Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.The manager will supervise the Global Pharmacovigilance Medical Writing team in the coordination, preparation, and completion of Periodic Adverse Drug Reports (PADERs), Periodic Safety Update Reports (PSURs), and other ad hoc safety documentsThe Manager will also write, and prepare aggregate safety documents.
Responsibilities include, but are not limited to:
- Manage, and oversee the preparation of safety documents and submissions, including complex stand alone documents as needed for submission to Regulatory Authorities for all Baxter drug and biologic products
- Write safety documents as needed
- Owner of the report schedules
- Lead projects, establish project deadlines and monitor project progress
- Provide department metrics to senior management, including but not limited to, metrics on PADER regulatory compliance, and initiating appropriate corrective actions as necessary
- Collaborate with the other managers in safety writing to implement standardized global safety writing processes and to maximize efficiencies of the global writing team.
- Collaborate with other safety Writing managers to identify, propose, and implement improvements in safety data evaluation and report writing procedure
- Faciliatate issue resolution between the safety writing team and other groups
- Partner with PVIM to faciliatate data search strategies for PSURs and PADERs
- Act as the technical expert for the preparation of safety documents
- Provide guidance, coaching, and training to safety writers
- Knowledge and understanding of global regulations and guidelines for adverse event reporting
- Experience writing PADERs and PSURs
- Strong leadership qualities
- Proven management experience
- Detail-oriented with strong organizational skills
- Ability to motivate the safety writing team to meet and exceed quality standards and regulatory deadlines for PADER/PSUR reporting
- Project management experience, with demonstrated ability to manage multiple tasks simultaneously
- Excellent communication skills, oral and written
- Strong interpersonal skills and ability to interact with all levels of the organization
- Ability to work well in a matrixed, global team environment
- Bachelor?s degree in a medical / scientific field plus at least five (5) years of pharmacovigilance experience, or a Master?s degree in a medical / scientific field plus at least three (3) years of pharmacovigilance experience
- Thorough knowledge of adverse event reporting, safety surveillance processes and global regulatory requirements
- Exposure to a working relationship with FDA and other regulatory authorities
- Experience writing in an academic research, clinical research, scientific/analytical, or medical affairs setting is a plus
Proficiency for the following competencies are key to success in the Risk Management Group.
Scientific and Technical Analysis ?Use technical medical expertise to analyze safety data in broad terms (Level 4- Guiding)
Submission Project Mgmt ? Oversee communication with key internal stakeholder groups and Regulators (Level 4- Guiding)
Product/Process Quality Standards ? Influence and train others intra-departmentally on pharmacovigilance compliance (Level 4- Guiding)
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
