Pharmacovigilance Manager

Job Responsibilities:

1. Collaborate with safety physicians to analyze and manage potential safety issues, including signal detection, evaluation, and management.
2. Engage with study teams, cross-functional partners, and vendors to address safety challenges within therapeutic areas.
3. Contribute to signaling and data mining activities using internal and external data sources such as Empirica, clinical outputs, literature, and health authority (HA) requests.
4. Support safety evaluations and quality risk assessments using established processes and templates.
5. Prepare reports, minutes, and documentation for safety committees; ensure action items are completed and patient safety issues are addressed.
6. Provide timely and clear communication to cross-functional teams, including scheduling and leading meetings to resolve safety issues.
7. Co-author aggregate safety reports (e.g., PSUR, DSUR, Line Listings) alongside safety physicians and operational teams.
8. Assist with the development and review of Safety Management Plans (SMPs) and External Safety Reporting Plans (ESRPs).
9. Provide training and management support for new team members on department practices and therapeutic areas.
10. Identify process gaps and recommend or initiate improvements.
11. Develop and implement data dashboards for signaling, compliance, and KPIs/QPIs.

Education and Experience:

• Required Degree: MSN RN, PharmD, Physician Assistant, MD, or equivalent in a medical/healthcare-related discipline.
• Experience: 3–5 years in drug safety/pharmacovigilance within the pharmaceutical industry.
• Preferred Experience:
• Clinical patient care background.
• Expertise in global pharmacovigilance regulatory requirements (US, EU, LATAM, APAC).
• Familiarity with Argus, Arisg, Empirica, and Spotfire.
• Skills in data display development (dashboards) for compliance and signaling.
• Experience working across diverse geographies and business settings.

Special Skills:

• Effective in matrix environments and cross-functional collaborations.
• Strong scientific writing, planning, and organizational skills.
• Ability to manage risk management plans across a product's lifecycle.
• Diplomatic problem-solving and negotiation skills.
• Expertise in process improvement and business solutions.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.