Principal Safety Reporting Specialist- Spain

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health . You will be joining a truly  collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

We are looking to hire a Principal Safety Reporting Specialist to join our Pharmacovigilance team in Spain

Summarized Purpose:

Responsible for the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues Leads projects and programs and provides guidance and support to other team members May also be involved in updates to procedures, regulatory intelligence actvities and other initiatives related to safety reporting.

Essential Functions Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. Provides input and feedback to aid the development of program and departmental procedural documents. Shares ideas and suggestions with team members. Takes an active role in the development and implementation of ideas and suggestions. Liaises with relevant departments around safety reporting tasks and attends various meetings as required. Provides input, feedback and guidance to other team members and mentors new starters. Produces metrics and has some involvement in financial project.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health . You will be joining a truly  collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

We are looking to hire a Principal Safety Reporting Specialist to join our Pharmacovigilance team in Spain

Summarized Purpose:

Responsible for the receipt, submission, and subsequent tracking of expedited and periodic safety reports pertaining to the department’s projects Alerts manager to any quality or timeline issues and takes a proactive approach in the identification and resolution of such issues Leads projects and programs and provides guidance and support to other team members May also be involved in updates to procedures, regulatory intelligence actvities and other initiatives related to safety reporting.

Essential Functions Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines. Provides input and feedback to aid the development of program and departmental procedural documents. Shares ideas and suggestions with team members. Takes an active role in the development and implementation of ideas and suggestions. Liaises with relevant departments around safety reporting tasks and attends various meetings as required. Provides input, feedback and guidance to other team members and mentors new starters. Produces metrics and has some involvement in financial project.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, and experience

Knowledge, Skills and Abilities: Excellent knowledge of medical terminology Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements Good time management and multi-tasking skills Strong attention to detail Ability to influence at all levels of the organization Ability to work well in a collaborative team environment Demonstrated initiative and utilizes persuasion and negotiation skills Excellent critical thinking and problem solving abilities Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activities

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme , ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, and experience

Knowledge, Skills and Abilities: Excellent knowledge of medical terminology Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements Good time management and multi-tasking skills Strong attention to detail Ability to influence at all levels of the organization Ability to work well in a collaborative team environment Demonstrated initiative and utilizes persuasion and negotiation skills Excellent critical thinking and problem solving abilities Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activities

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme , ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.