Las ofertas de “Sanofi”

Caduca pronto Sanofi

Drug Safety Officer - VIE Contract (W/M)

  • Contrato de duracion determinada
  • Barcelona (Barcelona)
  • Marketing

Descripción de la oferta

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.

Therefore, only applications that are submitted in English will be considered.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for a candidate for a VIE mission of:

Drug Safety Officer - VIE Contract (W/M)

Responsibilities:

(PV) Pharmacovigilance Activities related to the assigned therapeutic area of responsibility:

- Handling of cases:

·  Initial collection and monitoring of data, analysis of information, request for additional information and further processing of data in the local PV tool as well as the global database. When receiving the CIOM (Medical International Organisation of Science)s form, determination of regulatory action and notification if applicable to Health Authorities, according to the internal Company procedures and European, national legislation and quality control of such activities

- Review of safety information included in SmPC (Summary of Product Characteristics), Leaflet, Instructions for Use, labeling and packaging material:

·  Analysis and validation of safety information included in SmPC, Leaflet, Instructions for Use, labeling and packaging material versus reference documentation for submission to the Competent Authorities by the Regulatory Affairs department

- Queries:

·  Handling of safety queries received by consumers and healthcare providers

- Training & knowledge & skills:

·  Knowledge and compliance of PV legislation related to drug, medical devices, cosmetics products, food Supplements, pesticides and pediculicides
·  Knowledge of the assigned products and the therapeutic area

- DHPCs (Direct Healthcare Professional Communication), Product Alerts and signal detection:

·  Collaborate with the CSL (Slinical Safety officer) and PV Coordinators in the handling of letters containing safety information sent to Healthcare Professionals
·  Collaborate with the CSL and PV Coordinators in identifying and handling of product alerts
·  Collaborate with the CSL and PV Coordinators in signal detection activities

- Archive:

·  Electronic archive and paper archive if necessary of all documentation related to safety information

- Product Launches:

·  Collaborating with pre and post-launch activities with the product knowledge acquired. Participating in trainings and involvement in post-launch activities. Daily monitoring of information published on the product and competitors, adhoc signal detection, processing and share of information to the Business Unit through dashboard of cases managed in the department

- Monthly reports (AMPAR - Annual Management and Program Analysis Report):

·  Providing information for the preparation of pharmacovigilance monthly activity reports to be sent to GPE

- Training:

·  Carrying out PV Training to the company staff as well as third party associates

- Quality documents:

·  Reviewing and updating local quality documents

- Compliance of local regulations and legislation:

·  Being compliant with local HSE (Health Safety and Environment) regulations, prevention of occupational hazards and environment.
·  Being compliant with Data Protection legislation.
·  Being compliant with local SOPs (Standing Operating Procedures ) established by the company and by Global if applicable

- Other:

·  Attending local or International events sponsored by the company or external training in order to ensure the product knowledge growth
·  Collaborating with the CSL and PV Coordinators in specific projects

Requirements:

·  Master degree in Pharmacy
·  Experience in Pharmacovigilance
·  Pro-active attitude
·  Learning fast and ready to be operative asap
·  Being able to work with deadlines and be on-boarded quickly

- Skills:

·  Rigour, and sense of responsibility, empathy is important in contact with professionals and patients
·  Capacity to work as a team and to interact with other functions
·  English and Spanish both written and spoken

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Hacer que su futuro sea todo un éxito.
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