Pharmacovigilance Cluster Lead, Gulf, Patient Access and Safety Lead

IND - Bengaluru - Research and Development

Full Time

About the role

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Job Description

Local Patient Safety Lead

You will manage and lead local pharmacovigilance (PV) activities and responsibilities across the assigned countries within the Gulf Local Operating Cluster, in accordance with local regulatory requirements and company standards. You will provide PV expertise and support to the local organization, collaborate with local and global Patient Safety and Pharmacovigilance (PSPV) teams and other internal and external partners, as needed, and partner with the PV Area Lead to implement local pharmacovigilance plans.

Where required and permitted by local legislation, you may also serve as the local Qualified Person for Pharmacovigilance (QPPV), local Safety Responsible, or deputy for these roles.

Global Patient Access and Safety Lead

You will provide oversight and subject matter expertise for patient access programs and initiatives, helping to ensure compliance with pharmacovigilance systems and processes supporting Takeda’s patient access mechanisms. You will identify applicable pharmacovigilance legislation for patient access mechanisms, support related projects, and anticipate future needs to enable timely implementation of local pharmacovigilance activities in accordance with applicable requirements.

You will also lead and assign work to team members supporting operational pharmacovigilance activities for patient access mechanisms, maintain a strong connection with the Patient Safety & Pharmacovigilance Affiliate Management (PSPV-AM) Head, and provide relevant business updates related to patient access safety.

How You Will Contribute

Local Patient Safety Lead

Manage, support, and oversee the pharmacovigilance system within the assigned territory in accordance with local legislation and company requirements, including safety reporting and submissions, training, pharmacovigilance agreements and obligations, risk management plan implementation, cross-functional activities, organized data collection programs, PSMF updates and maintenance, Quality Management System (QMS) activities, vendor oversight, etc.
Work closely with the regional PSPV-AM Liaison and PV Area Lead to support and coordinate local pharmacovigilance interactions with other PSPV teams.
Maintain a network of relevant partners across Commercial, local organizations, and PSPV to support pharmacovigilance plans and help prevent gaps between Commercial, Research and Development, and PSPV activities.
Serve as the subject matter expert for the assigned territory on global, regional, and local regulatory requirements, staffing, compliance, and related factors.
Establish and support local or regional pharmacovigilance vendors, including resident Qualified Person for Pharmacovigilance providers and pharmacovigilance service providers, including support for business continuity, and ensure appropriate oversight is in place where needed.
With support from Global PSPV Compliance and the PV Area Lead, assist with audit and inspection preparation and lead audits or inspections within the assigned territory.
Manage corrective and preventive actions from initiation through closure within the assigned territory.
Escalate any potential safety issue in the assigned territory immediately to the local cross-functional teams, PSPV-AM Head, PSPV-AM Liaison, and PV Area Lead, as appropriate.
Perform local pharmacovigilance operations within the assigned territory, where applicable and agreed with the appointed PV Area Lead.
Carry out local Qualified Person for Pharmacovigilance or local pharmacovigilance contact person activities, or act as a deputy, where required and qualified under local legislation.
Line manage pharmacovigilance resources, where appropriate.

Global Patient Access and Safety Lead

Maintain strong working relationships with Medical and Patient Access teams and other functions involved in patient access to support timely pharmacovigilance input for implementation.
Support the local implementation of global pharmacovigilance access strategies.
Review patient access initiatives to confirm compliance with pharmacovigilance obligations and requirements.
Ensure access oversight tools are used consistently across local organizations.
Identify and track patient access pharmacovigilance oversight measures, data sources, and reporting opportunities that support local, regional, and global policies and pharmacovigilance requirements.
Support local pharmacovigilance audit and inspection activities related to patient access initiatives, as needed.
Define and communicate patient access pharmacovigilance obligations.
Ensure local and regional pharmacovigilance processes are in place to clearly define responsibilities for patient access initiatives in accordance with global standard operating procedures and local regulations.

Skills and Qualifications

Bachelor’s degree in health sciences or a related life science field; an advanced degree is preferred.
Relevant experience in the pharmaceutical or healthcare industry.
Meets all applicable local requirements for the Qualified Person for Pharmacovigilance or pharmacovigilance contact person role, including education, training, and experience.
At least 5 years of experience in pharmacovigilance, preferably at the local, regional, or global level.
Strong understanding of medical and scientific terminology.
Excellent knowledge of pharmacovigilance regulations applicable to the global post-marketing environment and relevant legislation.
Strong written and verbal communication skills in the local language and English, with experience working in virtual teams.
High attention to detail and accuracy.
Flexible mindset and strong cross-cultural awareness.
Collaborative approach and ability to work effectively within a team.
Ability to prioritize effectively under pressure.
Sound judgment, with the ability to resolve problems and conflicts independently.
Strong organizational skills.
Licenses and certifications required under applicable local Qualified Person for Pharmacovigilance or pharmacovigilance contact person requirements, where applicable.

Professional Scope and Leadership

As an expert Patient Safety & Pharmacovigilance professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues that require in-depth analysis and sound judgment.

You engage with key stakeholders outside your immediate area of expertise and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and as an external spokesperson on major matters, often working independently while leading functional teams or projects. You also contribute to the training and mentoring of junior staff.

Benefits

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

Competitive Salary + Performance Annual Bonus

Flexible work environment, including hybrid working
Comprehensive Healthcare Insurance Plans for self, spouse, and children
Group Term Life Insurance and Group Accident Insurance programs
Health & Wellness programs including annual health screening, weekly health sessions for employees.
Employee Assistance Program
5 days of leave every year for Voluntary Service in addition to Humanitarian Leaves
Broad Variety of learning platforms
Diversity, Equity, and Inclusion Programs
No Meeting Days
Reimbursements – Home Internet & Mobile Phone
Employee Referral Program
Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 days)

About ICC in Takeda

Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day.
As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.