Glenmark looking for Pharmacovigilance Scientist
Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries. Glenmark employs nearly 6000 people in over 80 countries. It has twelve manufacturing facilities in four countries and has five R&D centres.
Post : Pharmacovigilance (PV) Scientist
The Pharmacovigilance Scientist will work with other team members around the world to support and assist in the handling of safety information originating from clinical trials and marketed medicinal products. This person will assist with managing the safety tasks performed by a Pharmacovigilance provider and will focus on efficient, accurate, and timely reporting of adverse events, aggregate safety reports (i.e. PADER) and will support PV managers with other Pharmacovigilance activities as required by the business. This person will also play an important role representing the Pharmacovigilance group during daily interactions with clinical teams, US regulatory affairs team, data management, biostatistics, and other groups within Global Pharmacovigilance such as the Safety Evaluation and Risk Management (SERM) team.
• Serve as the primary role for triage and quality control (QC) of individual case safety reports (ICSR) ensuring that adverse event reports are reviewed and processed in a timely manner, and in accordance with the appropriate company SOPs (standard operating procedures), study protocols and regulatory guidelines (mainly SUSAR reports)
• Work with the clinical project teams to ensure consistency in the assessment, recording, and coding of clinical safety events (e.g. SAEs)
• Prepare and review queries to obtain critical or missing serious adverse events (SAEs) information for appropriate medical assessment and case closure
• Serve as Adjudication Coordinator and ensure that endpoint dossiers are prepared and completed in timely manner for submission to Adjudication Committee if needed.
• Participate in SAE reconciliation data between clinical and safety databases.
• Assist with data-lock reconciliations and ensure all cases are complete and all outstanding queries are resolved and closed.
• Demonstrates knowledge of safety concepts, per ICH and FDA guidelines per device safety reporting requirements
• Applies Good Clinical Practices in documentation of phone, electronic, and/or fax correspondence regarding initial case reports and follow-up per CRF’s SOPs
• Support the development of assessment tools, training programs, policies and interpretation of requirements
• Remains informed of all appropriate current health authority regulations and guidance
• Perform other duties as assigned by supervisor
• Nurse (RN/BSN), Life Science BS degree with at least 5 years of experience in Pharmacovigilance
• Pharmacists (RPh/PharmD) with at least 3 years of experience in Pharmacovigilance
• Pharmacovigilance experience with a global drug safety database is required
• Knowledge of MedDRA and WHO- Drug dictionaries for coding consistency is a must
• 2 to 3 years of Clinical Trial Case processing including SAE reconciliation is highly preferable.
• Thorough understanding of the clinical research process with broad knowledge of GCP & ICH reporting guidelines.
• Strong familiarity of US FDA and international regulations governing the collection, processing, and reporting of adverse event information.
• Excellent attention to details and effective communication and organizational skills
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