Do you have experience designing pharmacovigilance (PV) operation activities related to product launches?
Are you looking for an opportunity to take responsibility for safety governance process improvements and ensure its compliance with regulations?
Are you located in California, US, or are you willing to relocate?
Fraser Dove International is partnering exclusively with an innovative organisation specialising in developing drugs to treat rare diseases. Operating worldwide, they are committed to making a difference in patients’ lives.
Our client is seeking a proactive leader to lead the global safety evaluation in the analysis of safety data and manage a team responsible for drug safety surveillance, signal detection, safety evaluation and safety management.
Discover more about our Senior Director, Pharmacovigilance Safety Evaluation opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Senior Director, Pharmacovigilance Safety Evaluation, you will be measured against the following objectives:
1) Identifying, detecting, and investigating safety signals, proactively managing risk, and providing medical safety reviews.
2) Providing medical input into activities associated with serious adverse events from clinical trials and post-marketing adverse events.
3) Focusing on safety governance process improvements and procedures to ensure compliance with appropriate regulations.
What you will do:
As the Senior Director, Pharmacovigilance Safety Evaluation, your duties and responsibilities will include:
- Participating in planning, designing, and supporting all of the US PV operation activities related to enabling US product launch activities.
- Managing on-going product safety as part of the safety governance process.
- Participating in Patient Safety Team (PST) and Corporate Safety Board (CSB) activities.
- Providing leadership in managing on-going safety surveillance, signal detection, risk assessment, risk evaluation and risk management.
- Implementing proactive safety analysis strategies to further define the product safety profile.
- Contributing to safety sections in clinical investigator brochures, risk profiles, protocols, labels, and regulatory reports.
- Providing expert-level consultation on safety risk management, signal detection, and epidemiological issues to a variety of stakeholders.
- Ensuring compliance with the US and international PV regulations.
- Participating in multidisciplinary teams to execute clinical trials, assess new product opportunities, develop a clinical research strategy and product development.
What you will bring:
These are the skills and experience you will need to succeed as the Senior Director, Pharmacovigilance Safety Evaluation:
- Confident decision-maker and ability to make practical, compliant decisions.
- Demonstrated ability to appropriately handle highly sensitive and confidential situations and matters.
- Excellent communication skills and the ability to foster strong and long-lasting relationships.
- First-rate attention to detail and capability of seeing the bigger picture.
- Demonstrated sound judgement and analytical skills.
- Strategic proficiency in crafting an approach to relevant FDA and ICH guidelines.
- Master’s degree and a minimum of 5+ years of experience in pharmacovigilance gained in the pharmaceutical industry.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Medical and dental insurance.
- 401k plan.
- Car/travel allowance.
Got what it takes?
To apply for the Senior Director, Pharmacovigilance Safety Evaluation, click the ‘Apply’ button below or contact the Executive Search Consultant – Daniel Eastwood – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.