BioSpace
Website:
biospace.com
Job details:
Build Our Future Together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Global Patient Safety POD, supporting our global programmes in a hybrid role. In this role, you will lead end-to-end ICSR triage and medical review while collaborating with global safety and clinical development teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & Where
Hyderabad, India (Hybrid - three days a week on site)
Discover Your Role
- Oversee Individual Case Safety Report medical review and accurate data capture in Argus.
- Lead triage harmonisation and end-to-end case quality across the India POD.
- Review narratives, author analyses, causality rationale, and reporting decisions.
- Guide expectedness determinations against programmes, products, and approved labelling.
- Oversee clinically appropriate MedDRA coding for adverse events and medical history.
- Partner with pharmacovigilance, risk management, and clinical teams before regulatory submissions.
- Support compounds, case issue resolution, SOP development, process improvements, and inspection readiness.
- You explore artificial intelligence technologies to strengthen pharmacovigilance activities.
This Role Requires
- MD or MBBS with active Indian registration or eligibility.
- 10+ years industry experience, including 7+ years in pharmacovigilance.
- Hands-on ICSR review, narrative authoring, causality assessment, expectedness determination, and MedDRA coding.
- Expert knowledge of ICH E2A, E2B, E2D, and FDA/EMA pharmacovigilance regulations.
- Proficiency with Argus Safety or equivalent safety databases.
- Strong clinical judgement and clear written rationale.
- Global development or marketed product experience preferred.
- GPS POD or insourced pharmacovigilance experience is advantageous.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
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