Onsite, PA
No remote work possible
Main Focus:Manage the production of aggregate reports for assigned products (small to medium complexity reports) including planning, conducting meetings, writing, coordination of production and modification, assembly in documentum and addressing questions. Perform quality reviews for PVAR peer reports. In this position, one would author regulatory documents including PSURs. Experience writing PSURs is required. Knowledge in drug safety, pharmacovigilance and regulatory affairs, within the pharmaceutical industry is necessary to be most successful.
Principal Responsibilities: Ensure timely, quality aggregate reports for assigned products.
Liaison with colleagues as appropriate to guide report content in planning.
Data quality review/correction.
Quality review of team members' work.
Attend team meetings, departmental meetings, required training, and related activities.
Decision Making and Problem Solving: Describe the types of decisions which are made, reviewed or referred. Describe the types of problems solved or referred.
Indicate the degree to which decisions made and problems solved are circumscribed by procedure, policies, standards, or regulations.
Evaluate comments from reviewers of draft reports for appropriateness and respond accordingly.
Constantly (re)prioritize work to manage projects often requiring multitasking skills.
Data cleaning/QC skills.
Reporting Relationships:
This position reports to Manager, Aggregate Reports and Analysis, Integrated Operations.
Responsibility for Others:Describe the nature of supervision exercised over others by this position. Please ensure that it shows the incumbent's name and position titles of peers, staff and supervisor.
Include regular/casual full-time and part-time employees, temporaries, co-ops, consultants, etc.
Education and Experience Requirements:
Required: Bachelor's degree in health or biomedical science (+2 years industry experience)
Preferred: Graduate degree in health or biomedical science (PharmD, PhD, MPH, or MD; +0-2 years industry experience)
Awareness of Global Culture and Drug Safety
Drug Safety Experience (case management, spontaneous, solicited and clinical, familiarity with safety database)
Writing experience and competence (samples and extemporaneous)
Project management experience
Excellent verbal and written communication skills (formal, e-mail and teleconference); ability to communicate in a global environment
Microsoft Word competence (tables, basic formatting)
Documentum systems familiarity preferred
Global Safety-Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to pharmacovigilance) preferred
Windows OS familiarity/maneuverability
MS Excel skills
Web-based program/Internet competence
Contact:
Jessica Leveille
Manager, Biomedical Delivery Services at Orbis Clinical
Direct line (781) 496-3133
Direct fax (866) 855-5872
Email
JLeveille@orbisclinical.com
