Parexel invites talented professionals to join as Senior Drug Safety Physicians for remote positions in Chandigarh and Mohali. Dive into this article to explore the qualifications, responsibilities, and benefits of working from home with Parexel.
About Parexel: Discover Parexel's mission to improve global health through clinical trials, regulatory consulting, and market access solutions. Learn how every team member contributes to patient care and therapy development.
Job Details:
- Position: Senior Drug Safety Physician
- Location: Remote (India-Chandigarh, India-Mohali)
- Time Type: Full-time
- Job Requisition ID: R0000022700
Qualifications: Minimum 1 year of experience in safety scientific writing/PSUR/PBRER/Aggregate report/Signal detection/analysis/evaluation. Candidates should have expertise in providing medical guidance, safety input, and review of safety reports as per regulatory guidelines.
Responsibilities:
- Performing medical review of literature references in accordance with client procedures and
- Standard Operating Procedures/regulatory guidelines for the purpose of product safety assessment
Signal detection/analysis/evaluation and ongoing safety surveillance activities
- Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical
aspects of drug safety
- Provide medical, safety input and review of all required safety reports, such as- but not limited to -
Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Assessment Reports (PBRERs)/
Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans (RMPs), Benefit
Risk Assessment, Signal Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert
Statement, Investigator notification letter
- Review and authoring of aggregate reports for medical context and consistency in accordance with client requirements and SOPs
- Providing medical advice to case processors for authoring of sections
- Training and mentoring new team member, as required
- Working as Subject Matter Experts (SMEs)
- Assisting the Manager DSP for inspection readiness activities and audits
- Provides inputs for process improvisations
Benefits of Working with Parexel: Explore the benefits of working remotely with Parexel, including flexible hours, professional growth opportunities, training, and a supportive work environment.
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Parexel Hiring Senior Drug Safety Physician[/caption]
https://pharmastuff.org.in/job/parexel-hiring-senior-drug-safety-physician
