19 May, 2022
Job –Drug Safety Physician/Senior Drug Safety Physician/Principal Drug Safety Physician, Location – anywhere in India/or Home based.
The incredible growth at Parexel continues! Our Global Safety Services team is still growing! We’re currently looking for an experienced Drug Safety Physician to join our team in India.
Our ideal candidate should have MBBS or a MD degree with 2+ years of aggregate writing experience.
Job location : Hyderabad/Bangalore/Chandigarh/Mohali/Delhi/Mumbai/Decentralised
If interested pls share your Cv’s with Subramanyam.Turga@Parexel.com
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
• 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 advice/input for narratives written for Clinical Study Reports (CSRs)
• 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, Safety Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert
Statement, Investigator notification letters
• Function as pharmacovigilance representative/safety scientist.
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 case processing team
Periodic reports:
• 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
Literature review • Review of literature for product safety assessment and potential safety
issues
CSR Narratives:
• Performing medical review of CSR narratives according to the client’s
guidelines and SOPs
Safety Scientist:
• Contribute to Pharmacovigilance and Risk Management planning for
designated products by preparation of safety surveillance strategy and
highlighting and tracking potential issues
• Support the preparation and maintenance of Risk Management plans
• Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU
renewal, Health Hazard Assessments and other Annual Safety/addendum
reports) in accordance with regulatory requirements and standard operating
procedures
• Support the preparation and maintenance of safety sections of the Company
Core Data Sheet, local labels and Development Core Safety Information
(DSCI)
• Coordinate safety activities between PDS and internal and external partners
• Conduct/support signal detection and evaluation according to SOPs and
guidelines
• Prepare safety assessments, drug safety reports, as necessary, for potential
signals or issues (product quality)
• Perform review and summarization of literature citations including
epidemiology background research
• Provide safety content review of clinical protocols, study reports,
Investigators Brochure and other related documents to ensure alignment
with CDP
• Contribute to regulatory agency submissions (IND applications, NDAs,
MAA’s, Variations, Renewals) by reviewing safety data and preparing
relevant sections of the filing documents and submission packages
• Participate in or provide input for Drug Safety Monitoring Boards or
independent monitoring committee meetings, as applicable
Skills:
• 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:
Good knowledge of medical terminology.
Fresher/ relevant experience into pharmacovigilance/ Drug Safety field is preferred.
Education:
Graduation/Post Graduation in Medicine. (MBBS or MD)
Apply through this Link