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Signal Detection Scientist

Pharmaceutical Product Development (PPD)

Philippines

An exciting opportunity has arisen for a data-minded Pharmacovigilance professional with proficient analytical experience to join us at PPD due to our expanding Signal Detection services. This group supports Clients portfolio of products (innovator, generics, and vaccines). This is mainly a safety and risk management role with primary focus on post-marketing surveillance (some pre-marketing work may be required at times) rather than processing of individual adverse event reports.

We are hiring for the position of Signal Detection Scientist. This role spans a range of job grades within PPD. Your exact seniority and responsibilities will depend on demonstration of the required technical skills and behavioural competencies, and on the nature of the allocated products, though the successful candidate will have over 5 years of experience with aggregate safety data reviews.

The preference for this role is to be based out of our main locations in the Philippines, and for the right candidate, home-based working options will be considered.

You must also have either a life science or healthcare professional background as well as robust Pharmacovigilance analysis experience across several therapeutic areas globally.

This is a role for people with an appetite for science and process-improvement, critical investigation of problems, and seasoned understanding pharmacological principles and regulations. It also requires individuals with a keen eye for detail and reconciliation of data, a pronounced interest in software learning and use along with good aptitudes at quickly and diligently manipulating larger and complex datasets in Excel.

We offer a structured training programme with opportunity for development. This is a fast-paced versatile and challenging role in a growing team that will offer excellent career prospects.

Primary responsibilities include:

· Proactively monitor and evaluate of all aspects of the safety profile of designated products and ensure that suitable options are presented to PPD’s Clients in collaboration with Safety Physicians.

· Prepare signal-detection strategies and routinely perform accurate signal analysis as well as detailed safety evaluations.

· Discuss and manage safety issues through matrix teams and present your findings to high level teams and/or Clients’ governance bodies.

· Ensure that safety documents (e.g. signal evaluations, labelling documents, regulatory enquiries, etc.) are written accurately and in a timely manner to meet global compliance and regulatory requirements.

· If appointed to a senior grade, may operate in a lead capacity for certain projects and direct the work of more junior level staff. Manage the budget and billing, client interactions, and ensure suitable completion of Client services.

· Independently review appropriate resources to develop and maintain knowledge of global regulations, Good Clinical Practices and PPD corporate, divisional and/or client-specific policies and procedures.

· Ensure suitable documentation of all activities, including use of departmental/Client Trackers, preparation of routine reports.

· Support other product-life-cycle-management activities as required when these are contracted to PPD (e.g. Core Safety Information updates).

An exciting opportunity has arisen for a data-minded Pharmacovigilance professional with proficient analytical experience to join us at PPD due to our expanding Signal Detection services. This group supports Clients portfolio of products (innovator, generics, and vaccines). This is mainly a safety and risk management role with primary focus on post-marketing surveillance (some pre-marketing work may be required at times) rather than processing of individual adverse event reports.

We are hiring for the position of Signal Detection Scientist. This role spans a range of job grades within PPD. Your exact seniority and responsibilities will depend on demonstration of the required technical skills and behavioural competencies, and on the nature of the allocated products, though the successful candidate will have over 5 years of experience with aggregate safety data reviews.

The preference for this role is to be based out of our main locations in the Philippines, and for the right candidate, home-based working options will be considered.

You must also have either a life science or healthcare professional background as well as robust Pharmacovigilance analysis experience across several therapeutic areas globally.

This is a role for people with an appetite for science and process-improvement, critical investigation of problems, and seasoned understanding pharmacological principles and regulations. It also requires individuals with a keen eye for detail and reconciliation of data, a pronounced interest in software learning and use along with good aptitudes at quickly and diligently manipulating larger and complex datasets in Excel.

We offer a structured training programme with opportunity for development. This is a fast-paced versatile and challenging role in a growing team that will offer excellent career prospects.

Primary responsibilities include:

· Proactively monitor and evaluate of all aspects of the safety profile of designated products and ensure that suitable options are presented to PPD’s Clients in collaboration with Safety Physicians.

· Prepare signal-detection strategies and routinely perform accurate signal analysis as well as detailed safety evaluations.

· Discuss and manage safety issues through matrix teams and present your findings to high level teams and/or Clients’ governance bodies.

· Ensure that safety documents (e.g. signal evaluations, labelling documents, regulatory enquiries, etc.) are written accurately and in a timely manner to meet global compliance and regulatory requirements.

· If appointed to a senior grade, may operate in a lead capacity for certain projects and direct the work of more junior level staff. Manage the budget and billing, client interactions, and ensure suitable completion of Client services.

· Independently review appropriate resources to develop and maintain knowledge of global regulations, Good Clinical Practices and PPD corporate, divisional and/or client-specific policies and procedures.

· Ensure suitable documentation of all activities, including use of departmental/Client Trackers, preparation of routine reports.

· Support other product-life-cycle-management activities as required when these are contracted to PPD (e.g. Core Safety Information updates).

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

6 years).

In some cases an equivalency, consisting of a combination of appropriate education, trainingand/or directly related experience, will be considered sufficient for an individual to meet therequirements of the role.

We are considering highly motivated candidates with extensive experience of working within a CRO or a Marketing Authorisation Holder’s pharmacovigilance department, who are looking for an opportunity to develop their skills and expertise.

Successful candidates will have demonstrated the following:

• Analytical thinking, with proven ability to analyse clinical safety and scientific data, whilst applying sound judgment.

• Critical thinking, recognizing key issues and providing practical solutions and resolutions based on all relevant information.

• Intimate knowledge of Device Vigilance requirements globally.

• Highly effective communication skills and the ability to present complex data/information at all levels of the organisation and externally to PPD.

• Attention to detail and the ability to work effectively in a matrix environment characterized by tight timelines and changing priorities.

• The ability to apply pharmacovigilance expertise to a range of products across Clients’ portfolio.

• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills, tools and systems.

• In-depth knowledge of international pharmacovigilance requirements (e.g. ICH, EU pharmacovigilance regulations, and CIOMS initiatives) in major countries.

• Strong knowledge of relevant disciplines (e.g. statistics, pharmacoepidemiology) pertinent to safety at the population level and strong computing skills.

PPD is an Equal Opportunity Employer

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

6 years).

In some cases an equivalency, consisting of a combination of appropriate education, trainingand/or directly related experience, will be considered sufficient for an individual to meet therequirements of the role.

We are considering highly motivated candidates with extensive experience of working within a CRO or a Marketing Authorisation Holder’s pharmacovigilance department, who are looking for an opportunity to develop their skills and expertise.

Successful candidates will have demonstrated the following:

• Analytical thinking, with proven ability to analyse clinical safety and scientific data, whilst applying sound judgment.

• Critical thinking, recognizing key issues and providing practical solutions and resolutions based on all relevant information.

• Intimate knowledge of Device Vigilance requirements globally.

• Highly effective communication skills and the ability to present complex data/information at all levels of the organisation and externally to PPD.

• Attention to detail and the ability to work effectively in a matrix environment characterized by tight timelines and changing priorities.

• The ability to apply pharmacovigilance expertise to a range of products across Clients’ portfolio.

• Self-motivated, able to work independently, as well as in multi-disciplinary teams, and with the intellectual flexibility to continually develop and learn new skills, tools and systems.

• In-depth knowledge of international pharmacovigilance requirements (e.g. ICH, EU pharmacovigilance regulations, and CIOMS initiatives) in major countries.

• Strong knowledge of relevant disciplines (e.g. statistics, pharmacoepidemiology) pertinent to safety at the population level and strong computing skills.

PPD is an Equal Opportunity Employer

Job posted: 2020-07-17

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