- The Clinical Research & Pharmacovigilance will administer adverse event management in compliance with applicable safety, global regulatory and internal requirements through the collection, evaluation, collation, and review reported clinical trial serious adverse event reports and non-serious adverse events.
- The candidate will also support Clinical Development activities from program concept and development to IND and NDA, preparing, maintaining, and updating documents and reports for internal use and submission to regulatory authorities.
- Work with Clinical Operations and CMO to manage and oversee clinical trial subject safety.
- Implement procedures and processes for pharmacovigilance activities.
- Monitor compliance with internal PV procedures.
- Facilitate the pharmacovigilance interface between the Medical Monitor (contracted or CRO) and CMO, Clinical Sites, Vendors (CROs), and internal staff.
- Review or prepare subject safety narratives.
- Create/Manage Safety Documentation for historical and current safety cases.
- Reviews MedDRA/WHO Drug Coding as requested.
- Support Regulatory Affairs reporting of safety data and IND annual reports.
- Assists in the preparation of all documents for adjudication meetings, present subject cases at meetings, interacts with the team members as needed post meeting, and generates meeting minutes.
- Conduct pre-work and background information on development concepts.
- Review and maintain scientific data contributing to the clinical development programs. Including literature searches, management/maintenance and update of references and scientific literature associated with clinical development programs and IND.
- Prepare and review clinical study reports.
- Review scientific publications and posters.
- Contribute to or lead as assigned the preparation of clinical program documents including:
- Clinical development plans;
- Investigator brochure (IB) and updates;
- IND annual report or Drug Safety Update Reports (DSUR);
- IND updates as necessary;
- Inquiries from health professionals and regulatory authorities regarding reported adverse experiences;
- FDA or Competent Authority briefing books and submissions, and
- NDA planning and preparation.
- Able to work across multiple studies at various development phases in several therapeutic areas
- Other activities as assigned.
- Pharm D
- Minimum of 3 years clinical development experience in a pharmaceutical/biotechnology/device company (pharmaceutical preferred).
- Experience preferred with pediatric or orphan indications.
- Demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines.
- Working knowledge of the IND/NDA process acquired through direct industry experience.
- Knowledge of medical, scientific and clinical research techniques.
- Knowledge of basic statistics and pharmacokinetics a plus.
- Strong experience in medical/scientific writing skills.
- Proactive issue identification, evaluation and resolution versatility, flexibility, and superior communication skills are essential.
- Able to work with a multi-disciplinary team of professionals.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Flexible Spending Account
- Life and AD&D Insurance
- Relocation Assistance
Randstad Pharma - 20 months ago
Randstad US is a wholly owned subsidiary of Randstad Holding nv, an $18.8 billion global provider of HR services and the second largest...