Drug Safety Associate require at PAREXEL | B.Pharm

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PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Drug Safety Associate I

Job Description
• Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
• Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
• Assist in development of project specific safety procedures, workflows and templates
• Attend internal, drug safety and project specific training sessions
• Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
• Preparation for, participation in, and follow up on audits and inspections
• Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
• Delegate work as appropriate to Drug Safety Assistants
• Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
• Identifies areas of concern and raising the issues with the manager
• Archiving the source documents and relevant emails as required
• Responds to clients/customers in a timely manner

Case processing
• Monitoring of incoming reports from various sources viz mailboxes, EudraVigilance, literature searches etc.
• Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
• Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
• Responsible for sending translation requests, if any
• Compares and analyses data provided by the affiliate with the data available on client application
• Prepares ADR form/coversheet as required
• Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
• Creates the case on the safety database
• Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
• Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
• Ensures MedDRA coding in accordance with “MedDRA Term selection: Points to Consider”
• Request follow-up and perform query management, as applicable
• Prepares medically cohesive case narratives based upon the reported information
• Routes the case to the next workflow state as applicable in the safety database
• Performs quality checks/validation checks

Candidate Profile
• Degree in life Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.).
• A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage
• 0-2 years of experience.
• Good knowledge of medical terminology.
• Related experience gained in a healthcare environment is an advantage.
• Analytical and problem-solving skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Excellent organizational and prioritization skills
• Ability to work collaboratively and effectively in a team environment
• Client focused approach to work
• Ability to evaluate data and draw conclusions independently
• Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

Additional Information
Experience : 0-2 years
Qualification : B.Pharm, B.Sc
Location : Chandigarh
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Drug Safety
End Date : 20th July, 2020


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