Operations Specialist 2, Pharmacovigilance
hace 2 meses
External Job Description
**Job Overview**
**Key Responsibilities**
- Process Safety data as per regulations, guidelines, SOPs, and project requirements.
- Perform Pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AE)/endpoint information, database entry, coding AE and Products, writing narratives, and more.
- Assess Safety data for reportability to relevant authorities and report within timelines.
- Contribute to or lead deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance, and Medical Information.
- Ensure quality, productivity, and delivery standards are met.
- Build a positive team environment, provide training and mentoring for less experienced team members.
- Provide technical and process information to Safety Management and operational team on project-specific issues.
- Maintain a thorough understanding of project protocol, therapeutic indication, budget, and scope of work (SOW) for assigned projects.
- Attend project team meetings and provide regular feedback/inputs to Operations team manager on operational project metrics, challenges, and successes.
- Contribute to the achievement of departmental goals.
**Qualifications**
- Bachelor’s Degree in a scientific or healthcare discipline or allied life sciences.
- Up to 4 years of relevant experience, inclusive of up to 2 years of Pharmacovigilance experience.
- Excellent knowledge of medical terminology.
- Excellent organizational skills, time management skills, attention to detail, and accuracy.
- Proven ability to work independently and autonomously with policies and practices.
- Ability to work effectively on multiple projects simultaneously, organize own workload, and effectively manage teams’ priorities.
- Flexibility to operate in shifts.
LI-Remote
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