PV Scientist, Contractor, Safety Risk Management 6 Months Remote
Summary of Key Responsibilities
- Works closely with the safety lead physician to analyze potential safety issues, including signal detection, signal evaluation and signal management.
- Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
- Contribute to signaling and data mining activities utilizing internal and external sources of data.
- Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
- Assists in evaluation and development of Safety Management Plans
- Assists in data analysis compilation and presentation at cross-functional meetings.
- Assists in the evaluation of potential safety issues.
- Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
- Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
- Assists in RMP and DRMP development and updates.
- Supports authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions
Qualifications
Education
- Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required
Experience
- A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.
- Previous experience in managing drug safety personnel a plus.
- Specific experience in RNA therapeutic area at a global level is an advantage.
Skills and Competencies
- Strong skills and experience in:
- Ability to work in a matrix environment in accordance with the company leadership commitments and values.
- Excellent planning, organization, written and oral communication skills
- Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
- Understanding Signaling tools (eg. Empirica)
- Experience in clinical patient care is a plus
- Regulatory Inspection readiness experience is a plus
Supervision
- Individual is expected to work independently with support from management and colleagues in SRM.
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- We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
- TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.