JobDiva # 20-09306
JobDiva # 20-09306
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Associate Director for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The Clients Group is responsible for ensuring the safety of our medicines: The Clients group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
- Associate Director Medical Safety Review provides high quality medical review of ICSRs including the determination of regulatory reportability of clinical trial cases and certain spontaneous reports.
- Associate Director Medical Safety Review performs signal detection based on ICSRs and discusses with relevant stakeholders for further action.
- Medical Review: Provides medical review of individual serious spontaneous reports of adverse events.
- Provides medical review and performs causality assessment and determines regulatory reportability of clinical trial cases for assigned products and across therapeutic areas.
- Provides oversight of single case processing vendor re: medical review for products of responsibility if applicable.
- Compliance: Ensures complete and timely reporting of medical cases to regulatory authorities globally for products of responsibility.
- Collaborate with QST to ensure consistency of work practices and SOPs. Demonstrated ability to apply Client operating philosophy and operate within company policies and procedures and appropriate regulations.
- Collaboration: Partner with WWPS personnel from other functions (AE processors, PV Scientists, ESR safety scientists and Medical Safety Assessment Physicians) in evaluating the safety profile of Client compounds of responsibility.
- Identifies potential safety signals and informs the appropriate safety assessment physician of all potentially important cases and issues.
- Development/Processes: Deals with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Is an active, high energy proponent of the companys commitment to public health.
- Influences and impacts others through clear reasoned argument, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives.
- Represents WWPS within areas of responsibility and competence and experience.
- Ensures that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and safety in accordance with company cost effectiveness goals.
- MD or Equivalent. Board certification and medical specialty
- 2-4 years in clinical practice or relevant setting.
- 1-3 years in pharmaceutical industry (clinical research, pharmacovigilance or Medical Affairs) or equivalent.
- Knowledgeable and skilled in medicine and pharmaceutical product safety.
- Experience applying medical knowledge to the interpretation of individual case review; experience with reporting of individual adverse events.
- Previous experience in the safety field and/or pharmaceutical industry.
- Experience working in a team environment, including supporting other team members when necessary; promote collegiality and teamwork among peers.
- Experience in Argus safety database is preferred.
- Ability think clearly and decisively and present independent, reasoned solutions to identified safety issues, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives.
- Demonstrated creative problem solving skills that enact change and drive continuous improvement.
- Seeks to develop self and others. Aligns objectives with organizational goal.
- Excellent oral, and written English skills
- Excellent communication, interpersonal and time management skills
- Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment.
- Ability to build and manage inter-relationships by motivating and inspiring others.
- Ability to operate with minimal direction.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jay Lucas | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.