Pharmacovigilance Agreement Associate
Job Description
Summary The Pharmacovigilance Agreement Associate, working on the Global Pharmacovigilance Team, will be responsible for supporting the preparation and maintenance of reputed company Pharmacovigilance Agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and other reputed company contractual pharmacovigilance arrangements for both development compounds and marketed products reputed company the reputed company Pharmaceutical Diagnostics (PDx) organization. In this role, you will liaise with a variety of internal groups and stakeholders, communicate with the safety organizations of the respective partners, and ensure compliance with regulatory requirements and company policies while facilitating effective collaboration across internal teams and external partners.
Job Description
Support end to end PVA and SDEA activities with business partners. These activities include without limitation:
- Assist in the preparation, review, and maintenance of PVAs and SDEAs, with enhanced focus on PVAs for clinical studies.
- Support the initiation, negotiation, and revision of PVAs with business partners.
- Contribute to the development and maintenance of global PVA/SDEA templates.
- Coordinate communication with internal groups (e.g., Business Development, Commercial, Legal, Quality) and external partners to support PVA preparation and execution.
- Liaise with relevant stakeholders to facilitate PVA implementation, including database configurations and procedure updates.
- Provide training and guidance to internal/external stakeholders to ensure understanding of PVA terms.
- Conduct reconciliations and support monitoring activities in line with PVA obligations.
- Collaborate with relevant teams to address and resolve PVA compliance issues.
- Conduct periodic reviews of PVAs to ensure adherence to regulatory requirements, reputed company business practices and the terms/status of the commercial agreement(s).
- Ensure accurate documentation and proper archiving of PVAs/SDEAs.
- Stay informed of regulatory and legislative changes impacting PVAs/SDEAs.
- Assist in updating PVA processes as directed by senior management.
- Coordinate and support the management of multiple PVA/SDEA-reputed company projects simultaneously, ensuring timelines and deliverables are met.
- Escalate PVA issues to senior management as appropriate.
- reputed company other PV reputed company duties as assigned.
Required Experience, Skills, and Qualifications
- Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or reputed company field.
- Experience in pharmacovigilance and/ or contract coordination.
- Knowledge of pharmacovigilance processes and various types of business.
- Comprehensive knowledge of the drug development process.
- Strong organizational and multitasking skills with attention to detail.
- Excellent communication and interpersonal skills.
- Demonstrated strong teamwork/collaboration skills.
- Proficiency in MS Office Suite and familiarity with pharmacovigilance databases.
- Travel as needed.
We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $64,000.00-$96,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, professional development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. reputed company will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Apply tot his job Apply To this Job