PV Physician Role

We are seeking a highly skilled PV Physician-Medical Assessment professional to join our team.

The successful candidate will be responsible for overseeing and providing medical input to benefit-risk assessment activities. This includes:

• Providing medical review quality control of individual case safety reports, including coding, seriousness, expectedness, and company causality assessments done by vendors.
• Contribution to the scheduling of aggregate reports, risk management plans, and other safety-related documents to ensure all required reports are documented on the report calendar.
• Providing medical input and/or review of Medical Assessment deliverables, including but not limited to aggregate reports, such as PSURs, PBRERs, PADERs, Annual Reports, DSURs, and ACOs.
• Conducting peer quality review of aggregate reports and quality review of reports generated by vendors.
• Supporting PV Scientists in ensuring all aggregate reports are prepared, reviewed, and submitted in line with regulatory requirements.
• Providing medical input to signal management activities for assigned products, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule.
• Signal evaluation: validation of potential signals and ensuring appropriate actions are taken for confirmed signals.
• Summarizing findings and presenting to the Head of Medical Assessment, Regional PV Heads, and Global Head of Global Pharmacovigilance at appropriate forums such as signal management committee.
• Conducting aggregate safety data review on an ad hoc basis to support benefit-risk evaluations.
• Providing medical input to RMPs/REMS and ARMMs as required and reviewing RMPs authored by PV Scientists.
• Preparing and/or reviewing Health Hazard Evaluations and other ad hoc safety reports as requested.
• Contributing to the identification and design of additional risk minimization measures and supporting their implementation in collaboration with PV Scientists, local affiliates, and third-party partners.
• Clinical & Regulatory Activities: Providing medical/safety input to other cross-functional documents, including clinical study protocols, study CRFs, statistical analysis plans (SAPs), coding review, final study reports, dossier documents, and other documents required to support filing activities. Participation in product/project team meetings.
• Providing safety input, advice, and support to commercial, marketing, and Medical Affairs activities as required.
• Labeling document review: providing medical input to reference safety information, Investigator Brochures, product labels, and patient information leaflets to ensure the most up-to-date and accurate safety information is present in all labeling information.
• Regulatory Authority query management: liaising with Regulatory Affairs to respond to PV-related Regulatory Authority queries; coordinating with various stakeholders when finalizing the response, ensuring responses are tracked to closure.

To be successful in this role, you should have:

• A good working knowledge of PV regulations, including FDA, EU, and local requirements.
• Strong data analysis and report writing skills.
• Excellent teamwork and interpersonal skills.
• Strong problem-solving and decision-making skills.

This role offers a unique opportunity to work in a dynamic environment and contribute to the development of safe and effective pharmaceutical products.

You will have the chance to work with a talented team of professionals and develop your skills and expertise in the field of PV.

We offer a competitive salary and benefits package, as well as opportunities for career growth and development.

We are an equal opportunities employer and welcome applications from diverse candidates.

Please submit your application, including your resume and a cover letter, to [insert contact information].