Drug Safety Associate

Zydus Pharmaceuticals USA Inc•Hopewell Township, NJ

About The Position

SUMMARY: Responsible for executing US Adverse Event and Pharmacovigilance activities as required by FDA Regulations. Provide support and oversight in drug safety related activities including Product Quality Complaints and Medical Information activities. Zydus Pharmaceuticals (USA) Inc. is a globally integrated generic pharmaceutical company with a focus on providing high service, quality, and affordable products. Our US leadership, which has over 60 years of US generic market experience, understands the customer’s business which allows Zydus the ability to provide unique models to help drive their customer’s success. Our parent company, Zydus Cadila, has a large presence in global markets, including relationships with many top tier international pharmaceutical companies. Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India.

Requirements

Hands on experience with safety database, i.e. ARGUS, ARIS-G, PVNet or other
Extensive working knowledge of FDA regulations, FDA guidance and ICH guidance; some familiarity exposure to EMEA regulations
In-depth understanding of the ICSR assessment and reporting process
Proficient in outlook, MS Word, PowerPoint and Excel.
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.

Responsibilities

Serve as second line of contact for the incoming calls to medical affairs department.
Train team members in processing and assessing adverse event (AE) cases.
Ensure submission of AE cases through communication with the global PV team.
Ensure compliance with timelines set forth in various SDEAs and SOPs
Align company procedures with current pharmacovigilance practices.
Provide updates to senior management on AE case processing.
Assist with coding verbatim AEs, medical history, laboratory data, and medicinal products using MedDRA and WHO-DD coding.
Review, assess, and analyze the appropriateness of spontaneous AE categorization
Evaluate cases for seriousness and expectedness criteria.
Review and evaluate medical information inquiries to determine legitimacy and identify potential AEs or product complaints (PCs).
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)
Monitor status of follow-up letters to ensure follow-up information is requested in the required timeframes
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.
Ensure proper processing of Adverse Events (AEs) related to product complaints (PCs).
Perform 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.
Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required.
Perform quality reviews of AE cases entered by MIS and DSA teams for PV compliance.
Perform medical review of AE cases before circulation to the GPV team for submission.
Assist with additional drug safety activities as required.
Perform retrospective quality 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.
Conduct monthly reconciliation of AE cases with business partners.
Review Health Hazard Evaluation (HHE) documents
Review Safety Data Exchange Agreements (SDEAs) for accuracy.
Ensure department training and SOPs are current and compliant.
Offer during reviews and audits of safety data and database.
Support for Regulatory Inspections, internal and external audits.
Ability to distinguish and analyze the ratio of risk and benefits of the drug that is marketed.
Participate in advisory board meetings related to various REMS programs and pregnancy registries.
Database searches, as necessary.
Perform other duties as assigned.