Associate Director, Safety Physician
vor 5 Monaten
**Jobbeschreibung**:
The safety physician is responsible for maintaining an up-to-date understanding of the safety profile for assigned products and support the development and maintenance of the risk management strategy. This role supports the product safety team in all aspects of pharmacovigilance and risk management activities, both marketed and in development. Key activities include medical analysis and decision making for the development and maintenance of the Company Core Data Sheet, ad hoc aggregate safety reports, periodic safety update reports (PSURs), signal detection activities and risk management plans (RMPs/REMS) and individual case safety reports. They will work in cross-functional teams with counterparts in regulatory, clinical development, pre-clinical, manufacturing/quality, global pharmacovigilance, and other functional areas to identify, evaluate and communicate safety observations relevant to their assigned products. The key responsibilities are the following:
- Proactive monitoring of product safety profile from first in human throughout lifecycle
- Conduct product signalling
- Timely action and communication of findings in safety governance forums
- Present at, or lead, internal safety governance bodies (Safety Management Team, Joint Safety Management Team). Active contributions to internal and external forums (e g., Data Monitoring Committee, Advisory Boards)
- Contributing to and reviewing of key Pharmacovigilance documents such as PSURs, Risk Management Plans, safety sections of CCDS, SmPCs and other labelling documents, IBs, Clinical Trial/ Study Protocols and Final Reports. Providing expert knowledge to ensure that the documents meet the regulatory requirements
- Contribute to label development and scientific regulatory responses
- Participating in NDA/MAA filings, health authority interactions, and FDA Advisory Committee meetings, as applicable
- Participation in audits and inspections as required and contribution to scientific publications, presentations and workshops
- Active, regular utilization of data review, reporting and visualization tools & systems
- Interacting with Agencies such as FDA and EMA as well as NCAs, Affiliates, partner companies and service providers
- Contribute to mentoring and on-boarding of new colleagues
- Work extensively with colleagues from across the globe
- Participate in department decision making and strategy
- Ensure all activities are of the highest safety and ethical standard
**Stellenanforderungen**:
- University degree in Medicine (Medical Doctor)
- At least 2 years of experience as a safety/PV professional, preferably in a global pharmaceutical company
- Good understanding of the clinical practice. Working experience with patient care preferred
- Experience with both developmental and post-marketing products and in interacting with global regulatory authorities
- Solid knowledge of EU and FDA as well as main global PV regulations
- Knowledge of clinical trials, good clinical practices, and ICH guidelines
- Experience with risk management, aggregate reports and signal detection
- Medical writing experience
- Experience with Regulatory Authority Inspections (PV and GCP)
- Experience with collaborations with vendors and business partners
- Excellent strategic decision-making and analytical skills
- Excellent command of the English language
- Team player with excellent communication and interpersonal skills. Strong presentation skills
- Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks
- Statistical and epidemiological knowledge a plus
- Computer literate, especially in the Microsoft Office product rang; document management and safety database skills are preferred
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