Pharmacovigilance Specialist (6 to 12 months Takeda contract)Apply Now Email Me Job ID SR0045615 Date posted 01/09/2020 Location: Paris, France
We are currently looking for a Pharmacovigilance Specialist for our french office.
The PV Specialist will :
- Manage the PV relationship within the local operating company (LOC) to provide best PV support for the LOC.
- Supports LOCs within the Cluster France, Belgium, Netherlands and Luxembourg
- Collaborate and liaise with PV Affiliate Relations (PVAR) and other Global Patient Safety Evaluation (GPSE) functions to ensure appropriate systems/processes are in place to support the local PV system
- Provide Pharmacovigilance functional expertise and support to LOCs
- In partnership with PVAR defines and implements the local PV strategies as appropriate
- Manages PV activities in the LOC such as commercial team engagements; PSP, MR, suppliers with PV obligations, agreements, PV training, supplier issues etc. This includes working with PV suppliers where appropriate and ensuring a common understanding of the distribution of PV responsibilities is in place.
- Support and facilitate LOC PV interactions with other sub-functions of GPSE and with other LOCs within the Cluster, where applicable.
- Works with PVAR to implement global, regional and local and cluster wide (where applicable) PV strategies at the LOC
- Maintains appropriate stakeholder network with Commercial, LOC and R&D to facilitate implementation of GPSE strategy and serve as a liaison in their assigned territory to prevent gaps between Commercial and GPSE.
- To be the SME of their assigned territory as it relates to regulatory requirements, resourcing, compliance and other factors.
- Establish / Support local PV suppliers (e.g. PV services suppliers as required including establishing appropriate oversight of such suppliers).
- Support LOCs within assigned cluster 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
- Line manage PV resources where appropriate
- Maintains Descriptions of Pharmacovigilance Responsibilities (DPRs) to provide official record of GPSE and LOC delegation of responsibilities.
- Work with Cluster Leads, Process and Compliance leads, Vendor Management/Oversight personnel in support of LOC PV audits/inspections including follow-up and CAPA management.
- Ensure close collaboration with Process and Compliance leads in ensuring QA and compliance disciplines, globally, regionally and locally to best support LOC needs.
- Embrace the Takeda cultural mind-set of “Patient, Trust, Reputation and Business” in the workplace, undertaking personal accountability to live these values as we work within our one GPSE worldwide team and represent our GPSE function inside and outside of the company, as appropriate
EDUCATION, EXPERIENCE AND SKILLS:
- Health professional or life science degree
- Bachelor’s required. Advanced degree preferred.
- Relevant pharmaceutical or health care related industry experience required
- Advanced experience in PV related environments, preferably at local, regional and/or global levels
- Advanced experience of working cross-functionally
- 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
- Well-developed organizational skills
- High standard of computer literacy
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.