Job Title: PV Country Lead - Indonesia and Vietnam
Location: Jakarta, Indonesia (Additional locations: Ho Chi Minh City, Vietnam)
Job Type: Full-Time
Job Level: Senior
Travel: Minimal (if any)
Overview:
Takeda, a global leader in the development of breakthrough medicines for over 240 years, invites you to join their diverse team working on innovative therapies that make a lasting impact on patients around the world. Takeda fosters an environment where every voice is heard and every idea matters.
Job ID: R0140481
Date Posted: 12/16/2024
By clicking the "Apply" button, you acknowledge that your employment application process with Takeda will commence and your information will be processed according to Takeda’s privacy policies. All information you provide must be true to the best of your knowledge.
Job Description
Role Overview:
Manage and oversee the Pharmacovigilance (PV) relationship within the Local Operating Company (LOC) to provide expert PV support across assigned territories (Indonesia and Vietnam).
Provide oversight and functional expertise to local Patient Safety teams.
Define and implement local PV strategies in collaboration with PV Area Lead.
Key Responsibilities:
Ensure compliance with local legislation and company requirements for PV activities.
Support pharmacovigilance training, risk management plan implementation, and PV system processes.
Collaborate with Commercial BU, R&D, and other PSPV functions to address safety-related issues in the assigned territories.
Promote pharmacovigilance within the organization and contribute to Medical Affairs workshops, Quality Councils, and other relevant platforms.
Serve as the subject matter expert (SME) on PV regulations and safety requirements in the assigned regions.
Lead audits and inspections within the assigned territories and oversee CAPA (Corrective and Preventative Action) activities.
Support the management of PV staff and vendors to ensure compliance with pharmacovigilance standards.
Ensure timely communication of safety issues to the PV Area Lead and other relevant teams.
Required Qualifications:
Health professional with a Bachelor’s degree in Life Sciences (advanced degree preferred).
At least 5 years of experience in pharmacovigilance, ideally at local, regional, or global levels.
Understanding of medical/scientific terminology and PV regulations.
Strong written and oral communication skills in both local language and English.
Ability to prioritize tasks under pressure and resolve problems independently.
Collaborative team player with cross-cultural awareness.
Detail-oriented with excellent organizational skills.
Compensation and Benefits:
Takeda offers a competitive compensation package, including a comprehensive benefits program.
Locations:
Jakarta, Indonesia
Ho Chi Minh City, Vietnam
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full-time
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