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Senior Project Manager (Pharmacovigilance)
Posted 23 days agoViewed
💎 Seniority level: Senior
📍 Location: United States
🔍 Industry: Pharmaceutical
🏢 Company: Clinigen👥 251-500PharmaceuticalIndustrialManufacturing
🗣️ Languages: English
Requirements:
- Prior experience working in a contract research organization (CRO), pharmaceutical and/or biotech company.
- Broad working knowledge of Clinical and/or Post-marketing PVG and safety reporting requirements under the FDA/International regulations, ICH/GCP guidelines and other relevant requirements.
- Effective communicator (written and oral); concise, accurate and business appropriate
- Excellent attention to detail and effective organization
- Demonstrated critical thinking and problem-solving skills
- Ability to manage multiple tasks with deadlines
- Proven effective collaboration with other functional areas
- Excellent interpersonal skills
- Computer literacy in MS Word, Excel and PowerPoint.
Responsibilities:
- Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans, safety documents, SOPs and guidelines to reflect specific work processes.
- Assist with Safety Management Plan development and safety database configuration and ensure project team is up to date on all relevant changes.
- Ensure that relevant data is entered and maintained in the safety database system in collaboration with the Medical/Safety business unit.
- Ensure Pharmacovigilance files for assigned projects are properly maintained and/or provided to Records Management in a timely manner.
- Manage communications between appropriate team members, Clients, and Sponsors when safety issues are identified.
- Participate in training sessions and workshops, including presenting reports from any conferences attended, as agreed.
- Monitor compliance metrics, project budgets, and service level agreements for assigned projects to ensure regulations and timelines are being met and activities performed are within the approved budget.
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