Drug Safety Associate

Responsibilities

• Serve as second line of contact for the incoming calls to medical affairs department.
• Intake new and follow up spontaneous Adverse Events and record the discussion in relevant AE worksheet.
• Writing case narratives for serious/non-serious, study reports and quality/product complaint reports prior to sign off by medical information manager or Global Pharmacovigilance Team (GPV).
• Evaluate cases for seriousness and expectedness criteria. Enter in AE cases in safety database in timely manner for further processing by MIS and Pharmacovigilance Group.
• Maintain Adverse event and safety database log and coordinate distribution of safety data as needed.
• Maintain verification of reconciliation and email correspondence in Drug Safety shared drive.
• Distribute adverse event reports to plant QA/GPV/partner companies in accordance with Safety Data Exchange Agreements (SDEAs).
• Obtain follow-up information via mail or telephone from healthcare professionals and consumers as per the relevant SOP or as per the ongoing medical conditions.
• Monitor status of follow-up letters to ensure follow-up information is requested in the required timeframes.
• Follow up with reporter/patient/HCP at defined interval either by phone or email.
• Maintain US Adverse Event and safety database and coordinate distribution of safety data.
• Interact with data intake and entry group to ensure complete quality and output and provide guidance on follow up as needed.
• Handling Product Complaints related to Adverse Events.
• Performing reconciliation with business partners and vendors for AE reports exchanges.
• Responsible for taking appropriate decisions by applying knowledge of FDA and ICH GCP and GVP standard regulations to write overall case summary.
• Aid with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required.
• Perform Quality Review on safety database for other Drug Safety Associate’s cases.
• Aid with additional drug safety activities as required.
• Perform retrospective equality review and document findings, and contribute to metric compilation.
• Support the identification of corrections and creation of updates in safety database following medical review.
• Implement and execute QC on key fields for serious cases.
• Offer during reviews and audits of safety data and database.
• Perform Individual Case Safety Report (ICSR) processing activities within the safety database and do quality checks on the assigned ICSR.
• Support for Regulatory Inspections.
• Ability to distinguish and analyze the ratio of risk and benefits of the drug that is marketed.
• Database searches, as necessary.

Requirements

• Bachelor’s Degree in life sciences, pharmacy, nursing (RN, RPh) or combination of Health-Related Degree and clinical experience in a medical setting.
• Two years of experience in pharmaceutical drug safety/pharmacovigilance including experience in triaging of cases, coding of terms using MedDRA, data entry and narrative writing.

Work Environment

• This is an office-based position, located in our office in Pennington, NJ.
• The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.