Safety Aggregate Report & Analytics (SARA) Specialist 2

We are seeking a highly motivated pharmacovigilance professional to join our Safety Aggregate Report & Analytics (SARA) team. This is an exciting opportunity to take a leading role in safety reporting signal management and benefit-risk evaluation activities supporting both marketed and investigational products worldwide.

Working in a highly collaborative and international environment you will partner with cross-functional stakeholders advise clients and contribute directly to the safety strategies that help protect patients across the globe.

What Youll Do

• Lead the preparation and delivery of key aggregate safety reports including PBRERs/PSURs DSURs PADERs RMPs ACOs and line listings.

• Serve as the primary owner of assigned safety deliverables ensuring quality compliance and on-time execution.

• Lead signal management activities including:

  • Signal detection validation and evaluation

  • Risk assessment and characterization

  • Documentation and tracking of safety signals

  • Development and execution of signaling strategies

• Conduct and oversee literature surveillance for commercialized and investigational products.

• Author responses to regulatory authority inquiries and support safety labeling and benefit-risk documentation.

• Collaborate with global stakeholders across Pharmacovigilance Regulatory Affairs Medical Writing Clinical Research Quality Safety Operations and other functional teams.

• Provide mentorship and guidance to junior team members.

• Support audits inspections process improvements and innovation initiatives.

• Drive project success through effective stakeholder management communication and leadership.

What Were Looking For

• Bachelors degree in Life Sciences field.

• 2-4 years of post-marketing pharmacovigilance experience covering aggregate reporting signal management and benefit-risk assessment.

• Excellent level of English.

• Strong understanding of global pharmacovigilance regulations and guidelines including GVP GCP and ICH.

• Experience authoring or leading aggregate safety reports and regulatory deliverables.

• Strong project management and stakeholder management skills.

• Excellent analytical thinking attention to detail and written communication abilities.

• Ability to work independently while managing multiple priorities in a fast-paced global environment.

Grade: 140

Work modality: home based.