PAREXEL Hiring Drug Safety Physician

PAREXEL welcomes you to join our dedicated team as a Drug Safety Physician in Hyderabad. As a global pharmaceutical and healthcare organization, we are at the forefront of advancing and improving patients’ lives. We are looking for individuals who share our vision and are driven to make a meaningful impact in the field of drug safety.

Vacancies List:

• Company Name: PAREXEL
• Company Address: Hyderabad
• Position Title: Drug Safety Physician
• Role: Drug Safety Physician
• Department: Drug Safety
• Industry Type: Pharmaceutical and Healthcare
• Employment Type: Full-Time
• Role Category: Healthcare

Job Description:

As a Drug Safety Physician at PAREXEL, you will be responsible for a range of key activities:

Supporting Activities General:

• Maintain a strong understanding of adverse event profiles, labeling documents, data handling conventions, client guidelines, and international drug safety regulations.
• Ensure compliance with internal and regulatory timelines for adverse event reporting.
• Communicate and collaborate with internal and external stakeholders.
• Maintain knowledge of relevant regulatory guidelines.
• Participate in client meetings and provide subject matter expertise.
• Assist with inspection readiness and audits.
• Provide input for process improvements and ensure KPIs are met.

Case Report Medical Review (as applicable):

• Conduct medical review of cases according to SOPs.
• Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments.
• Assess seriousness and expectedness of reported events.
• Provide medical advice to the team.

Periodic Reports (as applicable):

• Review and author aggregate reports.
• Provide medical advice to case processors.
• Literature Review (as applicable).
• Review literature for product safety assessment and potential safety issues.

CSR Narratives (as applicable):

• Perform medical review of CSR narratives according to guidelines.

Safety Scientist (as applicable):

• Contribute to safety planning and tracking.
• Prepare and review periodic safety reports.
• Support the preparation and maintenance of safety sections in documents.
• Coordinate safety activities and conduct signal detection.

Signal Detection and Management (as applicable):

• Perform signal detection review and analysis.
• Responsible for end-to-end signal management.
• Conduct signal detection and evaluation activities.

Key Skills:

• Excellent interpersonal and communication skills.
• Computer proficiency and web-based applications.
• Client-focused approach.
• Flexibility in handling diverse tasks.
• Ability to assess the clinical relevance of medical data.
• Teamwork and knowledge of international drug regulations.

Knowledge and Experience:

• Relevant experience in Pharmacovigilance/drug safety is desirable.
• Experience in relevant fields is preferred.

Education:

• Graduation/Post Graduation in Medicine (MBBS/MD).

If you are an MBBS/MD with a passion for drug safety and meet the qualifications for this position, please send your resume to Subramanyam.Turga@Parexel.com.