Reporting to the SVP, GDSP, the key focus of the Sr. Manager, Drug Safety Scientist role is on drug safety, evaluation, and risk-management. You will lead the safety scientists in developing signal detection practices and provide leadership for both the GDSP group and external departments regarding signal detection, signal evaluation and risk management. Day-to-day, you will be responsible, in conjunction with the assigned medical director, GDSP, for monitoring and evaluating safety profiles for allocated products. Coordination and administration of the signal detection team and all supporting documentation will be managed by the Sr. Manager, Drug Safety Scientist. Safety science will focus on post-marketing data but will include clinical development molecules as required.  #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• The Sr. Manager, Drug Safety Scientist, in conjunction with the assigned product Medical Director GDSP, is responsible for developing fit-for-purpose and appropriate signal detection strategies for assigned products, utilizing various techniques and detection thresholds based on the molecule characteristics (life-cycle, indication, population, risk profile, etc),
• The Sr. Manager, Drug Safety Scientist partners with the assigned product Medical Director GDSP and will ensure that all safety documentation is accurate and meets global compliance and regulatory requirements.
• Develops and maintains an understanding of the safety profile of assigned product(s) and understand the indication disease background and epidemiology
• Leads the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, PBRERs, DSURs, Pharmacovigilance Plans and Risk Management strategy and Plans.
• Facilitates signal management processes for assigned products (i.e., signal tracking, leading review meetings, etc.) and in collaboration with the Medical Director, GDSP, evaluates safety data and signals as part of ongoing pharmacovigilance activities.
• Authors signal evaluation reports (SERs), or sections of SERs. May review SERs written by more junior safety scientists.
• May review clinical protocols and study reports to ensure safety risk is adequately addressed.
• Contributes to the safety section of the Investigators Brochure (IB).
• Contributes to regulatory authority submissions (NDAs, MAAs, Variations) by reviewing safety data and preparing relevant sections of the submission.
• Conducts or oversees literature reviews for safety information
• Maintains compliance with PVAs regarding exchange of signal or urgent safety information.
• Interacts with other groups to obtain necessary safety related data (i.e., Medical Affairs, Clinical Development).
• Authors or reviews responses to safety questions from regulatory authorities for assigned products.
• Presentation of safety findings to safety teams, product teams and the Global Safety Committee or other leadership committees as needed
• Leads initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, signal management and responding to ad hoc safety questions.
• Provides Safety science leadership in departmental activities, including PSMF maintenance, PVA preparation, SOP development, etc.

EXPERIENCE & QUALIFICATIONS:

• Life-science degree such as PhD in scientific field, pharmacy degree, MS or BS in scientific field, MPH, BS Nursing
• Minimum of 7 years in pharmacovigilance in a pharmaceutical or biotech environment required, with a thorough understanding of signal detection and assessment
• Expert knowledge of FDA safety regulations, EMA safety regulation, GVP, ICH Guidelines, and other applicable regulatory guidance documents; expertise in global pharmacovigilance regulations.
• Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
• Strong understanding of epidemiologic principles
• Highly self-motivated with a demonstrable passion for pharmacovigilance and strong interpersonal skills
• Excellent written English skills
• Ability to present and critically discuss clinical and post marketing safety data in both internal and external discussions
• Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
• Team player with ability to function in a multi-disciplinary and multi-cultural environment
• Good working knowledge of common data processing software (Microsoft Excel, PowerPoint, Word, Business Objects)
• Knowledge of common safety database systems (e.g., Argus) and ability to write accurate database queries for signal detection purposes
• Ability and desire to mentor junior safety scientists

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.