essential
Willingness to work in a matrix environment and to value the importance of teamwork
Strong knowledge of international drug regulation including GCP, GVP
Knowledge and Experience:
2 Years relevant ICSR experience in Pharmacovigilance/ drug safety is desirable.
Education:
India
