Job Description
Roles and Responsibilities
Subject Matter Expert [AM1] for the processes supporting preparation of aggregate reports (Periodic Benefit-Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR) and other reports) under the team responsibility
- Data collection and preparation of selected PSUR sections, QC, finalisation of PSURs, PSUR distribution,
- May author certain parts of PSURs,
- Review and QC of selected PSUR sections performed by the team,
- Demonstrate knowledge in pharmacovigilance, which includes understanding of relevant aspects of laws, regulations and guidance,
- Making sure all PSUR-related activities under team responsibility are performed in line with applicable global regulations and guidelines,
- Ensuring the existence of related SOPs, Wls, and/or training materials,
- Serves as SOP/WI reviewer for the relevant areas,
- Discover training needs and provide training, coaching and mentorship,
- Set up the process, evaluate it and implement changes/improvements when needed,
- Build collaborative working relationships with other functions in Teva,
- Representing the area in any audits or inspections
- [AM1]Responsible approach to work duties
- Excellent attention to detail and organizational skills
- Ability to manage multiple tasks and prioritize workload
- Process-oriented and critical thinking
- Independent problem solving and decision-making skills
- Ability to effectively train and mentor
- Excellent interpersonal and communication skills
Desired Candidate Profile
- University degree (bioscience background)[AM1]
- Fluent in English, both written and spoken
- MS Office skills
- In-depth knowledge of international pharmacovigilance regulations
- Minimum 10 years of experience (6+ years of relevant experience)[AM2]
- Outstanding interpersonal skills
- Excellent organisational skills
- Flexible and able to work in a fast paced, rapidly changing environment
- Strong sense for compliance and deadlines
- Pharmacy, medicine, dentistry, veterinary medicine
- 10+ years of experience in PV