Pharmacovigilance Specialist - English Fluent 1-year contract - 100 %
13.08.2019 | Employee | 100%



Pharmacovigilance Specialist - English Fluent
1-year contract - 100 %

DESCRIPTION

Responsible for end to end management of Safety Data Exchange Agreements (SDEA) / pharmacovigilance (PV) agreements and provision...

Pharmacovigilance Specialist - English Fluent 1-year contract - 100 %



Pharmacovigilance Specialist - English Fluent
1-year contract - 100 %

DESCRIPTION

Responsible for end to end management of Safety Data Exchange Agreements (SDEA) / pharmacovigilance (PV) agreements and provision of PV language for company-wide contracts requiring safety data exchange/PV terms.

The position will work with SDEA Manager:

  • Portraying a professional image of GSK, and using appropriate negotiation and influencing skills, to negotiate, review, and write SDEAs/PVAs with external companies, with appropriate guidance, using standard template text when possible.
  • Working with local affiliates to provide information to them on SDEAs; collect and collate information from them.
ACCOUNTIBILIITES/RESPONSIBILITIES
(deliverables, scope, complexity, impact on strategy, policy, people relationships)
  • Works with guidance from SDEA Manager to negotiate, review and write sections of SDEAs using standard template text to ensure GSK can meet PV regulatory obligations world-wide.
  • Ensures GSK can meet PV regulatory obligations world-wide via robust SDEAs/PVAs with external companies.
  • Conducts routine reviews of SDEAs/PVAs to ensure adherence with global requirements and GSK business practices.
  • Trains internal and external stakeholders, as required, to ensure understanding of the terms of the SDEAs/PVAs.
  • Liaises with relevant business development and legal departments to ensure proposed PV reporting language is appropriately included in relevant agreements.
  • Serves as the point of contact for business partners and internal stakeholders for matters related to SDEA/PVA management.
  • Supports timely update of SDEA/PVA information in the PVA database as required.
  • Routinly maintains information in PVA database and shared areas documenting information as requested
  • Collects, evaluates, analyses and documents information received from local operating company safety departments, with appropriate senior support.
  • Runs standard listings from relevant safety and SDEA databases as required.
  • Administers document storage and archiving as per GSK relevant policies.
  • Interacts with colleagues in Case Processing, SERMs, Legal functions, Business Development, Operating Companies and external companies as necessary.
  • Contributes to projects relating to improvements in processes and systems
  • Performs other duties as assigned
SKILLS AND EXPERIENCE
  • Minimum requirements: BSc or equivalent in life sciences - biomedical sciences, pharmacy or nursing fields preferred,
  • Relevant experience in the pharmaceutical industry demonstrating a sound knowledge of pharmacovigilance regulations and safety data exchange agreements
  • Extensive experience interacting with third parties (e.g., business partners)
  • Business administration and contract management experience - preferred
  • Knowledgeable in PV and GCP legislation - preferred
COMPETENCIES

Technical
  • Knowledge of data collection and manipulation - proficiency in MS Excel for data analysis preferred.
  • Basic database search skills.
Behavioral
  • Good oral and written communication skills.
  • Ability to work with tight deadlines while under pressure; demonstrates planning and organizational skills
  • Results driven with a sense of urgency that ensures timelines within personal control are met
  • Good judgement, common sense and pragmatism
  • Functions as a team player
  • Customer Focus
  • Ability to work independently with only a moderate level of supervision
  • Develops self
  • Able to build and maintain relationships outside of functional area
  • Proactive problem identification
  • Solution oriented

13.08.2019
Employee, 100%

Contact

Kelly Scientific Genève
Amina Oumeziane
Rue du Rhône 114
1204 Genève
Fax: +41227371213
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