Associate Medical Director Safety Science
Associate Medical Director Safety Science
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Summary:
The Associate Medical Director Safety Science reporting to the Head of Medical Safety Sciences will lead global pharmacovigilance for both marketed and investigational products overseeing safety surveillance risk assessments and managing the benefitrisk profile. The role involves working closely with crossfunctional teams and ensuring accurate safety evaluations throughout the lifecycle of compounds.
Key Responsibilities Include:
- Accountable for and leads safety surveillance risk assessments and safety management for assigned products including timely and thorough safety review as the lead for the Safety Management Team meetings.
- Support decisionmaking through risk/benefit evaluations and safety data analysis.
- Collaborate with crossfunctional teams on clinical trials safety protocols and patient safety issues.
- Supports the development of the clinical safety strategy to be included in the Clinical Development Plan integrated Safety Management Plan and early phase clinical study protocols.
- Working with the Pharmacovigilance Scientist and relevant crossfunctional team members oversees the creation of Risk Management Plans.
- Develop and contribute to safety reports for regulatory submissions and periodic reports.
- Participate in audits inspections and maintain compliance with global pharmacovigilance regulations.
- Accountable for providing rapid and effective communication of important safety issues to PV management with thorough analysis of the issue and proposed mitigation/ management strategies.
- Represents the project team at the enterprise level and for external safety committees and/or Health Authority interactions for issues relating to clinical safety.
Education Registration & Certification:
- Advanced scientific degree (MD PHD PharmD) required MD preferred.
Experience:
- Minimum of 3 years experience in industry with at least 2 years experience in drug safety (e.g. safety signaling risk management and mitigation)
- Excellent medical knowledge and safety surveillance experience in nephrology or immunology preferred.
- Thorough understanding of and ability to interpret patient safety and pharmacovigilance data.
- Understanding of drug safety regulatory requirements for investigational products including ICH 21 CFR and EU GVP regulations
- Experienced in safety data analysis MedDRA coding and global regulatory guidelines.
- Strong communication and organizational skills with the ability to work in a fastpaced environment and adapt to changing priorities.
- Ability to collaborate with internal and external stakeholders to manage complex safety issues.
- Strong interpersonal and communication skills
- Ability to interact with all audiences and clearly and concisely present data strategy and risk assessment.
Physical Demands and Work Environment:
- This is largely a sedentary role; however some filing is required. This would require the ability to lift files open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers phones photocopiers filing cabinets and fax machines.
Travel Requirements:
- Up to 20 travel expected.
Benefits and Perks:
Apellis offers a comprehensive benefits package including a 401(k) plan with company match inclusive family building benefits flexible time off summer and winter shutdowns paid family leave disability and life insurance and more! Visithttps://apellis/careers/ to learn more.
Company Background:
Apellis Pharmaceuticals Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop lifechanging therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy a leading cause of blindness around the world. With nearly a dozen clinical and preclinical programs underway we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information please visit follow us onTwitterandLinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees applicants or any other covered persons because of race color religion creed national origin or ancestry ethnicity sex (including pregnancy) gender (including gender nonconformity and status as a transgender or transsexual individual) age physical or mental disability citizenship past current or prospective service in the uniformed services genetic information marital status AIDS/HIV status smoker/nonsmoker and occupational pneumoconiosis or any other characteristic protected under applicable federal state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. Duties responsibilities and activities may change at any time with or without notice.
Required Experience:
Director
Employment Type
Full Time
