Manager Pharmacovigilance and Medical Device Regulations

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

Competitive compensation for your work

Emphasis on work/life balance

Collaborative and team-oriented environment

Opportunities for professional growth

Diversity and Inclusion

Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

This position can be based in Germany.

The Manager, Pharmacovigilance & Medical Device Compliance is primarily responsible for establishing, maintaining, and continuously developing the company's pharmacovigilance system. In addition, the role is responsible for ensuring compliance with regulatory requirements for medical devices and serves as the interface between pharmaceutical and medical device regulations.

Job responsibilities include, but are not limited to:

Pharmacovigilance (approx. 60%)

Managing and contributing to all pharmacovigilance (PV) activities

Maintaining and continuously improving a pharmacovigilance system

Supporting inspections by national regulatory authorities and providing the necessary support for global pharmacovigilance activities and other regulatory inspections

Establishing processes to ensure pharmacovigilance compliance, including documentation

Creating and maintaining PV SOPs and templates

Ensuring colleagues are trained on local and global SOPs and procedures

Performing reconciliation (line listing) of AE/SAE cases and complaints at the local level in accordance with Sobi AB/Akcea requirements; reviewing monthly ICSR compliance reports and preparing the local periodic check of Pharmalex performance

Reviewing potential late cases from ESPs and Sobi employees

Archiving, processing, and locally documenting all product complaints, as well as maintaining reconciliation lists (line listings) for AE/SAE cases

Collecting, processing, and reporting all drug safety information within the affiliate and to Sobi headquarters, including performing translations and quality checks of safety information as required

Coordinating requests for follow-up information related to all complaints

Training all colleagues/ESPs on pharmacovigilance

Overseeing and implementing pharmacovigilance requirements in third-party partner agreements, including distributors, medical information, clinical development, patient support programs, market research activities, social media, and other digital media activities

Documenting and managing PV-related deviations and CAPAs

Medical Devices (approx. 40%)

Acting as the person responsible for medical device safety in accordance with §6 MPBetreibV (German Medical Devices Operator Ordinance)

Supporting regulatory matters related to medical devices in accordance with the MDR (Medical Device Regulation) and MPBetreibV

Responsibility for vigilance processes for medical devices

Creating, continuously updating, and reviewing relevant SOPs

Monitoring regulatory changes in medical device legislation

Collaborating with external notified bodies and authorities as required

Reviewing medical devices

Qualifications

Completed degree in pharmacy, medicine, natural sciences, or a comparable field of study.

3-5 years of professional experience in pharmacovigilance.

Strong knowledge of EU Good Pharmacovigilance Practice (EU-GVP) requirements.

Knowledge of the MDR/MPBetreibV and medical device vigilance is an advantage.

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.