Drug Safety Senior Specialist

Peak Performers has partnered with a pharmaceutical company to assist in their search for a hybrid Drug Safety Senior Specialist in Waltham, MA. In this position, you will participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. Major duties • Coordinate and document ongoing safety surveillance activities with the safety physician. Activities will include safety data review, signal validations, signal evaluations • Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks. • Manage literature review plan for assigned product(s) and provide feedback to vendor on routine literature surveillance activities • In conjunction with the safety physician, prepare materials for routine and ad hoc Safety Governance meetings (product- and leadership-level meetings). • Coordinate responses for ad hoc safety queries (eg, health authority requests, NISS, or health hazard evaluations) in conjunction with the safety physician and cross functional team members, as needed. • Perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization. • Represent safety (with safety physician) and cross functional product meetings • Support activities relevant to investigational program including (but not limited to): • Routine/ad hoc updates to safety content of Investigator Brochure (IB), safety content of protocols, CRFs, ICFs • Routine DSMB presentations • Ongoing data review, including lab and AE data review • Maintain strong working knowledge of relevant regulations associated with the above activities. • Contributes to initiatives for process improvement and cross-product process consistency. What are we looking for? • Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist role. • Demonstrated experience in analysis and interpretation of medical and scientific data and excellent verbal and written skills. • Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues • Demonstrated ability to prioritize multiple assignments and proactively identify solutions, as needed • Strong organizational, project management and leadership skills: Leads and conducts (independently and/or collaboratively) all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. • Oversees and mentors less experienced PV Scientist staff. • Demonstrated clinical judgment to interpret case information. • Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts. • Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects), MedDRA, and Argus Safety System Exciting Opportunity Details • Rate: $73.00/hour • W2 Contract • Worksite Location: Waltham, MA • Hybrid • 6 month contract The Peak Performers difference • Excellent medical health, dental & vision insurance at 60 days • Our employees may choose to participate in a 403(b) retirement plan • Qualified applicants with chronic medical conditions and/or disabilities receive priority placement • We pay weekly through direct deposit • In business since 1994 and thousands of job placements All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws. Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future. Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.