Drug Safety Physician

5 months ago

Mohali, India Parexel Full time

Mohali, India

**Job ID** R0000015852

**Category** Medical Sciences

**ABOUT THIS ROLE**:
**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.

Provide medical advice/input for narratives written for Clinical Study Reports (CSRs)

**General**:
Maintaining a good working knowledge of the Adverse event profile of assigned products, labeling documents, data handling conventions, clients 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

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

Literature review (as applicable)

Review of literature for product safety assessment and potential safety issues

**Skills**:
Excellent interpersonal, verbal and written communication skills

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**:
Experience in Clinical/Academic is desirable.

**Education**:
MBBS/Post Graduation in Medicine.

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