DescriptionThe Lead Patient Safety Physician has responsibility for pharmacovigilance risk management activities of marketed and/or investigational compounds on global level. This may include a portfolio of products/investigation compounds within an assigned disease area or TA. In addition to reporting to US line management, this position may matrix report into a Head Risk Management TA CRM, Global Pharmacovigilance.
Duties & Responsibilities- Develop proactive risk management strategies for assigned marketed and/or investigational compounds
- Set and align standards across products/compounds within the assigned portfolio.
- Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities. Oversee and ensure implementation of such activities across assigned portfolio, including:
- Continuous monitoring and further development of the product safety profile
- Safety issue management
- Set-up of safety analyses in both postmarketing and clinical trial databases
- Close collaboration with Global Epidemiology and Medical Affairs on safety-focused clinical and Epidemiologic studies
- Review and medical-scientific input to regulatory documents such as
- Safety components of submission documents for global marketing authorization
- Periodic Benefit Risk Evaluation Reports / PADERs
- Development Safety Update Reports
- Risk Management Plans
- Clinical Overview Statements
- c o Chair the BI-internal Pharmacovigilance Working Group consisting of experts in Pharmacovigilance, Medical Affairs, Epidemiology and Biostatistics and other disciplines as appropriate
- Depending on the status of development of the compound, may be required to strategically lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound, product or portfolio compound/product or project including project management, project-specific training and coaching of team members, review of team output
- Provide updates or coach direct reports to provide updates of the assigned drug's safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU QPPV
- Represent Global Pharmacovigilance in internal and external committees & bodies. This may include high profile committees such as FDA advisory committees, global regulatory authority meetings, Advisory Boards, Board of Managing Directors, congresses.
- Contribute to the further development of pharmacovigilance within BI by staying abreast of state of the art methodology, changes in the regulatory environment and developments and trends in healthcare system and society.
- Lead strategic projects within GPV (e.g. future software solutions, strategic initiatives, addressing changing global regulatory environment).
- In addition to global responsibilities, may represent PV at US-specific cross-functional meetings that require Risk Management support such as MAT, TASC. May serve as liaison from team to VP, GPV-US and provide regular updates to US teams and leadership as needed.
- Contribute to strategic planning regarding US Risk Management topics. May act as designee/substitute for VP, GPV-US or Global Risk Management Therapeutic Area Head at US meetings.
Requirements- US MD or DO degree or international equivalent from an accredited institution.
- In addition, the following are strongly preferred:
- Completion of a US residency or ex-US equivalent.
- Active or inactive US license to practice medicine or international equivalent.
- Total applicable experience (incl. clinical practice, research or relevant industry) of greater than five (>5) years, and a minimum of two (2) years of experience in the pharmaceutical industry or equivalent (preferably pharmacovigilance) required.
- One to three (1-3) years of leadership experience (e.g. projects, teams, initiative) and influencing teams required.
- Potential for people leadership required.
- Strong leadership skills and executive presence required.
- People leadership experience preferred.
- International experience / international exposure in daily business preferred.
- Board certification/experience in a medicine sub-specialty would be an asset.
- Excellent interpersonal and communication skills (both written and oral) required.
- Ability to attend key meetings in person required.
- Highly ethical personality putting patient safety first
- Self-starter and driving personality, willingness to take on responsibilities
- Sound medical-scientific and clinical knowledge and judgement.
- Ability to synthesize large amounts of medical data, draw medical conclusions, and clearly communicate the conclusions.
- Thorough understanding (based on experience) of Pharmacovigilance and Risk Management in a major pharmaceutical company on a global / corporate level, including safety in clinical development and post-marketing safety.
- This role is accountable for proactive risk management of assigned key marketed and/or investigational compound or a product family including continuous assessment of the benefit-risk profile and performing risk minimization as required to ensure safe use in patients.
- Thorough understanding of Pharmacovigilance regulation in major markets and respective need for compliance.
CompensationThe base salary range for this position is $280,000 to $441,000. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here .
