Do you want to play a key role in safeguarding patients by driving global pharmacovigilance strategies? Do you thrive in a collaborative, science-driven environment where your expertise directly impacts clinical development and marketed therapies? Then this is the opportunity for you!
About Calliditas Therapeutics
Calliditas is a commercial stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.Calliditas’ lead product, developed under the name Nefecon, has received full approval by the FDA and is commercialized in the US under the trade name TARPEYO®. The product is also after the approval by the European Commission and MHRA commercialized by their partner STADA under the trade name KINPEYGO®. TARPEYO/KINPEYGO® is the first treatment approved for IgA nephropathy by the FDA and EMA, respectively. Nefecon recently received full approval in China and is commercialized in China and some other territories under the name Nefecon® by their partner Everest Medicines.Calliditas is also evaluating setanaxib in clinical studies to address a variety of diseases, including primary biliary cholangitis (PBC), idiopathic pulmonary fibrosis (IPF), Alport syndrome and solid tumors.
In 2024, Calliditas Therapeutics was acquired by Asahi Kasei corporation and the integration is ongoing.
About the role as Director Global Safety Scientist
As Director Global Safety Scientist, you will lead Calliditas’ global pharmacovigilance and product safety strategy across investigational and marketed products. The role oversees medical safety assessments, signal detection, risk management strategies, regulatory compliance, and safety reporting activities, ensuring that programs maintain a positive benefit–risk balance throughout the product lifecycle.The Director Safety Scientist will be an integral member of the global Safety team and collaborate with cross-functional partners including Clinical Development, Medical Affairs, Biometrics, Regulatory Affairs, and external stakeholders such as CROs and regulatory authorities.
Main responsibilities: • Lead pre- and post-marketing safety surveillance activities in compliance with ICH, FDA, EMA, and global pharmacovigilance guidelines.
- Provide scientific and medical input into safety strategy across pre-clinical, clinical, and marketed products.
- Conduct medical review of case safety reports, aggregate safety data, and regulatory submissions.
- Drive safety signal detection, evaluation, and risk–benefit assessments for assigned products.
- Author and review safety-related documents including DSURs, PSURs/PBRERs, RMPs, clinical study reports, regulatory filings, and labeling updates.
- Represent Calliditas in interactions with global regulatory authorities on safety-related matters.
- Contribute to inspection readiness and audit activities ensuring PV compliance.
You will have a strong scientific background and deep expertise in pharmacovigilance and drug safety. They are comfortable leading complex safety evaluations, engaging with regulatory authorities, and providing strategic direction in a fast-paced, innovative biotech environment.
Qualifications:
- Advanced degree in a healthcare field (MD, PharmD, PhD, or RN).• At least 7 years’ experience in the pharmaceutical/biotech industry, with 4+ years in pharmacovigilance or drug safety.• Proven experience in BLA/MAA submissions and regulatory interactions (FDA, EMA).• Strong medical writing skills with experience in safety documents (RMP, DSUR, PSUR/PBRER, ISS, etc.).
- Expertise in risk management and benefit–risk evaluations.
- Proficiency in data interpretation and safety data analysis tools.
- Strong leadership and communication skills with the ability to influence stakeholders across disciplines.• Analytical, detail-oriented, and proactive in identifying risks and solutions.
- Collaborative mindset with the ability to work effectively in international, cross-functional teams.
Calliditas offers a dynamic and entrepreneurial environment where the Director Safety Scientist’s expertise will directly shape the future of their development programs. Employees join a growing international company with a strong pipeline, exciting projects, and the opportunity to make a real difference for patients. Calliditas provides competitive compensation, flexible working arrangements, and a culture built on trust, collaboration, and innovation.
Other information
Start: According to agreementExtent: Full-timeLocation: Stockholm
Does this role as Director Safety Scientist at Calliditas Therapeutics sound like your next challenge? Submit your application today, we at Needo look forward to hearing from you!
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