Pharmacovigilance Safety Scientist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We have an exciting opportunity for a Pharmacovigilance Scientist to join our Benefit/Risk team in Europe and become a vital member of a team that is dedicated to providing high quality medical safety support to a number of our key clients through a variety of activities.

The Pharmacovigilance (PV) Drug Safety Scientist provides expert medical safety input into periodic safety aggregate reports (e.g., DSUR, PSUR/PBRER, ACO, RMP, PADER, bridging reports, signal reports, literature articles, health authority requests/queries and other relevant aggregate reports for pharmaceutical products and biologics/biosimilars).

The PV Drug Safety Scientist will be primarily accountable for authoring aggregate reports, mostly PSURs & PBRERs, as well as DSURs. There will be exposure to signal detection reports as well as an expectation that you will be able to support on literature activities and audit activities when required.

Key Responsibilities

• Authoring key safety reports such as PSURs, PBRERs & DSURs
• Supporting RMP writing activities
• Supporting PADER writing activities
• Supporting audit activities when required
• Provides input and review relevant safety information for signal detection and risk management activities.
• Participates in Business Development activities as requested.
• Performs other activities as identified and requested by management.
• Supports QPPV and management as required.
• Other duties as assigned.

To Apply

• Medical writing experience of Safety reports, such as PSURs, DSURs, PBRERs, etc.
• An understanding of signal detection and however not necessarily in-depth knowledge of performing signal detection activities
• Strong interpersonal, communication and organisational skills
• Fluency in English language, other EU languages is desirable but not essential
• Strong understanding of MS Word & MS Office tools
• Hands on experience with literature reports

What we can give you

• Flexible working environment which can be hybrid or fully remote working
• An opportunity to work with a broad range of clients, from biotech start up to top 10 pharma, and across indications, from oncology to generic medicines
• A fast paced working environment where you will learn a lot and make serious career progression
• A culture of teamwork and success
• A competitive salary and benefits package

If you are interested in learning more about this opportunity, then please do not hesitate to apply and take the next steps by speaking with a member of the Talent Acquisition team.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***