Drug Safety Officer
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
About This Role
As Drug Safety Officer you will monitor the safety of products marketed in France or used in Early Access Programs (EAP) to guarantee patients safety and the application of regulations. You will be the contact person for the companys customers (healthcare professionals and patients) about pharmacovigilance (PV) and medical information.
What Youll Do
Monitor and assess thebenefitrisk profile of company products ensuring continuous pharmacovigilance compliance.
Collect document evaluate follow up and archive pharmacovigilance cases ensuring high-quality data entry and case processing in line with regulations.
Leadlocal signal detection off-label use analysis and PML-related activities collaborating closely with global safety teams (SABR).
Act aslocal Pharmacovigilance Safety Expertand serve asDeputy Responsible Pharmacovigilance (RPV)in the absence of the RPV.
Manage interactions withFrench Health Authorities including safety requests regulatory reporting and legal case coordination with Legal Affairs.
Oversee and managepharmacovigilance and medical information vendors ensuring quality compliance and performance.
Develop maintain and deliverPV training materialsfor internal teams and vendors and supervise junior associates and trainees.
Contribute tocontractual and governance documentation including joint operating procedures and PV clauses in commercial and non-commercial agreements.
Handlemedical information requestsfrom healthcare professionals and patients including validation of standard response letters.
Ensurequality assurance and continuous improvement including procedure writing KPI monitoring audit/inspection follow-up reconciliation and management of non-conformities.
Who You Are
You are a proactive and adaptable team player who enjoys working in collaborative cross-functional environments. You naturally anticipate change and contribute to continuous improvement in Pharmacovigilance and Medical Information activities. You build strong positive working relationships with internal stakeholders vendors and external partners and you are comfortable operating in multicultural and international settings. Clear professional and thoughtful in your communication you help support high-quality compliant and patient-focused outcomes.
Required Skills
Pharm.D or MD with minimum 4 years of experience in Pharmacovigilancewithin the pharmaceutical or biotechnology industry.
Strong ability toanticipate detect and evaluate medical risks including safety signals and product quality complaints with appropriate escalation.
Proven experience inpharmacovigilance case management including documentation follow-up data entry and use of safety databases.
Ability toread analyze and produce scientific documentation(reports notes standard letters) with a high level of accuracy.
Excellentwritten and verbal scientific English communication skills.
Strong analytical skills with the ability tointerpret complex scientific and medical informationand assess relevance.
Demonstrated rigor attention to detail and compliance ininformation processing archiving and quality controlin line with regulations and procedures.
Ability to providepharmacovigilance expertise within multidisciplinary and cross-functional teams.
Strong organizational skills with the ability toprioritize workload and work independently while contributing effectively to team objectives.
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
Unclear Seniority
Key Skills
- Risk Management
- Data Entry
- Customer Service
- Hotel Experience
- Construction Experience
- Data Collection
- Military Experience
- Law Enforcement
- Workers' Compensation Law
- OSHA
- Security
- EPA
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
