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 Client 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 computer skills 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 change
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 computer skills 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 change
Kind Regards,
Sabanaaz Shaikh
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
