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 PSURs, RMPs and other aggregate safety reports.
• Manage additional Risk Minimisation Measures (aRMMs), including educational material implementation.
• Conduct Swiss‑specific literature screening in French and German.
• Maintain and update internal PV SOPs and ensure audit/inspection readiness.
• Provide PV training across the Labatec group and act as Scientific Responsible Person.
• Deliver timely, compliant Medical Information responses across all markets.
• Maintain the MIR database and perform periodic reconciliations.
• Update internal Medical Affairs SOPs.

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 functions.
• Strong knowledge of EU GVP; Swissmedic experience is a plus.
• Ability to interpret medical, scientific, legal and regulatory information.
• Proven experience in cross‑functional coordination with authorities, partners and service providers.
• Experience reviewing promotional materials and handling Medical Information services.

Required skills