Pharmacovigilance and Medical Safety Officer

Our client, a global leader in the Personal Care, OTC, and Cosmetics industry, is in immediate need of a **Pharmacovigilance and Medical Safety Operation** **Subject Matter Expert** to join their pharmacovigilance team.

Pharmacovigilance and Medical Safety Officer should have a blended background with experience in understanding the operations of a Medical Safety Support Desk, as well as the Argus systemdictionary set up, distribution rules, experience in understanding User requirements, and User acceptance testing.

This role requires Project Management experience and an analytical mindset.

**Responsibilities**
- Knowledge of Argus safety database system
- Work with Project Management team, responsible for communication of project status to all project stakeholders.

Communication includes project meeting minutes, and any status or project detail information.
- Working on Business Analytics for major GxP compliant systems
- Ensuring all Pharmacovigilance operations are completed successfully
- Review of global medical literature related to Consumer products or Pharma
- SME for literature review team, provide trainings to new hires and various teams
- Responsible for Processing and quality review of Individual Case Safety Reports (ICSR)
- Triage and prioritization of ICSRs
- Ensure Compliance monitoring of late ICSRs: RCA, CAPA and trainings
- Drafting Periodic Safety Update Reports (PSUR) and Risk Management Plans (RMP)
- Participation in audits and MHRA inspection
- Review of procedural documents (eg: Data migration plan) for correctness of information prior to their approval
- Review User Requirements Specification
- Review UAT scripts and UAT execution
- Understand the functions related to the UAT being reviewed: Safety database, Case processing, reporting rules etc
- Coordinate with vendor team for issue resolution
- Coordinate with business or process owners for clarification of operational functions
- Provide Project Management for a Consumer support project
- Help in preparation of PPTs

**Requirements**:
**Required Qualifications**
- Education: Bachelor’s degree in health sciences or equivalent
- Work experience in Cosmetics, OTC or Pharma industry

**Benefits**

**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.

**Want to learn more?**
- Check out our website: Endeavor Consulting Group | Solutions Made Simple
- Follow us on LinkedIn: Endeavor Consulting Group | LinkedIn