Parexel hiring MBBS/MD candidates with two years of expertise in the medical review of ICSRs for the role of Drug Safety Physician or Senior Drug Safety Physician. Please go through the below mentioned details and follow the given link for JD or more information.
Location - Chandigarh/Mohali/Hyderabad/Remote
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: Chandigarh/Mohali/Hyderabad/Remote
- Time Type: Full-time
Qualifications: MBBS/Post Graduation in Medicine.
Responsibilities:
- Performing medical review of literature references in accordance with client procedures and
- Standard Operating Procedures/regulatory guidelines for the purpose of product safety assessmentSignal 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
Skills Required to Apply Drug Safety Physician
- 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.
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
