Description(Senior) Patient Safety Physician has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational compounds on a global level. In additional to reporting to US line management, this position may matrix reports to a Lead Patient Safety physician.
Duties & Responsibilities- Develop or support proactive risk management strategies for assigned key marketed and/or investigational compounds.
- Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
- Chair or support the BI-internal Asset Benefit Risk Team, 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 lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound or product including project-specific training and coaching of team members, review of team output.
- 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 PSPV in internal and external committees & bodies.
- 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
- Contribute to strategic projects within PSPV (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 Patient Safety support. May serve as liaison from team to VP, PSPV-US and provide regular updates to US teams and leadership as needed.
- Represent PSPV during global health authority interactions.
Requirements- US MD or DO degree or international equivalent from an accredited institution required.
- 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.
- Board certification / experience in a medicine subspecialty would be an asset.
- People leadership potential required.
Senior Associate Director:
- Total applicable experience (incl. clinical practice, plus research or relevant industry) of greater than three (3) years required.
Director:
- 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.
Additional:
- 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.
- Good 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.
- Understanding of pharmacovigilance regulation in major markets and respective need for compliance.
CompensationThe Director position offers a base salary typically between $265,000 and $397,400.
The Senior Associate Director position offers a base salary typically between $225,400 and $338,200.
The Associate Director position offers a base salary typically between $190,500 and $285,700.
The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
