Aggregate Safety Assessments Manager
Updated: 22 May 2020
The Aggregate Safety Assessments (ASA) Manager is responsible for:
- Contribute to and oversee the periodic aggregate safety reporting activities in Global Pharmacovigilance (GPV) to enhance quality of the company 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 of the company's 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
- Strictly comply with all relevant authorities / regulations
- Contributes to the execution and oversight of the worldwide ASA activities: both in-house and possible out-sourced ASA activities
The ASA Manager will be accountable for:
1. Global ASA Strategies
a. Work within the budget for global ASA management
b. Implement ASA strategy across the entire organization
c. Working closely with the ES and RM members, provide critical support to all of the
Product Responsible Persons (PRPs).
d. May require management of outsourced vendors for periodic/ medical writing e. Report scheduling and tracking of Aggregate Periodic Reports
f. Closely liase with Regulatory Affairs
2. Operations of ASA
a. Contribute to high quality standards to periodic (e.g. PSURs, DSURs) and ad hoc (e.g. benefit-risk assessment documents in response to Regulatory Authority requests) safety reports and other reports authored by other departments (e.g. study protocols, clinical study reports, Investigator’s Brochure, product label), in terms of working with the authors of the safety/medico-scientific sections and contributing to overall analyses and conclusions.
b. Provide expert guidance and close support to all PRPs, and contribute to and monitor operations of PSUR, DSUR and PBRER and others as appropriate
c. 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
d. Build and maintain close cross-departmental and cross-divisional relationships within global pharmacovigilance, including EU-QPPV and JP-QPPV, RA, GMA and Clinical Development
e. Supports preparation of safety-related data for submission to Health Authorities
f. Contributes to quality, accuracy, timeliness and efficiency of ASA activities and results
3. Collaborating with other members of Global Medical Safety and Global Safety Science a. Support the functioning of the PRPs
b. Establish relationship with, and support of, other functions within Global Medical Safety and Global Safety Science
c. Build and maintain close relationships with all functions within GPV, as well as cross- departmental interactions with relevant functions
d. Together with the PRPs, share accountability for responses to both global and regional authorities.
4. Quality Management
a. Supports PV inspection/audit issues contributing to non-PV inspections/audits (e.g. GCP) as necessary and supporting the QPPV office in corrective and preventive action plans related ASA.
b. Maintains up-to-date knowledge on regulations related to ASA Management
c. Contributes towards the development of the pharmacovigilance ASA training curriculum and is responsible for the correct operational content of training materials.
Strategy Development and Execution
Implements 1-3 year Aggregate Safety Assessment specific objectives and plans as part of the overall GSS-ASA strategy and plans. Participates in the successful execution of GSS-ASA vision, mission, objectives and plans.
Contributes to the successful implementation of annual Aggregate Safety Assessment strategic goals and objectives.
- A postgraduate Science or Medical degree or bachelor’s degree in a healthcare field ( PhD, MS, Pharm.D, MD, RN).
- At least 5 years of experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including;
- 1 years pharmacovigilance experience (advanced pharmacovigilance functions from development and post-authorization)
- Significant and demonstrable working knowledge of global pharmacovigilance regulations and guidelines, including US, ICH and EU regulations.
- You're living in The Netherlands and have workpermission, to work here
Skills and competencies:
- Demonstrates effective leadership skills including ability to lead a multidisciplinary team within a matrix environment
- Working pharmacovigilance knowledge of therapeutic areas in which the company operates
- Experience with responsibilities for products/safety projects
- Excellent communications skills with fluent 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 has 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
40 hours per week
This international pharmaceutical company is located all over the world, this job is recuired in Leiden. It turns innovative science into value for patients.
You can come here easly with public transport out Rotterdam, Amsterdam (Schiphol), Den Haag and Leiden.