Head of Pharmacovigilance & Patient Safety - Oncopeptides
Do you want to play a key role in improving the treatment options for patients with difficult to treat hematological diseases?
On behalf of Oncopeptides we are recruiting a Head of Pharmacovigilance and Patient Safety. Oncopeptides is a global biotech company focused on research and development of therapies for difficult-to-treat hematological diseases. The company uses its proprietary Peptide Drug Candidate platform, PDC, to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. With Pepaxti launched in European markets, Oncopeptides is currently in an exciting phase.
In this role you will be responsible for shaping the strategy of the Pharmacovigilance and Patient Safety department (PV&PS) in alignment with overall company strategy. You will ensure all PV&PS processes including the monitoring of sources of safety information, processing and submitting of adverse events, and continuous assessment of product benefit-risk conform with current regulatory requirements.
The position is based at the company’s head office in Stockholm city and reports to the Chief Medical Officer. Oncopeptides was founded in Sweden in 2000 and is listed on the Stockholm Stock Exchange and currently consists of around 70 co-workers.
Lead the PV&PS department.
Serve as System Owner for PV IT Systems.
Ensure appropriate oversight of external partners/vendors to deliver all PV&PS obligations and activities in accordance with agreements and relevant regulations.
Regularly assess and monitor risks to PV&PS and oversee the implementation of mitigation actions where possible.
Maintain awareness of regulatory and industry evolutions in PV.
Ensure compliance with relevant PV legislation and any safety-related aspects of clinical trials.
Act as senior resource throughout the company, support Global Safety Lead (GSL), the Chief Medical Officer (CMO) and represent PV&PS at Audits/Inspections.
Relevant academic degree.
Extensive experience of global PV, in biotech/pharma clinical trials and post marketing settings.
Experience of PV systems, preferably Veeva Vault Safety
Previous experience of leading PV departments preferred.
Thorough understanding of the global PV regulatory environment with strong knowledge of EU and US regulations, ICH guidelines, and GCP/GVP.
Expert knowledge of PV processes/requirements and touchpoints with other functional areas.
Proven management and leadership skills
Ability to manage highly complex and critical situations, lead difficult or sensitive management initiatives, and act autonomously within area of responsibility.
Excellent organization and communication skills with fluency in written and spoken English.
”Oncopeptides brings hope to patients through passionate people, innovative science and transformative medicines”
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