Pharmacovigilance & Medical Affairs Officer

About the role

Labatec Pharma is seeking a dynamic Pharmacovigilance & Medical Affairs Officer to support its global safety and medical information activities. Based in Sintra, the role reports to the Regulatory Affairs Manager and will focus on Switzerland while also contributing to EU expansion and MENA oversight.

Key responsibilities

• Act as Deputy QPPV for CH/EU, ensuring continuity of the PV system.
• Oversee pharmacovigilance activities performed by external service providers.
• Lead negotiation, maintenance and signing of Safety Data Exchange Agreements (SDEAs).
• Coordinate and review Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and other aggregate reports.
• Manage additional Risk Minimisation Measures (aRMMs), including educational material implementation.
• Perform Swiss‑specific literature screening in French and German.
• Maintain and update internal PV and Medical Affairs SOPs.
• Ensure audit and inspection readiness, acting as internal focal point.
• Provide PV training across the Labatec group and act as Scientific Responsible Person.
• Deliver timely Medical Information responses and manage the MIR database with partner reconciliations.

Required profile

• Degree in Life Sciences; advanced degree (PharmD, PhD, MSc) preferred.
• 4‑5 years of experience in Pharmacovigilance, Medical Affairs, Regulatory Affairs or related scientific/regulated functions.
• Strong understanding of EU GVP; Swissmedic experience is a plus.
• Ability to interpret medical, scientific, legal and regulatory information.
• Experience coordinating with regulatory authorities, partners and external service providers.
• Experience reviewing promotional materials and handling Medical Information services.

Required skills

• Pharmacovigilance
• Medical Information management
• Safety Data Exchange Agreements (SDEAs)
• Periodic Safety Update Reports (PSUR)
• Risk Management Plans (RMP)
• Additional Risk Minimisation Measures (aRMM)
• MIR database management
• EU GVP compliance