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. 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.
Job Description
The Director, Pharmacovigilance (PV) India is responsible for supporting the global PV strategy and ensuring operational goals are achieved within the Indian team, ensuring staff executes according to company standard operating procedures (SOPs) and department operational procedures. The Director, Pharmacovigilance India acts as a strategic business partner towards key accounts. The Director's primary focus is both from the customer as well as from the employee experience.
Essential Functions:
Managing adherence to policy:
- Support the PV long-term vision, as well as strategic targets, driving operational goals within the Indian team including adverse event (AE) case processing, AE intake and follow-up, serious adverse event (SAE) review and processing, medical review, safety migration support, literature search, and submission activities.
- Contribute to the PV sales goals by participation in the proposal process and maintaining industry awareness of 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 PV services.
- Regularly inform PV Leadership and Executive Management regarding issues, progress, and developments within the Indian PV team.
Meeting financial targets:
- Participate in management of the PV budget as it pertains to the Indian team.
- Regularly monitor and evaluate the productivity, efficiency, and subsequent financial results of the PV Indian team.
Providing oversight of the Indian team:
- Monitor the Indian group’s resourcing needs as a part of the greater PV resourcing needs, including evaluation of future needs, participation in the recruitment process, and interviewing candidates for potential hire.
- Coach and guide colleagues, act as a role model, and provide real time feedback to foster growth in employees within the framework of the PV quality, productivity, and compliance benchmarks.
- Manage direct reports including 1:1 meetings, performance reviews, frequent coaching, and redirection of activities as needed.
- Support the collaboration between various activities within the CP and literature surveillance groups and the overall PV business to improve efficiency, effectiveness, and quality including monitoring of key performance indicators (KPls) and internal metrics.
- Identify problems, risks, and bottlenecks in work processes and support change while mitigating client, regulatory, and company risks.
Performing relations management:
- Conduct or support negotiations for complex and sensitive projects with at large clients or commercial partners.
- Identify changes needed 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 activities relative to the Indian team following company acquisitions.
- Act as an escalation point for client-related matters, as needed.
- If necessary, directly oversee or train Indian staff on 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.
- Literature search and review tasks.
- Support PV document management to ensure that all PV related documents are up-to-date and consistent with one another.
- Perform quality investigations and participate in process improvement discussions for group activities.
Necessary Skills and Abilities:
- Leadership 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.
- Local language and local legislative knowledge needed.
- Proficient in use of PV safety databases, preferably Argus.
- Knowledge of the products and services contracted, as well as the products and service portfolios of competitors.
- Knowledge and understanding of all social, political, financial, economic, and technical affairs that are strategically relevant to the organization.
- Knowledge of relevant markets and key market players with an optional need to possess a strong network of contacts in this area.
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.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
