Drug Safety Specialist
SUMMARY: Under direct supervision, this individual performs detailed and routine work effectively, using limited judgment and discretion.ESSENTIAL DUTIES AND
RESPONSIBILITIES (include, but are not limited to):
Provide oversight of outsourced safety-related functions.
Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements.
Prepare for expedited reporting of SAEs, including preparation of analysis of similar events.
Support the preparation of periodic safety reports in accordance with regulatory requirements and standard operating procedure.
Support signal detection and evaluation activities in accordance with SOPs and guidelines.
Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents.
Participate in for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable.
Assists in resolving database discrepancies and end of study adverse event reconciliation.
Prepares responses to safety-related queries.
Interface with Medical Writing, Data Management, Regulatory, and Clinical Project team.
Develops and maintains drug safety SOPs.
Strong knowledge of US and EU pharmacovigilance regulatory requirements.
Strong knowledge of current pharmacovigilance practices.
Experience and knowledge of drug safety databases; experience with ARISg is a plus.
Ability to evaluate, interpret and synthesize scientific data
Team player with ability to function in a multi-disciplinary environment
Self-motivated, detail oriented, and able to prioritize and plan effectively
EDUCATION and/or EXPERIENCE:
BS/MS/RN/PharmD in related scientific field or equivalent. Minimum three plus years of experience in drug safety in the biotech/pharmaceutical industry. Vendor management experience preferred.