Pharmacovigilance Project Manager FullTime
Roles : 3-5 years in Pharmacovigilance Project Management
Qualifications
- Experience in Pharmacovigilance Project Management (preferably in a CRO).
- Bachelor’s in Pharmacy, Life Sciences, Medicine (Master’s is a plus).
- Expertise in ICSR processing, PADERs, DSURs, PSURs, RMPs, signal management &literature monitoring.
- Strong project management, team coordination & client-facing skills.
- Proficiency in MS Office & project management tools.
- Excellent communication, multitasking & compliance handling abilities.
- Ability to manage multiple projects while ensuring high-quality standards.
Roles and Responsibilities
- Serve as the primary point of contact for project-related communications withboth external and internal stakeholders.
- Establish and maintain strong client relationships, ensuring consistent delivery ofhigh-quality work and addressing any concerns promptly.
- Develop project scope, timelines, and objectives based on the signed agreementbetween the client and Navatio Pharma.
- Plan, track, and manage project activities, ensuring deadlines are met andmilestones are achieved on time.
- Oversee and report project progress, providing regular updates to clients andinternal stakeholders (e.g., Monthly reports, used for invoicing and performancetracking).
- Monitor and manage project budgets, resource allocation, and timelines to ensureefficient project execution.
- Ensure compliance with relevant regulatory requirements and adherence to internalSOPs and Quality standards.
- Facilitate project meetings, ensure clear communication of goals, and resolve anyissues that may arise during the project lifecycle.
- Coordinate with cross-functional teams (e.g., safety operations, medical affairs,regulatory affairs) to ensure successful project execution.
- Support the preparation and submission of safety reports, such as PADERs, PSURs,DSURs, and other regulatory documents.
- Train and mentor staff in pharmacovigilance processes, regulatory requirements, andbest practices.
- Prepare for and support pharmacovigilance audits and regulatory inspections.
- Implement corrective actions as necessary following audits and inspections.
- Stay up to date with the latest trends and regulatory changes in pharmacovigilance.
Join us and be a part of a dynamic team ensuring patient safety worldwide!Apply now or refer a suitable candidate!Email your resume to:: hr@navatiopharma.com