Remote SERM Medical Director - Safety & PV

Alphanumeric Systems; Portugal; Remote; EUR 102,000 - 138,000; Full time

Benefits offered by this job

Health insurance

Teleworking allowance

Job summary

Alphanumeric Systems in Portugal is seeking a SERM Medical Director to lead safety evaluation, risk management, and regulatory interactions for a global pharmaceutical partner. This remote, 1-year contract role offers full-time work from home with a fixed salary and teleworking support.

The ideal candidate has pharmacovigilance expertise, ability to assess safety issues, and strong communication skills to support Health Authority RFIs and cross-functional governance.

Qualifications

• Significant experience in clinical development, drug safety or pharmacovigilance.
• Experience responding to Health Authority RFIs.
• Strong ability to assess benefit-risk and safety evaluation.

Responsibilities

• Lead safety evaluation and benefit-risk assessments for assigned products.
• Support pharmacovigilance and risk management across development and marketed products.
• Contribute to regulatory submissions and health authority interactions.
• Prepare and review responses to RFIs and other information requests.
• Analyze clinical and safety data to support regulatory decisions.

Skills

Clinical development

Drug safety

Pharmacovigilance

Regulatory submissions

RFIs responses

Job description

Alphanumeric Systems in Portugal is seeking a SERM Medical Director to lead safety evaluation, risk management, and regulatory interactions for a global pharmaceutical partner. This remote, 1-year contract role offers full-time work from home with a fixed salary and teleworking support.

The ideal candidate has pharmacovigilance expertise, ability to assess safety issues, and strong communication skills to support Health Authority RFIs and cross-functional governance.