Director, Pharmacovigilance Case Processing - United Kingdom - ProPharma
Description
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's primary focus is on the CP group both from the customer as well as from the employee experience.
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.
Contribute to the PV sales goals by participation in and/or oversight of proposal process regarding CP activities and maintaining industry awareness of CP task requirements and trends.
Participate in internal and external forms of consultation, dissemination of the vision, objectives, and philosophy of the organization and function as an authority on the department's area of expertise.
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.
Directing the department:
Oversee the CP group resourcing needs including evaluation of future needs, participation in the recruitment process, and interviewing candidates for potential hire.
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.
Responsible for the transition of department activities following company acquisitions.If necessary, directly oversees the activities as listed:
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.
Acts as an escalation point for client-related matters, as needed.
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.
Necessary Skills and AbilitiesStrategic mindset and ability to translate organizational goals into team's objectives.
Strong verbal and written skills; excellent workload prioritization skills.
Experience working in an international and intercompany context.
Domestic and foreign PV regulatory authority knowledge.
Proficient in use of PV safety databases, preferably Argus and/or ARISg.
Knowledge of the products and services contracted, as well as the products and service portfolios of competitors.
Knowledge and understanding of developments in various PV services.
Strong management experience including people development, communication skills, and mentoring skills; capable of resolving conflict in a constructive manner.
Flexible and proactive toward changing needs.
Proficiency in MS Office, Salesforce, and Finance Tools.
Educational Requirements:
Minimum BSc level/MSc/PhD preferred
Experience Requirements:
Experience in commercial negotiations and strategy development.
Proven management and people skills including leading a group of professionals.
Strong experience in client management.
Cross cultural understanding and working across different countries.
Proven experience in the specific area.
Proven experience as a senior business partner.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
ProPharma Group does not accept unsolicited resumes from recruiters/third parties.