Drug Safety Case Intake Specialisty PVexp LP

Position Drug Safety Case Intake Specialist2y PVexp 5 openingsLP7780 Location Basking Ridge Job Description Client Large Pharmaceutical Company Contract Position 6 months with potential extension if needs allow. Title Patient Safety Specialist (Real position Drug Safety Case Intake Specialist) Location Plainsboro, NJ - ONSITE (after a while able to work from home a few days) Type ONSITE (worker can work from home few days/weeks after discussion with the reporting manager, as needed) Type of worker W2 is required. No subcontracting. Required Bachelor's degree, 2 years experience. Advantage, but not required Speaking Spanish. Job Posting Number 7780 Type of Worker Needed 2 years relevant experience is required. An entry-to-mid-level pharmacovigilance / drug safety specialist focused on adverse event case processing, safety intake, MedDRA coding, and strong written case documentation. Soft skills that are helpful Calm, detail-oriented, highly collaborative professional with strong written communication, flexibility, dependable, process-driven style well suited for accurate pharmacovigilance case work in a fast-paced team environment. Target Start Date ASAP Duration 6 months Schedule Mon-Fri 830a-500p (up to 40 hours/week) Must Haves

• A bachelor’s degree is required (preferably in a medical or science-related discipline); relevant experience may be substituted for the degree when appropriate (e.g., a Registered Nurse with clinical experience).
• A minimum of 2 years of progressively responsible and relevant pharmacovigilance experience, including MedDRA coding and adverse event identification, is required.
• Exceptional knowledge of medical and pharmacovigilance terminology is required. Purpose Responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, for the COMPANY US marketed products (drugs and devices) and investigational products. Also responsible for ensuring compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety records. Relationships Reports to Patient Safety Management. Daily internal interactions with personnel from Patient Safety, Medical Information, Field Sales, Customer Complaints Center, Suppliers and Patient Centric Customer Care. Manager said to be comfortable working with a team of 10. Daily external interactions with patients, caregivers, and health‑care professionals. Essential Functions
• Processing of adverse events and associated technical complaints and analysis results related to marketed NNI products into the local intake, complaint, and global safety databases, including duplicate searches, product coding, MedDRA coding, narrative generation, labeling assessment according to the current approved product label, receiving inbound and making outbound calls for adverse events and technical complaints including handling of refund or replacement requests.
• Perform data entry and review of adverse events and associated technical complaints and provide ongoing feedback regarding case quality to other case handlers to support their continued development and ensure excellent case quality.
• Handle incoming and outgoing follow‑up correspondence, collect and document information received during outbound follow‑up calls, perform triage, case classification and case assignment, handle escalated calls for adverse events and technical complaints.
• Assist with training of new hires; mentor new hires; perform reconciliations; assist with workload coordination/distribution; perform call monitoring; support the identification of trends and implementation of corrective actions for issues identified during case review; coordinate configuration requests for the safety and complaint databases; serve as Subject Matter Expert during audits/inspections for case handling; build customer loyalty by providing high‑quality customer service; provide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scripts; identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to… Apply tot his job Apply To this Job

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