Senior Director, Regulatory, Quality and Pharmacovigilance

4 weeks ago

United Kingdom ProPharma Full time

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Director, Pharmacovigilance (PV) Case Processing is responsible for setting the strategy and driving the operational goals for the service line, ensuring staff executes according to company standard operating procedures (SOPs) and department operational procedures. The Director acts as a strategic business partner towards key accounts. The Director is a contributing member of the PV Leadership Team and Global Management Committee.

Developing and managing CP Policy:
Contribute to the formation of a long-term vision, as well as formulation of strategic targets, driving operational goals for the CP team including adverse (AE) case processing, AE intake and follow-up, serious adverse event (SAE) review, medical review, safety database configuration support, safety lead functions, out-of-the-box safety report/line listing generation and/or custom report quality review, and reconciliation activities.
Regularly inform Executive Management regarding issues, progress, and developments within the CP group.

Meeting Financial Targets:
Participate in development and management of the CP group's budget.
Regularly evaluate the financial results of the CP team.

Manage direct reports including 1:1 meetings, performance reviews, frequent coaching, and redirection of activities as needed.
Oversee the cohesion between various activities within the CP group and overall PV business to improve efficiency, effectiveness, and quality.
Identify problems, risks, and bottlenecks in work processes and drive change to resolution while mitigating client, regulatory, and company risks.

Performing Relations Management:
Conducts negotiations for complex and sensitive projects with at large clients or commercial partners and manages as such within the CP group.
Identifies necessary changes to improve client satisfaction, provide oversight of quality and compliance, and maintain or provide oversight for governance relationships with clients.
CP activities, including case intake, case triage, case assessment, quality control, secondary/medical review.
CP workflow state management compliance, both within the case workflow and associated with client exchange and/or regulatory compliance.
Monitoring of CP key performance indicators (KPIs) and internal metrics.
Oversee PV document management to ensure that all CP PV-related documents are up-to-date and consistent with one another.
Quality investigations and process improvement strategy for CP-related activities.

Domestic and foreign PV regulatory authority knowledge.
Proficient in use of PV safety databases, preferably Argus and/or ARISg.
Strong management experience including people development, communication skills, and mentoring skills; Flexible and proactive toward changing needs.
Proficiency in MS Office, Salesforce, and Finance Tools.

Minimum BSc level/MSc/PhD preferred.


Experience in commercial negotiations and strategy development.
Proven management and people skills including leading a group of professionals.
Strong experience in client management.
Proven experience as a senior business partner.

We are committed to diversity, equity, and inclusion. Please, no phone calls or emails to anyone regarding this posting.***

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