Senior Medical Director / Global Safety Officer - Drug Safety and Pharmacovigilance
Job Overview :
The Senior Medical Director / Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight, for the assigned investigational and / or marketed products, for the Alkermes Neuroscience portfolio.
Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives.
Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with the cross-functional teams.
This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies.
Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders, both verbally and in writing.
Reports To : VP, Drug Safety & Pharmacovigilance (DSPV)
Responsibilities and Duties :
Provide medical leadership within Drug Safety Benefit-Risk Management Accountable for therapeutic area / product safety oversight and strategies / activities including (but not limited to) : Strategic advisement on clinical development plans, design of clinical protocols.
Responsible for safety content of IB and ICFs and support of DSMBs or Study specific safety review forums for clinical programs.
Strategic safety input for Regulatory documents and benefit-risk content within the Clinical Overview documents, Briefing Books, INDs, Annual reports, labeling etc.
Responsible for the content of any Risk Management Plan, and for the overall risk management and minimization strategies for assigned programs / portfolio, in alignment with internal stakeholders.
Responsible for the content of aggregate safety reports (., DSUR, PSUR, PADER) including assessment of benefit-risk evaluation.
Advisement on the design of post-approval safety studies; Safety SME and contributor for publications, HEOR and epidemiology projects.
Be a resource and the safety expert to DSPV, cross-functional teams and leadership, on matters of safety findings, quality issues, safety regulations and processes, industry standards, and other relevant topics relating to safety input.
- Medical and Safety expertise towards Business Development / Due Diligence activities for Alkermes Neuroscience portfolio.
- Senior Medical Director / Global Safety Officer for assigned investigational and / or marketed products will : Lead product safety surveillance and signaling activities for assigned product(s) in collaboration with DSPV staff.
Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space.
Ensure that routine signaling activities, assessment and investigation are completed and documented in a timely manner. Ability to effectively communicate and respond to product safety queries from all sources including ethics committees and regulatory authorities.
- Lead product benefit-risk assessment and presentation to the Safety Committee and any needed actions to update patient safety information.
- Lead Drug Safety and Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams.
Basic Requirements :
- MD, or MD PhD, or MD MPH required.
- Minimum 10-12 years’ experience in Drug Safety & Pharmacovigilance and / or comparable relevant clinical experience.
Preferred Requirements :
- Prior experience in patient care, clinical development (including early clinical), and / or knowledge of clinical pharmacology desirable.
- Safety / medical experience in the Neuroscience therapeutic space is highly desirable
- Strategic and critical thinking skills
- Leadership as well as the ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies;
to work in an entrepreneurial culture.
- Excellent communication (oral and written) as well as organizational skills.
- Sense of urgency and accountability for both individual and team-owned work products.
- Knowledge of pre- and post-marketing US and EU regulations
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