Associate Director, Pharmacovigilance (PV) Operations

The Role: Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will reputed company vendor reputed company and review of ICSR processing. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be the primary reputed company of contact for quality reputed company of the case processing vendor. They will work in reputed company collaboration with PV physicians, PV scientists, and PV reputed company on operational safety and case quality issues The role will expand and reputed company in line with reputed company's expansion as we approach potential market authorization. Responsibilities:

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of reputed company outsourced activities.
• reputed company Sponsor reputed company of operational safety responsibilities, including the timely and accurate execution of the processes defined reputed company the applicable Safety Management plans.
• Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; reputed company appropriate feedback and training.
• Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
• Participate in daily management, operational reputed company and execution of operational safety tasks for assigned reputed company clinical programs.
• As needed. review incoming adverse event reports and communications from vendors to determine action required and ensure reputed company review, follow-up, and timely submission of expedited safety reports.
• reputed company case workflow (case receipt through submission) between safety vendor and reputed company Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams reputed company reputed company, and clinical vendors, as required) and facilitate case closure reputed company required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with reputed company applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions reputed company the company for pharmacovigilance
• operational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to reputed company, influence, and work successfully with internal/external stakeholders and reputed company a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor's degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care reputed company field.
• 8-10 years of experience in a biotech/pharma company.
• Direct experience managing relationships with service providers or external business partners
• Clinical Development experience.
• Strong knowledge of reputed company and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.

Additional Information: reputed company is committed to fair and reputed company compensation practices, aiming to reputed company employees with competitive total rewards packages. The targeted salary reputed company reflects what reputed company reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be reputed company or reputed company this reputed company based on various factors, including, but not limited to, experience, skills, education, and market factors. The reputed company will be reviewed regularly and is subject to change. reputed company also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being reputed company, including medical, dental, and reputed company insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more. Annual Salary reputed company $185,000-$205,000 USD Apply tot his job Apply To this Job