Local Safety Responsible (LSR)-FSSA

Job description

  Job facts

Roche is looking for a Local Safety Responsible (LSR) Person. This is an affiliate role i.e holds responsibility for an affiliate (Roche Cote d'ivoire & Roche Cameron) and additional Francophone Sub-Saharan Africa countries as per Pharmacovigilance System Master File (PSMF)

It is to ensure that collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements. Maintains oversight of the management of safety information, safety risk management and all other Pharmacovigilance (PV) activities, ensuring Pharmacovigilance (PV) medical compliance (Roche policies and procedures, global and local regulatory requirements) and inspection readiness for country(ies) within their area of responsibility.

Key Activities and Responsibilities

·  Management of individual case safety report from all relevant sources (solicited and unsolicited sources)
·  Local signal detection for local products (i.e., products without global product support), where applicable
·  Oversight of Pharmacovigilance (PV) medical compliance risk management plan implementation
·  Safety communication
·  Study and program oversight
·  Management of aggregate reports
·  Pharmacovigilance quality
·  Contract review and Pharmacovigilance agreements
·  Labeling and Pharmacovigilance commitments
·  Pharmacovigilance oversight of countries with no Roche presence (where applicable)
·  Management of the Local Safety Unit (as applicable)
·  Monitoring and oversight of service provider management/outsourcing process
·  Pharmacovigilance approver for market research and patient support programs
·  National contact person for Pharmacovigilance.

Qualifications

·  Healthcare professional (medical degree preferred) / Other life sciences background with significant experience in Drug Safety (especially operational PV) can be acceptable Experience
·  Significant experience in Drug Safety (especially operational PV) + qualification per training.
·  Experience in Medical function (e.g. Clinical Research, Medical Information etc.) of a bio-pharmaceutical company preferred.

Competencies

·  Core behaviors: Walk the talk (Accountability) / Be brave (challenge the status quo) / Do it right (serving others),
·  Proven ability to demonstrate Roche Values
·  Leadership and management skills / Organization, planning, strategic thinking, influencing and communication skills
·  Fluency in French and English, written and verbal.
·  Proven ability to interact well in a multi functional team setting.
·  Knowledge: Drug Safety knowledge / Drug Safety relevant regulations

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.