ASSISTANT DIRECTOR/ ASSOCIATE DIRECTOR/ DIRECTOR, PATIENT SAFETY OPERATIONSSUMMARY:Plays a key lead role in overseeing the multidisciplinary arena of Patient Safety Operations (clinical development and post marketing), supporting the global pharmacovigilance systems and associated processes. Requires close cross-functional collaboration and a deep understanding of interdependent safety data flows as tasks can be assigned as independent projects. Ensures compliance with applicable regulatory requirements and internal procedures while supporting the overall strategy, quality, and efficiency of the Patient Safety and Pharmacovigilance function.
RESPONSIBILITIES: - Lead and oversee day-to-day drug safety operations macro and micro tasks assigned across clinical and post-marketing programs.
- Manage case processing workflows, timelines, and quality assurance in collaboration with internal and external teams.
- Manage Safety vendors to ensure compliance with agreements and KPIs.
- Identify and manage Third Party quality events, associated CAPAs, and further process improvements.
- Maintain blind across all individual studies, conducting Unblinding where applicable as per SOP.
- Support the development, implementation, and maintenance of SOPs, work instructions, and procedural documents related to safety operations.
- Ensure readiness for regulatory inspections and audits; support inspection activities (pre, during, and post).
- Participate in cross-functional initiatives and serve as the safety operations subject matter expert (SME) on project teams.
- Support the pharmacovigilance agreements (PVA) manager in developing the overall agreement to ensure all Safety Operational aspects for that compound is documented and agreed to.
- Other Patient Safety and Pharmacovigilance tasks as assigned and required associate with product launches
- Support growing business partners and vendor collaborations
- Coordinate business partner safety data exchange operations (case transfers, listings, submission responsibilities), ensuring alignment with partner requirements.
- Enhance PV inspection readiness and support with audits (internal and external)
- Maintain audit/inspection-ready documentation (example for PADE FDA Inspection, mock inspections etc)
COMPETENCIES IDENTIFIED FOR SUCCESS:
- Patient-Centricity
- Keeps patient safety and unmet medical needs at the core of all decisions.
- Strategic & Operational Thinking
- Ability to align safety operations with broader development and regulatory strategy.
- Anticipates operational needs and proactively addresses potential risks while maintaining long term department and company vision.
- Leadership & Influence
- Demonstrates strong leadership in managing vendors, cross-functional teams, and safety projects.
- Fosters collaboration across functions such as Clinical, Regulatory, Quality, IT, etc.
- Coaches and mentors team members.
- Pharmacovigilance Expertise
- Deep understanding of global PV regulations, case processing, aggregate reporting, and safety database management.
- Proficient in evaluating operational impacts of new safety-related regulations and guidance.
- Project & Vendor Management
- Manages multiple safety programs and vendors simultaneously with efficiency and accountability.
- Contract experience: Familiarity with legal contracts, terms and conditions, and negotiation strategies.
- Ensures delivery against service level agreements, KPIs, and regulatory timelines.
- Quality & Compliance Orientation
- Demonstrates ownership of documentation, data integrity, and regulatory correspondence.
- Identifies and implements continuous improvement opportunities within PV processes.
- Collaboration & Communication
- Skilled in translating complex regulatory or safety requirements into practical operational guidance.
- Data-Driven Decision Making
- Understands the role of safety data in clinical development and benefit-risk assessment.
- Brings analytical rigor to operational oversight.
REQUIREMENTS:- At least 10 years of working experience within drug safety and pharmacovigilance.
- Degree in life sciences or equivalent experience e.g. HCP; MD not required.
- Excellent communication skills including proficiency in verbal and written English.
- Proficiency in all commonly used Microsoft applications
- Argus experience required; Veeva, eTMF, and EDC preferred.
- Prior involvement in inspections or audits strongly preferred (back or front room).
- Demonstrated ability to manage complex operational projects across global timelines.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003996
Ionis offers an excellent benefits package! Follow this link for more details:
Ionis BenefitsFull Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $132,140 to $268,875
The pay scale for the Assistant Director position is $132,140 to $170,189
The pay scale for the Associate Director position is $164,792 to $221,777
The pay scale for the Director position is $202,235 to $268,875
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
