Job Description
Role: Medical Director, Pharmacovigilance – Immunology Specialist
Location: Boston, MA
Employment Type: Full-Time
About the Role
We are seeking an experienced Medical Director with expertise in Pharmacovigilance (PV) and a strong background in Immunology to provide strategic and operational medical oversight of drug safety activities across our immunology portfolio. This individual will serve as the medical safety leader for assigned products, driving safety strategy, signal detection, risk management, and regulatory safety submissions while collaborating cross-functionally to ensure patient safety and compliance with global pharmacovigilance requirements.
Key Responsibilities:
Safety Strategy & Oversight
- Serve as the medical safety expert for immunology products across all phases of development and post-marketing.
- Lead safety surveillance activities, including signal detection, risk-benefit evaluation, and proactive risk mitigation strategies.
- Chair or participate in Safety Management Teams and Safety Review Committees.
Case Review & Assessment
- Provide medical review of individual case safety reports (ICSRs), focusing on medically significant and serious cases.
- Oversee aggregate safety data review (PSURs/PBRERs, DSURs) and ensure alignment with regulatory requirements.
Regulatory & Compliance
- Contribute to regulatory safety reports and risk management plans (RMPs), benefit-risk assessments, and labelling updates.
- Act as the medical safety point of contact for regulatory authorities, responding to safety-related queries and inspection readiness.
Cross-Functional Collaboration
- Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and Commercial teams to ensure safety considerations are integrated into development and life-cycle management strategies.
- Provide safety input to clinical trial protocols, informed consent forms, and investigator brochures.
Scientific Leadership
- Monitor emerging safety signals and scientific literature relevant to immunology.
- Serve as the internal subject matter expert on immunology safety, advising on disease mechanisms, immunopathology, and drug safety implications.
Qualifications & Experience
- Medical degree (MD or equivalent) with board certification or specialty training in Immunology, Rheumatology, Allergy/Immunopathology, or a related field.
- Minimum of 7–10 years of pharmacovigilance experience, with at least 5 years in a leadership or senior medical safety role.
- Strong expertise in immunology therapeutic area across multiple indications (e.g., autoimmune diseases, inflammatory disorders).
- In-depth knowledge of global PV regulations (FDA, EMA, ICH, CIOMS) and Good Pharmacovigilance Practices (GVP).
- Demonstrated experience in safety signal detection, risk assessment, and benefit-risk evaluation.
- Excellent communication and leadership skills with the ability to influence at senior levels.
Additional attributes
- Experience with both clinical development and post-marketing safety activities.
- Track record of successful interactions with regulatory authorities.
- Strong scientific publication or conference presentation record in immunology or drug safety.
Offer
- Competitive compensation and benefits package.
- Opportunity to lead global safety strategies in a high-impact therapeutic area.
- Collaborative, patient-focused culture committed to scientific excellence and innovation.