Senior Safety Scientist

2 weeks ago

Dublin, Dublin City, Ireland Cpl Full time

Drug Safety Scientist - Senior Manager - Hybrid/Remote

The key focus of the Senior 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. Safety Scientist. Safety science will focus on post-marketing data but will include clinical development molecules as required.

RESPONSIBILITIES:


• The Sr. 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. 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.

The successful candidate will have:


•
• Life-science degree such as PhD in scientific field, pharmacy degree, MS or BS in scientific field, MPH, BS Nursing


• Minimum of 6 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


• Strong knowledge of global pharmacovigilance regulations


• Strong organizational skills, timeline management, and ability to work in matrixed teams.

For more information, please contact

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