Pharmacovigilance ManagerApply NowEmail Me Job ID R0023234 Date posted 09/22/2020 Location: Istanbul, Turkey
With around 30,000 people working in approximately 70 countries we are a truly global partner for better health. By always putting people first, we empower employee so everyone can develop to his or her full potential.
Takeda Turkey operates since 2009 in Turkey; we are providing better health to patients in different therapeutic areas which are Oncology, Hematology, Genetic Diseases, Immunology and GI.
We are currently looking for a strong profiles with the right attitude to join our Pharmacovigilance Affiliate Relations (PVAR) department under the Global Patient Safety & Evaluation functionas “Pharmacovigilance Manager”.
The position is based in Istanbul. Pharmacovigilance Managerwill be directly reporting to PV Cluster Lead Middle East & Turkey who is based in Dubai.
- Manage the PV relationship within the Local Operating Company (LOC) to provide best Pharmacovigilance (PV) support and functional expertise to the LOC(s) within the assigned territory(ies), where applicable
- Ensure compliance to applicable local legislations, company standards and procedures
- Collaborate and liaise with PVAR Cluster Lead and other GPSE functions to ensure appropriate systems/processes are in place to support the local PV system. As such, the role requires effective leadership and partnership with the relevant stakeholders, both internally as externally
- The role requires effective leadership and day to day prioritization of pharmacovigilance (PV) tasks in order to meet the needs of the business and ensure compliance to all applicable local and global PV legislation and company procedures
- In partnership with PVAR Cluster Lead, defines and implements the local PV strategies as appropriate
- Where applicable, the PV Country manager will also act as the local Qualified Person for Pharmacovigilance (QPPV) or Local Safety Responsible (LSR) as per the local applicable PV legislations
- Manages and oversees the PV system in the assigned territory(ies) in accordance with local legislation and company requirements which may include but not limited to conducting safety reporting and submissions, business continuity, trainings, PV agreements and obligations, risk management plan implementations, cross-functional engagements, organized data collection programs, PV vendor/supplier oversight and management. This may include working with PV suppliers where appropriate and ensuring a common understanding of the distribution of the PV responsibilities is in place
- Works closely with the regional PVAR Liaison and PVAR Cluster Lead to support and facilitate LOC PV interactions with other sub-functions of GPSE and with other LOCs within the assigned territory(ies), where applicable
- Maintains appropriate stakeholder network with applicable Commercial BU, LOC and R&D to facilitate and implement GPSE strategies in collaboration with PVAR Cluster Lead, and serve as a liaison in their assigned territory(ies) to prevent gaps between Commercial BU, R&D functions and GPSE
- To be the SME of their assigned territory(ies) as it relates to applicable global, regional and local regulatory requirements, resourcing, compliance and other factors
- Establish and support local and/or regional PV suppliers (e.g. local resident QPPV suppliers, PV services suppliers (incl for business continuity) as required including establishing appropriate oversight of such suppliers, if applicable
- With support from Regional Process and Compliance Lead, and PVAR Cluster lead, assist with audit/inspection preparation and lead the audit/ inspection within the assigned territory(ies). Responsible for CAPA initiation and closure within the assigned territory(ies).
- Communicate all potential safety issues within the assigned territory(ies) immediately to GPSE, Region Head, PVAR liaison, Cluster & Area Lead as appropriate.
- Support LOC(s) within assigned territory(ies), where applicable in collaboration and agreement with the appointed Cluster Lead.
- Perform local QPPV and/or local PV contact person activities where required and trained to do so and ensures 24/ 7 coverage for PV related matters in LOC
- Conducts PV training of all local PV employees, non-PV staff, all sites within the territory and where applicable
- Line manage PV resources where appropriate, help organize resources for efficient functioning of the team, track performance of the PV team (where applicable) using the appropriate metrics
- Responsible for both L-Takeda & L-Shire portfolio in Turkey
- Health professional of life science degree
- Bachelor’s required. Advanced degree preferred
- Relevant pharmaceutical or health care related industry experienced required
- Meets all applicable local QPPV / PV contact person requirements including education, training, experience
- Advanced experience, generally with at least 5 years in PV related environments, preferably at local, regional and/or global levels
- Understanding of medical/scientific terminology
- Excellent knowledge of PV regulations for the post marketing global environment and applicable legislation
- Excellent written/oral communication skills (local language and English) and experience working within virtual teams
- Accuracy and attention to detail
- Flexible mindset
- High degree of cross-cultural awareness
- Team worker with collaborative approach
- Ability to prioritise under pressure
- Decision making capability, and ability to independently resolve problems and conflicts
- Well-developed organizational skills
- Mental Agility: Finds solutions to tough problems
- Results Agility: Delivers results even in complexity and ambiguity situations
- People Agility: Can work easily with a diversity of people
- Change Agility: Challenges the status-quo, develops new ideas to get better results, enjoys leading change efforts
- Self-Awareness: Clearly understands personal strengths and weaknesses, actively seeks feedback, sensitive of impact on others