Aggregate Safety Assessment Manager
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for an Aggregate Safety Assessment Manager.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
As an Aggregate Safety Assessment (ASA) Manager you will be responsible for contributing to and overseeing the periodic aggregate safety reporting activities in Global Pharmacovigilance (GPV) to enhance quality of pharmacovigilance activities. Additionally, yo will ensure excellence in periodic aggregate safety reports mandated by worldwide regulatory authorities. You will work together with people in the US (5) and Japan (5) and Leiden (3).
You will also contribute to the best practice of periodic aggregate safety reporting activities, as well as ad hoc reporting to ensure the safety of company products. Training of GPV staff on global regulatory requirements and guidelines for periodic reporting is also your responsibility. Furthermore, you will maintain close alliances with relevant functions, both internal (GPV) and external (RA, GMA, Clinical Development) partners to ensure high-quality periodic reporting activities. You strictly comply with all relevant authorities and regulations. Moreover, you contribute to the execution and oversight of the worldwide ASA activities: both in-house and possible out-sourced ASA activities. In this role you report to the Director ASA and contribute to the implementation and successful execution of the GPV mission, objectives and 3-5 year strategic plan.
- Contribute to quality, accuracy, timelines and efficiency of ASA activities;
- Act as subject matter experience on aggregate safety reports;
- Support PV inspection/audit issues contributing to non-PV inspections (e.g. GCP)
- Manage oversight of 10-15 PSURs on a yearly basis.
Who we're looking for
We are looking for a candidate with a postgraduate Science or Medical degree (Ph.D., M.Sc., Pharm.D, MD). You have at least 5 years of experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including:
- 1 year of pharmacovigilance experience (advanced pharmacovigilance functions from development and post-authorisation);
- Significant and demonstrable working knowledge of global pharmacovigilance regulations and guidelines, including US, ICH and EU regulations.
Skills and competencies:
- Demonstrate effective leadership skills including ability to lead a multidisciplinary team within a matrix environment;
- Working pharmacovigilance knowledge of therapeutic areas in which Astellas operates;
- Experience with responsibilities for products/safety projects;
- Excellent communications skills (fluent in English, spoken and written); global mindset;
- Able to lead meetings, present orally and interact with external bodies;
- Able to work effectively and influence across cultures and functions;
- Proven problem-solving skills and able to work independently;
- Able to manage multiple projects simultaneously and excellent time management skills;
- Astute observational and analytical skills with a sense of urgency;
- Accuracy and attention to detail;
- Creative and innovative thinking;
- Able to maintain composure in stressful/adverse situations;
- Able to contribute to strategic decision-making and high-level thinking;
- Results oriented and ability to deliver high-level quality documents.
Additional vacancy information
Contract: Projectmatig dienstverband met CLS Services
Terms: Project for 1 year, fulltime only.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555