Drug Safety Specialist

Purpose: Our client, located in the North Bay, has an immediate opening for a Drug Safety Specialist.

General Purpose of the Position:
Key functions of this position will include but not limit to the initial assessment, safety data handling, narrative creation and case closure for incoming AEs/SAEs within the company products covering pre-and post-market activities. This position will also be responsible for study-specific AEs/SAE reconciliation between safety database and clinical database, as applicable, as well as for the ongoing safety surveillance of clinical trial subjects, including regular monitoring.

Essential Functions and Responsibilities:
- Provide safety and pharmacovigilance surveillance for clinical and post-marketed products by assessing, processing and finalizing adverse event reports as per department guidelines and standard operating procedures/policies (60%)
- Independently generate safety queries for SAEs to address discrepancies within case files and lead in the preparation and submission of expedited reports to relevant partners and relevant regulatory authorities (10%)
- Present serious adverse event processing issues at meetings with investigators and study site personnel for new study products (5%)
- Collect safety information to study serious adverse events and fulfill surveillance program requirements for healthcare products. Meet reportability deadlines (5%)
- Maintain and update departmental guidelines and SOP's, assure that SOP's are consistent with departmental work processes (10%)
- Manage safety data handling and evaluate, investigate and accurately complete database SAE/AE case processing using clinical expertise for evaluation reports, support the regulatory and medical triage of AEs received, determine additional clinical information requirements needed for AEs, narrative formulation and case assessment
- Distribute all safety information on investigational marketed and post-marketed drugs from international and local sources by conducting adverse events and searching medical literature (10%)

Minimum Qualifications:
- A Healthcare professional (RN, BSN, NP, MSN) with at least 2-3 years experience in the pharmaceutical, biotech or clinical research industry, including experience with processing and reporting of SAEs,
- Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements, International Conference on Harmonization Experience and knowledge in MedDRA coding preferred
- Proficiency in the management of adverse events, safety database (ARISg experienced preferred), clinical knowledge of the General Medicine and respiratory disease therapeutic areas.
- Proficiency in Microsoft Office applications, literature searching and Internet navigation required.
- Must have excellent verbal and written communications skills.
- Excellent interpersonal skills, medically accurate, fair-balanced and team-building skills are mandatory.

Please email resumes to