Sr. drug safety associate - united states, zaranj

job number: 43744

job description:

case processing - 60-65% of time: completion of full case information on the database, including quality review to ensure accuracy and completeness triage of incoming cases to prioritize for daily workflow management completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval preparation of analysis of similar events perform quality review of individual case safety reports (icsr) which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated. liaise with global case receipt and/or physicians staff as appropriate to clarify appropriate information required for case processing other activities relating to case processing as appropriate per case, including but not limited to: o single case & end-of-study unblinding, serious adverse event (sae)/adverse event (ae) reconciliation, deviation memo preparation, deletion requests and approvals, review protocol updates for accuracy vendor oversight activities for assigned products: product portfolio subject matter experts operational management activities for onshore teams and vendors, including but not limited to: o workload and productivity monitoring activities, workload meetings, vendor meetings, monitoring quality of icsrs team leadership - 5% of time: close liaison with senior drug safety associate regarding process and workload management and deputizes for manager as identified. takes the lead in team meetings and daily liaison with team members to identify and resolve processing issues assists manager with implementation of processes, and issue management supports and deputizes for manager as identified product-specific daily workload - 5% of time: prioritization and organization of team workload to maintain regulatory compliance and quality standards review workload to prioritize and ensure compliance with processing timeframes review regular icsr data consistency reports to identify processing inconsistencies and errors monitor aggregate reporting calendars to ensure cases are processed in required timelines processes & procedures - 5-10% of time: awareness of and input to company procedures and guidance completion of all assigned training on company procedural documents relating to case processing completion of training relating to relevant pharmacovigilance (pv) agreements for assigned products participate in designated activities to support revision/creation of case processing procedural documents promotion of awareness of procedural document requirements within team project work - 10% of time: participation in assigned projects, including inspection/audit readiness activities participation in local or global project teams, including on-time delivery of assigned responsibilities participation in inspections and audits as identified, including interviews and provision of requested data assistance in preparation or implementation of corrective/preventative actions relating to case processing mentoring & supervision - 5% of time: oversight of mentoring of case processing (or other identified) staff, and involvement in recruitment and supervision. regular meetings with mentors in case processing, and completion of mentoring checklists/documents provision of the on-the-job training and mentoring of drug safety associate (dsa) staff participates in candidate interviews and may assist in on boarding of new hires supervision of contractor dsas as identified process & product expert: act as key contact or point of expertise for team members and external contacts for designated products or processes personal development - 5% of time: continuous development of personal skills whether task or competency-related activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development perform other related duties as required - 5% of time maintains compliance with company guidelines and hr policies education & experience requirements: education: registered nurse or pharmacist (certification/licensure is required e.g. rn, rph, pharmd). health/biomedical degree (bs, phd or other related scientific degree/qualification). licensed practical nurse with bachelor's degree, or with knowledge of pharmacovigilance usually exhibited by minimum 4 - 6 years? experience in pharmaceutical safety-related role. pharma experience: 4+ years of pharmaceutical industry experience is required, with experience in pharmaceutical safety related areas. case processing experience is desired. knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred. required skills, abilities and competencies include: practical knowledge of global regulatory pharmacovigilance requirements understanding of medical terminology and ability to summarize medical information ability to follow guidelines and procedural documents (experience of working with sops etc preferred) oriented to quality, attention to detail and accuracy manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines ability to effectively delegate work responsibilities to others ability to work both independently and in collaboration with others proactive approach/uses own initiative appropriately decision-making and problem-solving skills flexibility and adaptability positive attitude other skills: good verbal and written communication skills good computer skills (word, email) and familiarity with safety systems knowledge or experience with excel, powerpoint, visio preferred

responsibilities:

education requirements:

education & experience requirements:

education:

registered nurse or pharmacist (certification/licensure is required e.g. rn, rph, pharmd).

health/biomedical degree (bs, phd or other related scientific degree/qualification).

licensed practical nurse with bachelor's degree, or with knowledge of pharmacovigilance usually exhibited by minimum 4 - 6 years? experience in pharmaceutical safety-related role.

desired background/skills:

other skills:

good verbal and written communication skills

good computer skills (word, email) and familiarity with safety systems

knowledge or experience with excel, powerpoint, visio preferred

qualifications:

pharma experience:

4+ years of pharmaceutical industry experience is required, with experience in pharmaceutical safety related areas. case processing experience is desired.

knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred.

required skills, abilities and competencies include:

practical knowledge of global regulatory pharmacovigilance requirements

understanding of medical terminology and ability to summarize medical information

ability to follow guidelines and procedural documents (experience of working with sops etc preferred)

oriented to quality, attention to detail and accuracy

manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines

ability to effectively delegate work responsibilities to others

ability to work both independently and in collaboration with others

proactive approach/uses own initiative appropriately

decision-making and problem-solving skills

flexibility and adaptability

positive attitude

other information:

greene resources is committed to creating a diverse environment and is proud to be an equal opportunity employer. all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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