Patient Safety Surveillance Team Leader Job

Yoh has a contract opportunity for a PATIENT SAFETY SURVEILLANCE TEAM LEADER to join our client in Wilmington, DE.

JOB OVERVIEW:

The Safety Surveillance Team Leader serves as a pharmacovigilance resource for the generation and analysis of potential safety signals for investigational and marketed products within a therapeutic area. The Team Leader supports the Patient Safety Physician in maintaining accurate safety profiles of products within that area, manages the Safety Surveillance Groups aligned with key products or product groups within a therapeutic area, and drives the PSUR and other aggregate safety reports processes for products within that area for which the US has global responsibility.

JOB RESPONSIBILITIES:

- Supports the work of the Patient Safety Physician
- Submits accurate aggregate safety reports in a timely fashion
- Assures the completeness and accuracy of data provided to the Patient Safety Physician
- Provides regulatory safety expertise to the clinical teams
- Facilitates Safety Surveillance Group meetings under the direction of the Patient Safety Physician
- Participates actively in pre-SERM review and prepares/assists in preparation of SERM discussion documents for the GSP
- Provides organizational and scientific direction in aggregate safety reports (PSUR/IPAR, etc.) preparation, assuring that all contributors complete their assignments in a proper and timely way and that domestic and global requirements and timelines are satisfied
- Provides organizational and scientific direction in preparation of responses to health authority queries assuring that all contributors complete their assignments in a proper and timely way and that domestic and global requirements and timelines are satisfied
- Obtains accurate denominator data for signal evaluation and review
- Provides safety expertise to clinical trial working groups and clinical development teams, and presents the SAE reporting process at Investigator Meetings as necessary
- Contributes to multiple dimensions of people management, including recruitment, coaching, training/orientation, career development/growth, and team building

JOB QUALIFICATIONS:

- Advanced degree in science/healthcare-related field; or Bachelor's degree in science/healthcare-related field plus relevant equivalent experience.
- At least five years patient safety experience and/or at least five years clinical or pharmaceutical experience
- Excellent verbal and written communications skills
- Excellent presentation, personal and analytical skills
- Ability to synthesize and analyze complex medical and scientific data

PREFERRED JOB SKILLS/EXPERIENCE/KNOWLEDGE:

- M.P.H. or degree/training in epidemiology
- Previous pharmacoepidemiology experience or previous clinical research experience would be a plus

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Hannah Cihlar

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOBJ2WMIDATL

Ref:

SFSF: LS