VP, Global Head of Pharmacovigilance and Patient Safety - Oncopeptides
Pharmacovigilance / Safety · Sverige, Europe, Stockholm
We are now looking for a VP, Global Head of Pharmacovigilance and Patient Safety to Oncopeptides. The company, which is listed on the Stockholm Stock Exchange, was founded in Sweden year 2000 and operates globally.
Oncopeptides develops drugs for the treatment of cancer/hematology and is in a very exciting phase of development.
The pharmacovigilance department is accountable for all aspects of drug safety and pharmacovigilance activities for all products and chairs the benefit-risk team (BRT). As Global Head of PV you are accountable for setting the strategic direction within the pharmacovigilance department and in decision-making regarding the safety profile of a product during its life-cycle.
- Accountable for building a high-performing PV team based on in-house safety databases and global coverage for marketed products and products in development.
- Ensure that all safety surveillance activities are conducted to the highest ethical and safety standards, in compliance with GCP, good pharmacovigilance practices (GVP) and regulatory requirements.
- Lead and provide medical expertise input and judgement in safety surveillance activities including periodic safety reports, safety signal detection and patient risk management plans.
- Act as the Pharmacovigilance strategy leader to assigned projects and products.
- Be the safety contact person for Clinical, Regulatory Affairs, Medical Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned projects.
- Provide medical expertise and judgement to Clinical Teams with respect to safety aspects.
- Participate at meetings with regulatory authorities and with Key Oponion Leaders.
- Provide Drug Safety medical expertice and judgements for regulatory submissions.
- Review safety information generated by contracted partners.
- Ensure creation, maintenance and implementation of (D)CSI.
- Medical Doctor, oncologist or haematologist preferred.
- Minimum 5 years of Clinical Practice Experience.
- 10 years of relevant experience in Clinical Development and/or Pharmacovigilance, including Post-marketing commitment studies.
- Knowledge of Pharmacovigilance and signal management tools, analysis and reporting of medical safety issues.
- In depth understanding of the international regulatory environment (e.g. US and European Legislation).
- Able to prioritize activities effectively and to meet multiple deadlines successfully and with attention to detail.
- Ability to manage crises, monitor safety issues and work under pressure.
- Proven track record for building a team and being a peoples-manager for at least 5 years.
- Ability to work independently as well as in a team matrix organization with very little to no supervision.
- Excellent English, written and spoken with strong communication and influencing skills.
Location: Stockholm, Sweden or Europe remote
Welcome to apply through: www.haegercarlsson.com
Questions are answered by Gunilla Haeger +46(0)704 – 619 387, email@example.com or
Anna Wikman +46(0)73-539 33 87, firstname.lastname@example.org