Drug Safety Specialist

07 Apr 2021
07 May 2021
Medical Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

The Drug Safety Specialist will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Responsible for processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable. Responsible for ICSR compliance and quality related processes also.

  • 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.
  • Preparation for, participation in, and follow up on audits and inspections
  • Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
  • Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches etc.
  • Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
  • Preform a check on overall medical cohesiveness and consistency of the document
  • Compares and analyses data provided by the affiliate with the data available on client application
  • Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool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 and performs Data entry into safety database
  • 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
  • Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
  • Case reconciliation- coordinating activities with Data Management personnel
  • Maintain local drug safety reporting requirements
  • Perform registration with relevant authorities for electronic reporting on behalf of sponsor
  • Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
  • Submission of safety reports to investigators via ISIS (International Safety Information System)
  • Unblinding of SUSARs, as required
  • Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client
  • Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures
  • Creation of reports for publishing in order to dispatch the dossier to affiliates or agency (EMA) and generation of marketing authorization status reports from the database for co-ordination of PV activities
  • Validation of the data content with the latest version of SmPC and performing the xEVMPD submissions via EMA Gateway for client's products and tracking the status of submissions and acknowledgement date
  • Qualifications

  • Sound knowledge of drug safety and the drug development process
  • Knowledge of and ability to interpret and apply global safety regulations
  • Experience in data analysis and evaluation of safety data
  • Good presentation skills
  • Analytical and problem-solving skills
  • Clear understanding of the regulatory submission process
  • Proficient in database/literature searches
  • Excellent interpersonal skills
  • Excellent verbal / written communication skills
  • Excellent organizational and prioritization skills
  • Ability to work collaboratively and effectively in a team environment
  • Ability to evaluate data and draw conclusions independently
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

  • Knowledge and Experience:
  • Related experience in drug safety/ pharmacovigilance is desirable
  • Good knowledge of medical terminology

  • Education:
  • Degree in life Sciences, Health or Biomedical 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
  • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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