Pharmacovigilance Safety Scientist (2018-29252)

Comrise Horsham , PA 19044

Posted 7 months ago

Job Description

POSITION SUMMARY:

The Scientist will be responsible for assigned tasks related to core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (small to medium volume, standard complexity). Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. The Scientist will partner with team members, stakeholders, and a vendor.

PRINCIPAL RESPONSIBILITIES:

85% of the time:

Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate

Collaborate with PVER team members to perform assigned tasks, Interact with other stakeholders (e.g Safety Surveillance Physician (SSP), Medical Safety Officer (MSO)) on relevant deliverables

Initiate/conduct searches of internal and external databases

Perform aggregate safety analysis and case level review

Author/contribute to the preparation of core safety deliverables

Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs), assessment reports) are met as appropriate for assigned tasks

Partner with vendor to develop reports/deliverables

15% of the time:

Training/Meetings/Department Initiatives

Participate in department training

Training of task or process-related activities

Participate in department initiatives as appropriate

EDUCATION & EXPERIENCE REQUIREMENTS:

Bachelors Degree in Health or Biomedical Science (3-5 years industry experience or equivalent)

Advanced Degree Preferred in Health or Biomedical Science (2 years industry experience or equivalent)

Clinical/Medical writing or PV experience preferred

Strong English verbal and written communication skills

OTHER REQUIREMENTS:

Scientific Skillset: Analytic and Conceptual Skills

Independence: Minimal independence; (Contributor/Co-lead)

Knowledge (Product and Regulations): Safety Management Team (SMT) support when needed

Awareness of applicable global, regional, and local regulatory requirements (e.g., ICH guidelines)

Company Description

Comrise is the bridge to first-rate talent for organizations that recognize the value of their workforce. With locations in the U.S., China, and Hong Kong, we help our clients reach far and wide for both local and international resources which yield the highest return on their human capital investments.Headquartered in New Jersey since 1984, Comrise is a staffing, consulting and enhanced search technology company. For over 30 years we have delighted our clients and consultants by focusing on customer satisfaction, innovation and flexible workforce solutions. By combining our global networks with our outstanding local offices, Comrise provides high quality executive search, temporary and temporary to permanent staffing solutions, and cross border placement services.
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Pharmacovigilance Safety Scientist (2018-29252)

Comrise