Are you passionate about improving global health and ensuring drug safety? Parexel, a leading clinical research organization, is hiring a Drug Safety Physician in Mohali, India. If you have a medical background and a keen interest in pharmacovigilance, this is your chance to make a difference. Read on to learn more about this exciting opportunity!
About Parexel
At Parexel, we are driven by a shared mission – to improve the world’s health. From clinical trials to regulatory consulting and market access, our work is rooted in a deep commitment to patient safety and well-being. Every role at Parexel contributes to the development of therapies that benefit patients worldwide.
We take our work personally, approach it with empathy, and are dedicated to making a meaningful impact. If our values align with yours, there’s no limit to what we can achieve together.
Job Purpose
As a Drug Safety Physician, you will play a critical role in ensuring the safety of investigational and marketed products. Your responsibilities will include:
- Medical Review and Analysis: Providing medical guidance during the handling and reporting of Adverse Events (AEs) and Adverse Reactions (ARs).
- Signal Detection and Surveillance: Conducting ongoing safety surveillance and evaluating potential safety signals.
- Regulatory Compliance: Ensuring adherence to global drug safety regulations and internal timelines.
- Collaboration: Working closely with Drug Safety Associates (DSAs), specialists, and cross-functional teams to resolve safety-related issues.
- Documentation: Reviewing and providing medical input for Clinical Study Reports (CSRs), Benefit Risk Assessments, Safety Evaluation Reports (SERs), and more.
Key Responsibilities
1. Case Report Medical Review
- Perform medical reviews of adverse event cases in line with client SOPs.
- Assess seriousness, expectedness, and causality of reported events.
- Provide medical advice to the case processing team.
2. Literature Review
- Review scientific literature for product safety assessments.
- Identify and evaluate potential safety issues.
3. Regulatory Knowledge
- Maintain up-to-date knowledge of global regulatory requirements, including GCP (Good Clinical Practice) and GVP (Good Pharmacovigilance Practices).
- Ensure compliance with regulatory timelines for adverse event reporting.
4. Client and Stakeholder Interaction
- Attend and present at client and cross-functional meetings.
- Collaborate with internal and external stakeholders to resolve safety-related issues.
Skills and Qualifications
To excel in this role, you will need:
Essential Skills
- Medical Expertise: Strong knowledge of medical terminology and the ability to interpret clinical data.
- Communication: Excellent interpersonal, verbal, and written communication skills.
- Technical Proficiency: Familiarity with web-based applications and the Windows operating system.
- Attention to Detail: Ability to manage multiple tasks and prioritize workload effectively.
- Teamwork: Willingness to work in a matrix environment and collaborate with diverse teams.
Education and Experience
- Education: Graduation or Post-Graduation in Medicine (MBBS/MD).
- Experience: Freshers or candidates with relevant experience in pharmacovigilance or drug safety are preferred.
Why Join Parexel?
- Impactful Work: Contribute to the development of therapies that improve patient lives.
- Global Exposure: Work with international regulatory standards and global teams.
- Professional Growth: Opportunities to learn and grow in a dynamic, supportive environment.
- Innovative Culture: Be part of a company that values innovation, empathy, and collaboration.
