Talent Groups
Overview
Join to apply for the
Pharmacovigilance Scientist
role at
Talent Groups . Hybrid details: 3 days/week onsite. Duration: 7 months to start. Duties And Responsibilities
The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for assigned marketed and/or investigational product(s). The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. Demonstrates effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, may participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. Ensures activities remain compliant with evolving regulations, that SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports are adequate. Coordinate and document ongoing safety surveillance activities with the safety physician, including safety data review, signal validations, and signal evaluations. Lead aggregate report activities (PSUR/PADER/DSUR), 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 in conjunction with the safety physician and cross functional team members; perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization. Represent safety (with safety physician) in cross-functional product meetings. For investigational products: support activities relevant to investigational program including updates to Investigator Brochure, 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 related to the above activities. Contributes to initiatives for process improvement and cross-product process consistency. Other tasks as assigned or required. Qualifications
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, as well as with external colleagues. Demonstrated ability to prioritize multiple assignments and proactively identify solutions. Strong organizational, project management and leadership skills: leads and conducts 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 clinical trial safety regulations and post-marketing safety regulations; 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. Education
Advanced degree (PharmD, RN, MD, PhD, MPH, NP). Seniority level
Mid-Senior level Employment type
Full-time Job function
Other Industries
Staffing and Recruiting Waltham, MA Referrals information and job alerts have been removed for clarity and focus on the role.
#J-18808-Ljbffr
Join to apply for the
Pharmacovigilance Scientist
role at
Talent Groups . Hybrid details: 3 days/week onsite. Duration: 7 months to start. Duties And Responsibilities
The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for assigned marketed and/or investigational product(s). The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. Demonstrates effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, may participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. Ensures activities remain compliant with evolving regulations, that SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports are adequate. Coordinate and document ongoing safety surveillance activities with the safety physician, including safety data review, signal validations, and signal evaluations. Lead aggregate report activities (PSUR/PADER/DSUR), 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 in conjunction with the safety physician and cross functional team members; perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization. Represent safety (with safety physician) in cross-functional product meetings. For investigational products: support activities relevant to investigational program including updates to Investigator Brochure, 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 related to the above activities. Contributes to initiatives for process improvement and cross-product process consistency. Other tasks as assigned or required. Qualifications
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, as well as with external colleagues. Demonstrated ability to prioritize multiple assignments and proactively identify solutions. Strong organizational, project management and leadership skills: leads and conducts 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 clinical trial safety regulations and post-marketing safety regulations; 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. Education
Advanced degree (PharmD, RN, MD, PhD, MPH, NP). Seniority level
Mid-Senior level Employment type
Full-time Job function
Other Industries
Staffing and Recruiting Waltham, MA Referrals information and job alerts have been removed for clarity and focus on the role.
#J-18808-Ljbffr