Drug Safety Case Specialist job in Philadelphia, USA

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Job type: Permanent

Discipline: Pharmacovigilance, Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a REMOTE Drug Safety Case Specialist with a biopharmaceutical company. This position supports the case processing organization to achieve its mission of improving patient lives globally through industry leading safety and compliance by consistent and accurate delivery of high quality, relevant and timely adverse event information.

Job Responsibilities:

Collect, assess and process adverse event information (clinical and post marketing) in a compliant and timely manner in order to comply with global regulations which includes:
o Seriousness assessment
o Labeling
o Causality
o Initial and Follow - up
Meeting company standards for quality, compliance and productivity. Remaining current on knowledge and skills required for case processing.
Meets case quality, case processing metrics and agility by exhibiting the company core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One; Decide Smart and Sure
Supporting and participating in audits and inspections as needed
Other duties may be assigned based on the need or work requirement of the organization.

Skills and Requirements:

Minimum: Bachelor's degree with related health sciences background, RN, BSN, BS, BS Pharm. Candidates lacking the appropriate degree but with previous pharmaceutical experience may be considered
2 years clinical experience strongly preferred.
Demonstrated ability to lead project work. Proven success in results-driven process management
Novice in case processing processes, procedures, conventions
Pharmacovigilance experience preferred
Aegis database experience preferred
Available to work a 40 hour work week Monday through Friday
Overtime may be needed based on the need or work requirement of the organization.
Holiday coverage may be needed based on the need or work requirement of the organization.

If you are having difficulty in applying or if you have any questions, please contact Kate Heffernan at 484-840-5183. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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