Manager - Scientific - I in Foster City, CA at GDH

Date Posted: 6/23/2018

Job Snapshot

Job Description

Description:
Contractor, Drug Safety & Public Health (DSPH), S&C, Solicited Programs
Role Essential Duties and Job Functions:
Supports and manages activities related to solicited programs (e.g. Market Research, Patient Assistance Support Programs, and Digital Media).
Develops good relationships with internal and external organizations to facilitate and maintain safety reporting compliance within solicited programs.
Maintains oversight of Gilead required training activities for solicited program vendors.
Delivers appropriate safety information reporting training or advice to internal personnel and external organizations (e.g. new hire, sales, and solicited programs).
Assists in resolving reconciliation issues via communications with internal and external organizations.
Ensures good record keeping related to solicited programs, including maintenance of trackers supporting the Pharmacovigilance System Master File (PSMF).
Participates in training materials development and training logistics regarding solicited programs.
Monitors compliance with solicited programs training.

Other Essential Duties and Job Functions;
Able to establish work priorities and gather information on assigned tasks or activities for a given project with minimal direction from manager. May act as project lead.
Able to develop solutions to complex problems through ingenuity and innovation; ensuring solutions are consistent with organization objectives.
Works with applicable teams within DSPH, other functions, or external vendors to implement and maintain activities or tasks under the remit of S&C.
Recognizes the need for and seeks assistance from appropriate internal and external resources for projects with ability to recommend or clarify requirements/solutions or escalate concerns to Sr. Management.
Provides regular updates to manager, including challenges and suggested actions that could be taken, able to make recommendations for improvement.
Maintains compliance with DSPH and applicable SOPs and work instructions.
Maintains knowledge of company disease and therapeutic areas.
Participates in S&C meetings and shares information on projects and challenges openly.

Knowledge, Experience and Skills:
Note: The following represent common education and experience but not mandatory requirements.
Bachelor Degree in a relevant field, ideally medico-scientific or equivalent years of drug safety experience
Previous experience in drug safety or clinical research required, ideally 2-4 years
Experienced in training delivery
Proven excellent communication skills at all levels in the organization and evidence of ability to work in cross functional teams
Project management experience preferred or experience in managing complex projects
Good computerskills in Microsoft Excel, Word, and PowerPoint.
Has a good knowledge and understanding of applicable pharmacovigilance regulatory requirements and expectations regarding solicited programs and training
Demonstrates initiative, teamwork, and accountability
A quality driven individual with strong attention to detail and accuracy is required
Strong organizational skills and ability to adapt to changes
Onsite Offsite: Onsite Offsite Onsite