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Our client, a large pharmaceuticals manufacturer, has an immediate need for an experienced Pharmacovigilance Med Safety Global Case Manager to join their team. If you have excellent communication and the following skills, we would love to speak with you!

Key Responsibilities

Responsible for operational oversight of vendor staff involved in case receipt, case processing, and safety reporting. In addition to liasing with vendor partner(s) and resolving potential issues.
Expertise in operational activities including case processing. Providing subject matter expertise in pharmacovigilance (PV) and global/local AE regulatory reporting requirements.
Identifies and implements process efficiencies and continuous quality improvements to support business objective of cost-efficient sustainable and scalable end to end case management solutions.
Support development of standard operating procedures, work instructions and training to support case management activities; ensuring vendor is adequately trained.
Supports internal audits and external inspections and develops corrective and preventative actions to address non-conformances.
Participates in cross-functional governance teams to ensure alignment of priorities among key business partners.
Performs other related duties as the need arise

Requirements

A minimum of a Bachelor's degree in life sciences or health-care field with 5 years of experience in Pharmacovigilance OR an Advanced degree (e.g., MS, MPH, PharmD, or PhD) with 3-5 years of experience in Pharmacovigilance or related activities, industry activities preferred.
Demonstrated experience working in a matrix environment and cross-functional teams.
Practical knowledge of global and local regulatory pharmacovigilance requirements.
Understanding of medical terminology and ability to summarize medical information.
Ability to view the "big picture" and understand impact of decision taken within the team or function.
Working knowledge of safety databases to identify system enhancements and efficiencies including MedDRA and product dictionaries and version updates is strongly preferred.
Experience working on CAPAs is strongly preferred.
Experience authoring and editing controlled documents (e.g., SOPs) is strongly preferred.

Benefits

A comprehensive benefits package which includes medical, dental, vision, disability and life insurance, 401k and a generous PTO Policy.

About Endeavor:

At Endeavor Consulting Group, our mission is to provide straightforward solutions to complicated situations. As a specialty project management technology and integration firm, we are laser focused on Operational Systems, Supply Chain Integration, and Product Development for Life Sciences enterprises. Our team is driven, energetic, and passionate about delivering results and earning the trust of our ever-expanding client base.

We are dedicated to building a thriving company culture and a workplace environment that fosters respect, honesty, and creativity. Our goal is to help our clients triumph; to do that, we must remain fiercely committed to ensuring the happiness and fulfillment of our employees. In pursuit of excellence, we look for individuals with a customer-focused approach to problem-solving, a desire to exceed expectations, a philanthropic point of view, a dedication to quality service, and a strong technological background.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We are committed to providing accommodation for employees with disabilities.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

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