Pharmacovigilance Project Director

THE POSITION:

This position serves as the primary client-facing pharmacovigilance director responsible for strategic oversight operational governance and delivery excellence across assigned client programs. The role provides leadership across pharmacovigilance operations client governance inspection readiness regulatory compliance and service delivery while ensuring successful execution of project milestones and achievement of client objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by

• Serve as the primary point of contact for assigned clients building trusted relationships and ensuring a high level of customer satisfaction.
• Utilize project management principles to plan track and drive delivery of milestones risks dependencies and action items.
• Lead governance meetings operational reviews and client communications.
• Lead governance forums status meetings and executive reviews providing clear communication on project progress and key decisions.
• Proactively identify manage and resolve client concerns risks and escalations to ensure successful project outcomes.
• Coordinate cross-functional teams to ensure alignment accountability and timely execution of client commitments.
• Provide oversight of case processing aggregate reporting literature surveillance signal management and regulatory submissions.
• Drive development and maintenance of Safety Management Plans.
• Drive service delivery excellence through continuous monitoring of KPIs quality metrics and client feedback ensuring contractual and operational expectations are met or exceeded.
• Ensure compliance with FDA EMA ICH and client-specific requirements.
• Support audits inspections CAPA management and regulatory inquiries.
• Monitor project financials including billing invoicing resource utilization and budget performance.
• Demonstrate a commitment to diversity equity and inclusion through continuous development modeling inclusive behaviors and proactively managing bias.
• All other duties as assigned

EXPECTATIONS OF THE JOB:

• Travel (Less than 15%)
• Hours (40-45 Hours per week)

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

Qualifications :

MINIMUM KNOWLEDGE SKILLS AND ABILITIES:

The requirements listed below are representative of the experience education knowledge skill and/or abilities required.

• Education bachelors degree in Life Sciences Pharmacy Nursing or related discipline.
• Experience and/or Training
  • 10 years of pharmacovigilance experience.
  • 5 years of client-facing project leadership experience.
  • Strong knowledge of FDA EMA ICH and global PV regulations.
  • Experience supporting inspections and audits.
  • Experience overseeing end-to-end pharmacovigilance services.
  • Excellent communication stakeholder management and presentation skills.
  • Ability to manage multiple complex client programs and priorities.

PREFERRED QUALIFICATIONS:

• Education Advanced degree in Life Sciences Pharmacy Nursing or related discipline.
• Experience and/or Training
  • CRO or pharmacovigilance services experience.
  • Experience managing pharmaceutical and biotechnology clients.
  • PMP certification preferred.
  • Experience with project management tools.
  • Demonstrated record of client satisfaction and operational excellence.
  •  

PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Office: While performing the essential functions of this job the employee is frequently required to reach grasp stand and/or sit for long periods of time (up to 90% of the shift) walk talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet with frequent interruptions and multiple demands.

Additional Information :

OUR CULTURAL BELIEFS:

Patient Minded I act with the patients best interest in mind.  

Client Delight I own every client experience and its impact on results.  

Take Action I am empowered and empower others to act now.  

Grow Talent I own my development and invest in the development of others.  

Win Together I passionately connect with anyone anywhere anytime to achieve results.  

Communication Matters I speak up to create transparent thoughtful and timely dialogue.  

Embrace Diversity I create an environment of awareness and respect.  

Always InnovateI am bold and creative in everything I do. 

EVERSANA is committed to providing competitive salaries and benefits for all employees. The anticipated base salary range for this position is $120000 to $135000 and is not applicable to locations outside of the U.S.  The base salary range represents the low and high end of the salary range for this position.  Compensation will be determined based on relevant experience other job-related qualifications/skills and geographic location (to account for comparative cost of living).  EVERSANA reserves the right to modify this base salary range at any time.

Our team is aware of recent fraudulent job offers in the market misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites unsolicited e-mails or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S.  Compensation will be determined based on relevant experience other job-related qualifications/skills and geographic location (to account for comparative cost of living). This role is eligible for hire in select U.S. locations based on business and operational considerations. For a full list of locations visit  information about EVERSANAs benefits package can be found at  EVERSANA reserves the right to modify this base salary range and benefits at any time. 

From EVERSANAs inception Diversity Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer and our employees are people with different strengths experiences and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity but also age disability status veteran status sexual orientation religion and many other parts of ones identity. All of our employees points of view are key to our success and inclusion is everyones responsibility.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process please contact us at .

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Remote Work :

Yes

Employment Type :

Full-time