Scientific Manager

Contractor, Drug Safety & Public Health (DSPH), S&C, Solicited Programs Confidential 1 August 2016

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

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.

Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - (732)-844-8715

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)