Are you a safety assessment manager with experience and is safety very important for you? This is your chance!
You are responsible for contribution to excellence in Aggregate Safety Assessment and accountable for compliance with regulatory standards and timely delivery of all global and regional periodic documents of high quality in collaboration with RA and Global PV.
You reports to the Director, ASA and contributes to the implementation and successful execution of the GPV mission, objectives and 3-5 year strategic plan.
You are strictly comply with all relevant authorities / regulations and you contributes to the execution and oversight of the worldwide ASA activities: both in-house and possible out-sourced ASA activities. You provide expert guidance and close support to all PRPs, and contribute to and monitor operations of PSUR, DSUR and PBRER and others as appropriate
You are responsible for:
- Contribute to and oversee the periodic aggregate safety reporting activities in Global Pharmacovigilance (GPV) to enhance quality pharmacovigilance activities and to ensure excellence in periodic aggregate safety reports mandated by worldwide regulatory authorities;
- Contribute to the best practice of periodic aggregate safety reporting activities as well as adhoc reporting to ensure the safety products;
- Contribute to the training of GPV staff on global regulatory requirements and guidelines for periodic reporting;
- Maintain close alliances with relevant functions – both internal (GPV) and external (RA, GMA, Clinical Development) partners – to ensure high quality periodic reporting activities;
- Supporting preparation of safety-related data for submission to Health Authorities.
To qualify for this position:
- You have a postgraduate Science or Medical degree or bachelor’s degree in a healthcare field ( PhD, MS, Pharm.D, MD, RN);
- You have at least 5 years of experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including; one year pharmacovigilance experience (advanced pharmacovigilance functions from development and post-authorization);
- You have significant and demonstrable working knowledge of global pharmacovigilance regulations and guidelines, including US, ICH and EU regulations;
- You have demonstrates leadership skills including ability to lead a multidisciplinary team within a matrix environment;
- You have pharmacovigilance knowledge of therapeutic areas;
- You have experience with taking responsibilities for products/safety projects;
- You have excellent communications skills and speaks fluent English (spoken and written);
- You are able to lead meetings, present orally and interact with external bodies;
- You are able to work effectively and influence across cultures and functions;
- You have proven problem-solving skills and able to work independently;
- You are able to manage multiple projects simultaneously and has excellent time management skills;
- You have astute observational and analytical skills with a sense of urgency;
- You are creative and innovative;
- You are able to contribute to strategic decision-making and high-level thinking;
- You are results oriented and ability to deliver high-level quality documents.
The company is one of the top 20 pharmaceutical companies in the world. As a young and forward-thinking company, she is dedicated to improving the lives of people around the world through the introduction of innovative and reliable pharmaceutical products.
For more information you can contact Geert-Jan Reijmer (Business Consultant) via +316 22 41 83 24.