Director Pharmacovigilance Safety Physician Bucharest

Director Pharmacovigilance Safety Physician
Bucureşti
Bucharest, Bucharest, Romania

The opportunity

As a Director, Pharmacovigilance Safety Physician you will lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout the product lifecycle and provide comprehensive safety information to patients, prescribers, and regulators.

How you’ll spend your day

• Be accountable for medical evaluation/interpretation of aggregate safety data of assigned products and
- assigned products, as required, including, but not limited to, signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and
- hoc safety review/assessments (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests).

• Review complex Health Hazard Assessments and Health Authority requests.

• Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, and signal evaluation review. Act as medical reviewer to assess causality, consolidate safety information from different sources to determine whether a signal qualifies as a risk.

• Support risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures as well as management of these plans throughout the product’s lifecycle. The Safety Physician is responsible to define the important identified risks, important potential risks, and the missing information.

• Represent PV in
- functional Product Label Working Group. Conduct evaluation and determination of safety related sections of the product label, both initial and throughout the product lifecycle; key member for safety related label negotiations with regulatory agencies as well as in the development and maintenance of CCSI.

• Provide PV support and safety contributions to Health Authority submissions and responses. Represent safety during due diligence of products.

• Collaborate with different functional internal (Medical Affairs, Clinical Development, Quality, etc. ) and external stakeholers (KOLs, CROs, etc. ) effectively representing PV position on any safety concerns as well as the overall safety profile of assigned products. Collaborate with other
- functional teams to ensure execution of the safety strategy.

Your experience and qualifications

• Medical Doctor degree

• Clinical practice experience and/or epidemiological degree/training 

• Experience working in pharmacovigilance and drug safety, as a safety physician minimum 5 years

• Proven ability to handle safety surveillance tasks and chair safety committee meetings

• Ability to serve as a subject matter expert 

• Outstanding communication skills with an ability to collaborate with different departments and partner with and influence others without direct authority 

• Ability to work
- functionally within a matrix / international team across multiple
- zones 

• Oral and written fluency in English