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Senior Drug Safety Physician

P

Location
India
Parexel

Job Description

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:

MBBS/Post Graduation in Medicine.

Advice from our career coach

A successful applicant should know that working at Parexel involves a strong commitment to improving global health through clinical development solutions. To stand out as an applicant for the Medical Reviewer role, consider the following tips:

  • Emphasize your ability to provide medical review, analysis, and guidance during the case handling and reporting cycle of Adverse Event and Adverse Reaction reports for investigational and marketed products.
  • Showcase your expertise in maintaining a good working knowledge of adverse event profiles, international drug safety regulations, and global regulatory requirements.
  • Highlight your communication skills by demonstrating your ability to interact with internal and external contacts, present at client meetings, and mentor team members.
  • Illustrate your proficiency in medical data assessment, interpretation, and a client-focused approach to work.
  • Consider obtaining relevant ICSR experience in Pharmacovigilance/drug safety and the required MBBS/Post Graduation in Medicine.

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